INFORMATION FOR YOU AND YOUR FAMILY. Melody Transcatheter Pulmonary Valve Therapy

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1 INFORMATION FOR YOU AND YOUR FAMILY Melody Trascatheter Pulmoary Valve Therapy

2 This booklet is provided to help you ad your loved oes lear more about Melody Trascatheter Pulmoary Valve (TPV) Therapy. Please discuss ay questios with your heart doctor. Oly your doctor ca help you decide if Melody TPV is the right therapy for you. At Medtroic, our culture cotiually ispires us to push the boudaries of medical techology to help patiets live better, loger lives. Melody Trascatheter Pulmoary Valve (TPV) Therapy demostrates our commitmet to providig iovative therapies for the lifetime maagemet of patiets with cogeital heart disease. With Melody TPV Therapy, childre ad adults with failed pulmoary surgical valves or coduits have a prove treatmet optio desiged to restore pulmoary valve fuctio ad delay the eed for surgery. Thousads of patiets from aroud the world have beefited from this therapy sice it became available i Europe i 2006.

3 TABLE OF CONTENTS 1-2 ABOUT THE HEART Cogeital Heart Disease How The Heart Works What Heart Valves Do 3-4 PULMONARY VALVE CONDITIONS AND VALVE FAILURE Pulmoary Valve Coditios Pulmoary Surgical Valve or Coduit Failure Pulmoary Surgical Valve or Coduit Failure Symptoms 5 PULMONARY VALVE FAILURE TREATMENT OPTIONS Surgical Valve or Coduit Replacemet Balloo Agioplasty/Valvuloplasty Trascatheter Pulmoary Valve Therapy 6 MELODY TRANSCATHETER PULMONARY VALVE (TPV) THERAPY About Melody TPV Therapy Is Melody Right For You? Whe Melody Is t A Optio 7-8 THE MELODY TPV PROCEDURE Durig The Procedure After The Procedure Follow-Up Care 9-14 RISKS AND BENEFITS Risks You Should Kow Other Possible Risks Associated With Melody TPV Melody TPV Therapy Beefits Importat Iformatio About Stet Fracture 15 ADDITIONAL WARNINGS AND PRECAUTIONS Warigs Precautios 16 FREQUENTLY ASKED QUESTIONS 17 RESOURCES Olie Resources Medtroic LifeLie Techical Support This therapy is ot for everyoe. Please cosult your physicia. A prescriptio is required. For further iformatio, please cotact Medtroic at Please see page 9 for importat risk iformatio.

ABOUT THE HEART Cogeital Heart Disease Cogeital (from birth) heart disease (CHD) is the most commo birth defect, affectig eight i oe thousad ifats bor each year. There are may differet types of CHD.

Pulmoary Valve Right Atrium Tricuspid Valve Right Vetricle Aorta Pulmoary Artery Left Atrium Aortic Valve Mitral Valve Left Vetricle How The Heart Works A healthy heart beats about 100,000 times a

4 ABOUT THE HEART Cogeital Heart Disease Cogeital (from birth) heart disease (CHD) is the most commo birth defect, affectig eight i oe thousad ifats bor each year. There are may differet types of CHD. Most have to do with a heart that does t develop like it should or with problems with the large blood vessels (the pulmoary artery, ad/or aorta) coected to the heart. Pulmoary Valve Right Atrium Tricuspid Valve Right Vetricle Aorta Pulmoary Artery Left Atrium Aortic Valve Mitral Valve Left Vetricle How The Heart Works A healthy heart beats about 100,000 times a day ad pumps about five quarts of blood each miute or 75 gallos (284 liters) of blood every hour. A ormal heart has four chambers. The upper two chambers are the right ad left atria. The lower two chambers are the right ad left vetricles. Blood is pumped through the four heart chambers with the help of four heart valves the tricuspid, pulmoary, mitral ad aortic valves. The heart s job is to supply the body with oxyge-rich blood. First it seds blood without ay oxyge to the lugs to get oxyge. It the returs it to the heart where the blood cotaiig oxyge will be pumped to other parts of the body. 1

What Heart Valves Do Heart valves ope whe the heart pumps to allow blood to flow forward, ad close quickly betwee heartbeats to make sure blood does ot flow backward.

