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7 RELAY NBS Thoracic Stent-Graft with PLUS Delivery System TABLE OF CONTENTS Section Page DEVICE DESCRIPTION...8 RADIOPAQUE MARKER BANDS...8 PLUS DELIVERY SYSTEM...8 INDICATIONS FOR USE...8 CONTRAINDICATIONS...9 WARNINGS AND PRECAUTIONS...9 HOW PRODUCT IS SUPPLIED...10 DEVICE SELECTION...10 CASE PREPLANNING / INDIVIDUALIZATION OF TREATMENT...11 EQUIPMENT REQUIREMENTS...11 THE IMPLANTATION PROCEDURE...12 MAGNETIC RESONANCE SAFETY INFORMATION...15 ADVERSE EVENTS...16 SYMBOLS/DEFINITIONS AND COMPANY ADDRESSES Rev. B

8 DESCRIPTION The RELAY NBS Thoracic Stent-Graft with PLUS Delivery system is an endovascular device intended to treat thoracic aortic pathologies. The Relay NBS Thoracic Stent-Graft is comprised of Duralloy, self-expanding nitinol, stents sutured to a polyester vascular graft fabric. The stent scaffold is a series of serpentine springs stacked in a tubular configuration. These stents are spaced along the length of the graft fabric. Longitudinal support for the stent-graft is provided by a curved nitinol wire called Spiral Support Strut. Additionally, radiopaque markers are placed on the stent-graft to aid visualization and accurate placement. Relay NBS Thoracic Stent-Graft end configurations: The Relay NBS Thoracic Stent-Graft proximal end configuration (Fig 1) consists of a sinusoidal nitinol stent plus a crown-shaped nitinol stent that are both covered with fabric. These covered wires when in position, expand to the vessel wall anchoring the device in place and aid in creating a seal zone oriented to the vasculature. The Relay NBS Thoracic Stent-Graft distal end configuration (Fig 1) consists of fabric covering the nitinol spring evenly about the circumference of the stent-graft Proximal Marker 2. Spiral Support Strut Marker 3. Spiral Support Strut 4. Distal Marker 5. FlexZone 6. Straight End Configuration 4 6 RADIOPAQUE MARKER BANDS All stent-grafts have platinum/iridium radiopaque marker bands (See Fig 1) which indicate the fabric edge and also serve as guides for positioning the spiral support strut. The proximal markers are placed 3mm from the edge of the fabric and the distal marker bands are placed at the edge of the fabric. PLUS DELIVERY SYSTEM The delivery system consists of a series of coaxially arranged sheaths and catheters, along with a tubular handle control system. The delivery mechanism consists of two stages. The first stage consists of a hydrophilically coated introducer (Outer Primary Sheath), which is used to advance and track over a guidewire. The tip of the Outer Primary Sheath contains a preformed curve. Within the first stage is the second stage. The second stage is a flexible sheath in which the stent-graft is compressed. The flexibility of the second stage permits tracking through tortuous and curved portions of the thoracic aorta. The PLUS delivery system has two heat shaped Nitinol wires, called support wires, attached to the delivery system catheter. The distal end of the support wires present atraumatic tips that are tethered to the inferior proximal portion of the graft. The support wires are designed to control the expansion of the inferior portion of the graft and ensure proper apposition against the anatomical inner curvature. These support wires are only present in devices with stent-grafts that are 32mm in diameter and greater. INDICATIONS FOR USE The Relay NBS Thoracic Stent-Graft is intended for the treatment of thoracic aortic pathologies such as aneurysms, pseudoaneurysms, dissections, penetrating ulcers and intramural hematoma, in adult patients (as defined by local statutes). Anatomical/Sizing features specified in Tables 1, 2 and 3 should be observed. 8

9 Delivery System Tip 2. Apex Holder 3. Inner Secondary Sheath 4. Outer Primary Sheath 5. Radiopaque Marker 6. Stationary Grip 7. Shipping Retainer 8. Main Body 9. Flush Port/Stopcock 10. Deployment Grip 11. Controller 12. Stainless Steel Rod 13. Apex Release Retainer 14. Apex Release Grip 15. Guidewire Luer 16. Flushport 17. Handle Body Mark CONTRAINDICATIONS The Relay NBS Thoracic Stent-Graft is contraindicated when patients present with any of the following characteristics/conditions: Pregnancy/lactation. Aneurysm/lesion location not accessible to the delivery system and stent placement. Arterial access size insufficient for delivery system entrance. Treatment of lesion that would require a delivery system with usable length greater than 90 cm. Excessive arterial disease precluding delivery system entrance or passage. Untreatable allergy or history of allergic reaction to radiographic contrast media (x-ray dye). Untreatable allergy or history of allergic reaction to anticoagulants. Systemic infection. Arterial tortuosity not allowing passage of the delivery system. Arterial or aneurysm/lesion size incompatible with stent-graft. Congenital connective tissue disease rendering the aneurysm/lesion untreatable. Mycotic aneurysm/lesions. Aortic inner diameter that cannot accommodate the expanded Inner Secondary Sheath outer diameter of approximately 12mm. Thoracoabdominal aneurysms. Hypersensitivity to polyester or nitinol. Massive thrombus. Bleeding diathesis. Aortic Angulations (radius) less than 15 mm at intended proximal landing zone WARNINGS AND PRECAUTIONS Placement of stent-grafts in the thoracic aorta often requires proximity to the great vessels perfusing the brain, increasing the possibility of thrombus or embolization proximally. Care should be taken to ensure air has been purged from the system. Proximal and distal required landing zones vary with stent-graft size (See Table 3). Excessive aortic tortuosity may result in not being able to properly position the stent-graft or stent-graft kinking with thrombus formation. If balloon modeling is desired, use a compliant balloon equal in size to the largest diameter stent-graft used. Balloon inflation should not exceed 1 atm. Do not use power/pressure injections through the delivery system. Care should be taken with respect to occlusion of dominant intercostals/spinal cord arteries. Care should be taken when treating morbidly obese patients as visualization of imaging may be compromised. Careful consideration should be given to treating patients where tracking through a previously placed endovascular or surgical prosthesis is required. Given the contraindication for pregnant or lactating women, care should be taken when treating women of childbearing potential. Consideration should be given to treating patients with significant comorbidities/high risk for open surgical repair. 15 mm radius The proximal end of the graft should only be placed in curvatures of the thoracic aorta presenting an inner radius of 15mm or greater. Fig 3 * In selected circumstances, the benefits of this procedure may outweigh possible risks. 9

10 HOW PRODUCT IS SUPPLIED The Relay NBS Thoracic Stent-Graft with PLUS delivery system is provided STERILE. DO NOT RESTERILIZE-SINGLE USE ONLY. Re-sterilization of the device for re-use will result in loss of component integrity (e.g., reduction of stent-graft radial force, component cracking or discoloration, etc.). Do not reuse, reprocess, clean/disinfect, or re-sterilize. Reuse, reprocessing, cleaning/disinfection, or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in deterioration of health or death of patients or users. Reuse, reprocessing or re-sterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the end-user. Also, each single-use device carries specific labeling instructions relative to storage, use and handling to minimize exposure to conditions, which could compromise the product, the patient or the user. These conditions cannot be assured once the packaging is opened and discarded. The Relay NBS endoluminal straight (non-tapered) thoracic stent-grafts are available in 4 approximate lengths: 100 mm 150 mm 200 mm 250 mm The straight grafts are available in 2 mm incremented diameters ranging from 22 mm to 46 mm. Tapered stent-grafts are available with proximal diameters ranging from 28 mm to 46 mm, decreasing incrementally by 4 mm over the length of the stent-graft. The product is supplied with the following model designation identified on the label. N:NBS 2 DEVICE SELECTION Tables 1 & 2 address the selection of the appropriate stent-graft diameters for the Relay NBS Thoracic Stent-Graft. Table 3 addresses the recommended healthy landing zone length depending on stent-graft diameter selected. STRAIGHT STENT-GRAFTS (Table 1.) Outer Primary Sheath French Size (O.D.) *Special order 10