5 What Heart Valves Do Heart valves ope whe the heart pumps to allow blood to flow forward, ad close quickly betwee heartbeats to make sure blood does ot flow backward. Ay problem with this ormal flow will make it difficult for the heart to effectively pump the blood where it eeds to go. Tricuspid Valve sits betwee the right upper chamber (right atrium) ad the right lower chamber (right vetricle). The tricuspid valve directs blood flow from the right upper chamber to the right lower chamber. Pulmoary Valve directs blood flow from the right lower chamber (right vetricle) ito the pulmoary artery, which splits ito two arteries so that the blood from the body ca get to both lugs. Mitral Valve sits betwee the left upper chamber (left atrium) ad left lower chamber. The mitral valve directs blood flow from the left upper chamber ito the left lower chamber. Pulmoary Valve Aortic Valve Aortic Valve directs blood from the left lower chamber (left vetricle) ito the aorta. The aorta is the major blood vessel that leads from the left lower chamber to the rest of the body. Mitral Valve Tricuspid Valve 2

PULMONARY VALVE CONDITIONS AND AND VALVE FAILURE Pulmoary Valve Coditios If your doctor has recommeded that you read this booklet, you may have oe of the followig cogeital heart coditios that most

6 PULMONARY VALVE CONDITIONS AND AND VALVE FAILURE Pulmoary Valve Coditios If your doctor has recommeded that you read this booklet, you may have oe of the followig cogeital heart coditios that most commoly affect the pulmoary valve: 3 Pulmoary Atresia A coditio where the pulmoary valve has o opeig for blood to flow through. This meas that blood caot go to the lugs to pick up oxyge. Tetralogy of Fallot A coditio which refers to four heart defects that usually occur together; a hole betwee the right ad left pumpig chambers of the heart (vetricles), a arrowed path betwee the heart ad the lugs, a artery (aorta) that is coected to the heart closer to the right side of the heart tha ormal, ad a thicker tha ormal pumpig chamber (vetricle) o the right side of the heart. Double Outlet Right Vetricle A coditio i which both mai arteries, oe that carries blood to the lugs (pulmoary artery) ad oe that carries blood to the rest of the body (aorta), are coected to the right lower chamber of the heart (vetricle). Usually, the aorta is coected to the left lower chamber of the heart. Childre ad adults with these coditios have damaged, arrowed or abset pulmoary valves ad eed surgery for placemet of: Right vetricular outflow tract (RVOT) coduit - a tube that coects the flow of blood from the heart to lugs Artificial tissue valve - made of aimal tissue, ofte from a pig or cow

Pulmoary Surgical Valve or Coduit Failure Over time, mieral deposits may build up o the surgical valve or coduit (calcificatio), ad it may become arrowed ad/or leaky.

7 Pulmoary Surgical Valve or Coduit Failure Over time, mieral deposits may build up o the surgical valve or coduit (calcificatio), ad it may become arrowed ad/or leaky. This may happe as you outgrow your surgical valve or coduit, or as it wears out from the pressures of pumpig blood or from calcium build up. Narrowig (Steosis) The surgical valve or coduit opeig is arrowed, which limits blood flow from the heart to the lugs ad forces the heart to work harder tha ormal. Steosis may be caused by a build up of mierals o the surgical valve or coduit walls (calcificatio). Steosis ca make the heart muscle thick ad prevet it from workig well. It ca also limit the amout of blood pumped to the lugs. Pulmoary Surgical Valve or Coduit Failure Symptoms Becomig tired or short of breath with activity Feelig tired, dizzy or too weak to do your ormal activities Irregular heart beats or the feelig that your heart is racig or poudig i your chest Faitig or ear faitig Symptoms ca rage from mild to severe. If you are experiecig ay of these symptoms, talk with your doctor. Regular check ups ad testig ca help determie how your pulmoary surgical valve or coduit is workig. Leakig (Regurgitatio) The surgical valve or coduit does ot have a workig valve which causes blood to leak backward ito the right lower chamber of the heart (vetricle). This causes the heart to pump harder tha it should to brig blood to the lugs ad the rest of your body. Narrowig (Steosis) Leakig (Regurgitatio) 4

8 PULMONARY VALVE FAILURE TREATMENT OPTIONS Surgical Valve or Coduit Replacemet The stadard treatmet for arrowed or leakig pulmoary surgical valves or coduits has bee aother heart surgery to place a ew valve. Durig the surgery, your doctor removes your failig surgical valve or coduit ad places a ew surgical valve or coduit. Balloo Agioplasty/Valvuloplasty Durig this procedure, a thi, hollow tube (catheter) is iserted ito a vei (typically i your leg) ad guided to your heart. A deflated balloo is placed through the opeig of the arrowed surgical valve or coduit. Your doctor the iflates the balloo, which pushes the arrowed surgical valve or coduit ope so that blood may flow better. Trascatheter Pulmoary Valve Therapy A artificial heart valve attached to a wire, mesh-like tube (stet) is placed o a thi, flexible tube (catheter) with a balloo o the ed ad guided to the heart through a vei (usually at the top of the leg or a eck vei). It is put i the failed surgical valve or coduit. Oce i place, the balloo is iflated to ope up the valve ito positio. The catheter is removed from the body, ad the artificial heart valve becomes the ew pulmoary valve. 5

MELODY TRANSCATHETER PULMONARY VALVE (TPV) THERAPY The goal of Melody TPV Therapy is to restore pulmoary valve fuctio while delayig your ext ope-heart surgery as log as possible.