11 TAPERED STENT-GRAFTS (Table 2.) TARGET LANDING ZONE (Table 3.) Stent-graft Diameter mm mm mm Proximal Length mm mm mm Stent-graft Diameter mm mm Distal Length mm mm CASE-PREPLANNING/INDIVIDUALIZATION OF TREATMENT Practitioners using the Relay NBS Thoracic Stent-Graft with PLUS delivery system should have a thorough understanding of endovascular procedures and techniques. In particular, the RELAY NBS PLUS device should only be used by physicians and teams with experience and training in vascular interventional techniques, including, but not limited to, training on the use of the Relay NBS Thoracic Stent-Graft with PLUS delivery system. This will include practitioners with formal education/training in vascular surgery, interventional radiology, cardiothoracic surgery and interventional cardiology. Selecting the proper stent-graft with the appropriate length and diameter is paramount to the successful exclusion of the indicated thoracic aortic pathologies. Therefore, measure all parameters needed for proper sizing of the stent-graft carefully. Bolton Medical recommends evaluation of all imaging studies available, i.e., angiograms, CT scans, MRI scans, MRA scans and plain radiographs. Each imaging modality offers additional information to the sizing process. The physical characteristics of the vessel should be evaluated in addition to its size. Factors such as stenosis, atherosclerotic disease, ectasia and tortuosity may affect stent-graft selection and placement strategy. The final stent-graft selection will be the responsibility of the physician. Practitioner must ensure that the access vessel diameter is compatible with the selected delivery system s Outer Primary Sheath French size. The physician and patient (and/or family) should review the risks and benefits when discussing this endovascular device and the need for compliance with follow-ups. Any pertinent actions to be avoided or precautions to be taken should also be discussed. EQUIPMENT REQUIREMENTS Fluoroscopic equipment, including a high resolution image intensifier on a freely angled C-arm which can be ceiling or pedestal mounted or portable will be needed for the procedure. It is desirable if the image intensifier has a complete range of motion to achieve AP projections to lateral projections. Its capabilities should include: Digital Subtraction Angiography High resolution angiography Roadmapping 11

12 Supportive/supplementary equipment:.035 (0,89 mm)/300 cm Meier guidewire.035 (0,89 mm)/260 cm or 300 cm Lunderquist guidewire Guidewire torque device Inflation device with pressure gauge Aortic occlusion balloons Compliant stent-graft modeling balloons of the appropriate size Arterial puncture needles 18G or 19G Nitinol goose neck snare (10-15 mm diameter) Assortment of vascular stents Assortment of angiographic and graduated pigtail catheters Anticoagulation and antiplatelet therapies are performed at the discretion of the physician. Similarly, blood pressure adjustment and spinal cord protection measures are also at the discretion of the physician. PREPARATION (Steps 1 through 7) THE IMPLANTATION PROCEDURE Position the patient on the surgical table where standard aseptic preparation of the surgical site is conducted. (Ensure that a compliant stent-graft modeling balloon of the appropriate size is available if needed. Do not exceed 1 atm pressure with balloon). If a radiopaque ruler is to be used, place it underneath the patient at this time. Drape the patient with sterile surgical drapes leaving exposed the bilateral groin access sites. 1. Verify devices are correct for the patient. 2. Inspect the system packaging for visible tears, breaks or openings. 3. Take the delivery system from the sterile packaging and bring it to the surgical table. Examine the delivery system for structural integrity. DO NOT USE the system if defects are noted. 4. Perform a percutaneous needle puncture of the contralateral common femoral artery. Using the Seldinger technique, place a guidewire well into the abdominal aorta. Remove the needle and place a vascular introducer over the guidewire into the artery. Advance a 5FR (1,7mm) pigtail angiographic catheter over the guidewire to the level of the aortic arch. Remove the guidewire. Perform an arteriotomy of the ipsilateral common femoral artery using umbilical ties or surgical vessel loops for hemostatic control. Introduce a.035 (0,89mm) guidewire into the artery and advance it to the aortic arch. NOTE: Ensure that the controller is in the 1 position, if it is not change it to the 1 position (aligned with the arrow in Fig. 4). To change position, push Controller toward the Main Body Handle and rotate to desired position, then release. Check the distal end of the delivery system to ensure that the Delivery System Tip is properly seated in the Outer Primary Sheath (Fig. 5). If not, correct by moving the Deployment Grip until the Delivery System Tip is properly seated as shown in Fig. 5. Ensure that the tip side hole is not covered by the Outer Primary Sheath (Fig. 5). 5. Keep the controller in the 1 position to prevent premature deployment of the stent-graft. Check that the Shipping Retainer covers the delivery system Main Body. The Shipping Retainer aids in preventing premature release of the stent-graft from the outer sheath. WARNING: Do not remove the Shipping Retainer until the inner secondary sheath is to be advanced out of the outer primary sheath. 12

13 6. Remove silicone tubing from the Flush Port (Fig. 6). Flush the delivery system with heparinized saline through the Flush Port (Fig 7) to purge air from the coaxially situated sheaths. Ensure that a continuous stream of saline exits the tip side hole (Fig 5). It may be necessary to elevate the distal end of the system to different positions to bring air to the highest point for purging. The flush port valve must be closed under pressure to prevent air from re-entering the system. Visually inspect the system for remaining air and repeat if necessary. Then flush the guidewire lumen through the flush port extension tubing (Fig 8). Remove extension tubing after flushing. 7. Important: Activate the hydrophilic coating by wetting the Tip and Introducer Sheath with saline. INTRODUCTION/ADVANCEMENT (Steps 8 through 16) 8. While holding and directing the introducer sheath with one hand and holding the distal handle grip with the other hand, advance the introducer sheath into the artery over the guidewire. The guidewire should always remain in the delivery system while inside the patient. 9. Under fluoroscopic control, advance the Outer Primary Sheath until the Delivery System Tip is just below the intended distal landing zone. If the aorta presents tight tortuosity, the tip should be advanced past the tight curvature(s) of the descending aorta to facilitate navigation of the secondary stage/inner sheath. Do not advance the outer primary sheath into the thoracic arch. If the Outer Primary Sheath cannot be advanced beyond the region of tight curvatures the delivery system should be removed from the patient and an alternate procedure be considered. 10. To advance the secondary inner sheath out of the outer primary sheath, remove the Shipping Retainer from the main body by grasping the fabric tab and pulling it away from the handle body (Fig. 9). Once the secondary inner sheath is advanced, the user will be committed to implant the graft. CAUTION: The Controller must be in the 1 position. 11. While holding the black Stationary Grip so that the Main Body remains stationary, push the gray Deployment Grip forward (towards the Stationary Grip) until the stent-graft s proximal markers reach the proximal landing zone (Fig. 10). Verify that the gray Deployment Grip has reached or passed the black Handle Body mark on the main handle body (Fig. 11). This will ensure that the Inner Secondary Sheath has completely exited the Outer Primary Sheath. Also, the distal stent marker bands will be seen approximately 2cm out of Primary Outer Sheath. If the gray Deployment Grip has not reached or passed the black Handle Body mark while the controller is still in position 1, hold the gray Deployment Grip stationary while pulling the Stationary Grip distally until the gray Deployment Grip reaches or passes the black Handle Body mark, this will ensure that the secondary inner sheath is fully out of the outer sheath. 12. As the Inner Secondary Sheath is advanced out of the Outer Primary Sheath, note the alignment of the Spiral Support Strut by locating the Spiral Support Strut markers under fluoroscopy. 13. Place the C-Arm DSA system into a left anterior oblique position in preparation for the initial angiogram. Check the patient image for the possibility of image corruption such as parallax or image distortion by the fluoroscopic x-ray beam divergence. The central ray should be perpendicular to the area of interest. If the device is to be implanted in a curved section of the aorta, verify that the D-shaped marker on the inner secondary sheath and the Spiral Support Strut marker(s) face the greatest curvature. If radial adjustment is needed, retract the deployment grip to bring the stent-graft to a straight portion of the vessel. When retracting the gray deployment grip, ensure that the distal end of the stent-graft is not pulled into the outer primary sheath (the black Handle Body mark can be used as a reference). It may be necessary to withdraw the whole device a few centimeters to bring the stent-graft to a straight position. After the stent-graft is in the straight position, while holding the stationary grip, rotate the gray deployment grip to manually align the spiral support strut markers toward the greatest curvature of the aorta. The D-shaped marker can be used to aid in this placement (Fig 12). If the round portion of the D-shaped marker is facing the greater curvature, the gray deployment grip should be turned clockwise. If the round portion is facing the 13

14 lesser curvature the turn should be counterclockwise. One to three handle revolutions maybe required before the stent-graft begins rotating. 14. Perform an angiogram of the area of interest and mark the target area. 15. Ensure that the surgical table and patient are locked into position. 16. Finalize the longitudinal placement of the stent-graft in relation to the proximal landing zone by adjusting the gray deployment grip as necessary. Confirm the position of the proximal and distal marker bands as well as the spiral support strut markers. If the gray Deployment Grip reaches its maximum travel before the stent-graft reaches the landing zone, the whole device should be advanced. Before advancing the whole device, the gray Deployment Grip should be retracted so as to re-capture the distal stent within the outer primary sheath. At this point, the entire delivery system is advanced as needed. Since the distal stent is captured within the outer primary sheath, the gray deployment grip should be advanced once more until the stent-graft reaches the proximal landing zone and the distal stent is out of the outer primary sheath. Ensure the gray deployment grip has reached or passed the black Handle Body mark. The inner sheath with the stent-graft should appose the vessel s greater curvature to optimize stability and ensure proper conformance of the graft along the vessel. When the deployment of the proximal end takes place in a straight portion of the descending aorta, the tip should appose the vessel s wall to ensure proper alignment of the graft along the vessel. CAUTION: Failure to properly appose the device could result in an angulated proximal end of the stent-graft. DEPLOYMENT (Steps 17 through 19) 17. With the stent-graft in the desired deployment position, turn the Controller to the 2 position (Fig. 13). CAUTION: Verify that the Controller is in the 2 position during steps 18 through While holding the Stationary Grip fixed, retract the Deployment Grip (Fig 14a) by pulling down the Inner Secondary Sheath until the first covered stent begins to expand. The Inner Secondary Sheath has the D-Shaped radiopaque marker (See Fig 12) located between the stent-graft proximal marker and most proximal spiral support strut marker. This marker can be used to visualize the Inner secondary sheath s movement under fluoroscopy. The D-shaped marker should not be retracted past the proximal spiral support strut marker to still allow linear re-adjustments (Fig 15). If the D-marker is moved beyond the proximal spiral support strut marker the proximal end of the graft would have expanded too much too allow repositioning. 19. If necessary, make any final linear position adjustments (proximally or distally) by first changing the controller to position 1. Then using the gray Deployment Grip, move the stent-graft proximally or distally to the desired location. After the stent-graft is in the desired location, move the controller setting back to position 2. RELEASE (Steps 20 through 23) 20. To release and deploy the stent-graft, completely retract the Inner Secondary Sheath by holding the Stationary Grip fixed and retracting the Deployment Grip with one continuous and controlled motion without stopping until the stent-graft is fully deployed (Fig 14b). When the deployment of the proximal end takes place in a straight portion of the descending aorta, the deployment should be done at a quicker pace. CAUTION: Failure to continuously deploy the stent-graft will cause blood pressure to increase and may result in distal migration of the device during deployment. Failure to rapidly deploy the stent-graft when in a straight portion of the descending aorta may result in an offset of the proximal end of the stent-graft. 21. Attachment of the proximal end of the stent-graft is maintained by the Apex Holder. To release the stentgraft from the Apex Holder, go to the thumbscrew on the Apex Release Retainer. Loosen the thumbscrew by rotating counterclockwise 2-3 turns (Fig 16). 22. Lift and remove the Apex Release Retainer. 14

15 23. Under fluoroscopic control, release the Covered Stent by pulling the Apex Release Grip (Number 3, Fig 17) towards the Guidewire Luer until it reaches the end of the Stainless Steel Rod. The stent-graft is now in final position. Note: For devices with the Support Wire (32mm-46mm proximal diameter devices) the retraction of the support wires can be observed at this time. CONCLUSION AND REMOVAL (Steps 24 through 31) 24. Place the Controller in the 4 position. 25. Under fluoroscopic control, retract the Stainless Steel Rod ensuring that the guidewire is against the greater curvature. Pull the Stainless Steel Rod distally until the tip rejoins the outer sheath (Fig 18). During this process the support wires will completely disengage from the Relay NBS Thoracic Stent-Graft. CAUTION: Perform this step carefully and under fluoroscopic control, monitoring the travel of the delivery system tip through the deployed stent-graft so that stent-graft s position is not affected. If the tip does not rejoin the outer sheath easily, apply slightly greater force until the tip seats properly. 26. Withdraw the entire system from the patient. 27. Perform a final angiogram to assess for any endoleaks and/or migration. Confirm successful aneurysm/ lesion exclusion. 28. If an endoleak is detected, consider balloon modeling to correct the leak. CAUTION: Do not exceed 1 atm balloon pressure. Always recheck position of stent-graft following ballooning. 29. Straighten the angiographic pigtail catheter and remove the catheter and sheath from the percutaneous puncture site. 30. Perform standard surgical closure of the arteriotomy site. 31. Assess blood flow to the distal extremities. MAGNETIC RESONANCE SAFETY INFORMATION The Relay NBS Thoracic Stent-Graft was determined to be MR-conditional. Specifically, when present in a patient undergoing a magnetic resonance imaging (MRI) procedure at 3-Tesla or less will not create an additional hazard or risk to the patient under the conditions used for the testing. Magnetic resonance imaging (MRI) procedures must be performed according to the following guidelines: A patient with the Relay NBS Thoracic Stent-Graft may safely undergo an MRI procedure using an MR system with a static magnetic field of 3-Tesla or less. The Relay NBS Thoracic Stent-Graft system does not exhibit magnetic field interactions with respect to translational attraction (tested at a maximum spatial gradient, 3.3-Tesla/meter) and showed no torque during exposure to a 3-Tesla MR system. Therefore, there is no additional risk to a patient with the Relay NBS Thoracic Stent-Graft with respect to movement or dislodgement using an MR system with a static magnetic field of 3-Tesla or less. In addition, because of the lack of magnetic field interactions at 3-Tesla, an MRI procedure may be performed on a patient immediately after implantation of the Relay NBS Thoracic Stent-Graft. MRI procedures must not exceed exposures to radiofrequency (RF) fields greater than a whole-body averaged specific absorption rate (SAR) of 2.0-W/kg for 15 minutes at 3-Tesla in a patient with the Relay NBS Thoracic Stent-Graft. Safety information for magnetic resonance imaging (MRI) procedures pertains to the use of MR systems with static magnetic fields of 3-Tesla or less (maximum spatial gradient 3.3-Tesla/m) and a whole body averaged specific absorption rate (SAR) of 2.0W/kg for 15 minutes of MR imaging. The effects of performing MRI procedures using MR systems with static magnetic fields greater than 3-Tesla and other conditions have not been determined. 15

16 ADVERSE EVENTS Adverse events that may occur in conjunction with endovascular procedures include, but are not limited to those listed in the following section. Fever Post Implantation Syndrome Hematoma Blood Loss Hemorrhage Infection Cardiac events Anaphylaxsis Vessel Dissection Vessel Occlusion/Thrombosis Vessel Damage Emboli Hepatic failure Ischemia (spinal cord, perfusion pathways) Renal failure or Complications Aneurysm / Lesion Rupture Arteriovenous fistula / aorto-esophageal fistula Radiation overexposure or reaction Pseudoaneurysm - In the event of surgical removal or postmortem examination, please contact Bolton Medical for guidance on removal and disposal of implant. SYMBOLS/DEFINITIONS Transient ischemic Attack Cerebral vascular accident (stroke) Congestive heart failure Paralysis/Paresthesia/Paraparesis Death Incision Site Complications Limb ischemia Delivery system failure Access failure Stent graft misplacement Endoleak Stent graft migration Stent graft failure Wire form fractures Suture fracture Deployment failure Perforation Device dehiscence Stent-graft tearing/wear Do not Re-use Do not Re-Sterilize Model/Catalogue Number Use By Caution MR Conditional Date of Manufacture Manufacturer Lot Number Store in a cool, dry place Do not use if package is damaged Sterilized by Irradiation Consult Instructions for use MANUFACTURER: BOLTON MEDICAL ESPAÑA, S.L.U. C/NEWTON, SANT ESTEVE SESROVIRES BARCELONA, SPAIN TELEPHONE: FACSIMILE: LOCATION: BOLTON MEDICAL, INC 799 INTERNATIONAL PARKWAY SUNRISE, FLORIDA USA TELEPHONE: FACSIMILE:

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