With Melody TPV Therapy, a thi, hollow tube (catheter) with a specially desiged heart valve iside is iserted ito a vei ad pushed up to your heart.

9 MELODY TRANSCATHETER PULMONARY VALVE (TPV) THERAPY The goal of Melody TPV Therapy is to restore pulmoary valve fuctio while delayig your ext ope-heart surgery as log as possible. About Melody TPV Therapy Melody TPV Therapy treats arrowed or leakig pulmoary surgical valves or coduits without opeheart surgery. With Melody TPV Therapy, a thi, hollow tube (catheter) with a specially desiged heart valve iside is iserted ito a vei ad pushed up to your heart. The heart valve is made from a cow s vei that has bee attached to a wire frame. Whe it is time for you to get the ew valve, it is placed oto a catheter ad guided through your vei to your heart where the ew valve will replace the old oe. Your ew valve will the be able to help your heart pump blood correctly. Melody TPV is a differet optio to take care of a failig pulmoary surgical valve or coduit i childre ad adults. Melody TPV Therapy does ot replace ope heart surgery but is meat to delay the eed for the ext surgery. Is Melody TPV Therapy Right For You? Melody TPV Therapy may be a optio for treatig your failig pulmoary valve. Whe Melody TPV Therapy Is Not A Optio There are o kow cotraidicatios for the Melody TPV. See Additioal Warigs ad Precautios sectio for coditios where safety of the Melody TPV has ot bee prove. Your heart doctor ca help you decide if Melody TPV Therapy may be right for you. 6

THE MELODY TPV PROCEDURE The followig sectio describes what happes durig the Melody TPV procedure. It is iteded as a geeral overview; your experiece may be differet.

Your doctor will isert the delivery system ito your vei (typically i your leg) through a small access site. 2.

10 THE MELODY TPV PROCEDURE The followig sectio describes what happes durig the Melody TPV procedure. It is iteded as a geeral overview; your experiece may be differet. Please talk to your doctor for more iformatio about what to expect. Durig The Procedure Typically, patiets are asleep uder aesthesia for the procedure ad usually do t feel ay pai. 1. Your doctor will isert the delivery system ito your vei (typically i your leg) through a small access site. 2. A thi, hollow tube (catheter) holdig the Melody valve will be placed ito the vei ad guided ito your heart. 3. Oce the Melody valve is i the right positio, the balloos will be iflated to deliver the valve. 4. The Melody valve will expad ito place ad begi to direct blood flow betwee the right lower chamber (vetricle) ad your lugs. 5. The catheter will the be removed ad the doctor will coduct a test to make sure the valve is workig properly. 6. The access site will be closed, ad the procedure will be complete. 7

11 After The Procedure After the Melody TPV procedure, you will go to a recovery room. Oce you are awake, you will be moved to a regular hospital room where you ll be able to eat ad drik. You likely will eed to stay i the hospital overight as most people go home the ext day. Your doctor will provide you with more specific care istructios as well as ay limitatios you may have. Usually, you ca retur to ormal activities i oe to two days. If you have ay questios, please ask your heart doctor or urse. Follow-up Care After your Melody TPV procedure, it is importat to follow your heart care team s istructios to esure the best possible results. Cotiue to take medicatios as prescribed Follow your daily care pla Keep appoitmets to have your heart ad Melody TPV checked Talk with your doctor if you have pai or other symptoms Iform your other doctors about your heart valve before ay medical procedure If you have a uexplaied, prologed fever, cotact your doctor to esure you do ot have a ifectio related to your heart valve Tell your detist that you have a artificial tissue valve. Durig detal work, bacteria may be released ito the bloodstream ad cause ifectio i ay tissue valve. This meas that you may eed to be o medicie (atibiotics) before ay detal procedure, eve routie cleaig Talk with your heart care team or urse if you have more questios about livig with your Melody valve. 8

12 RISKS YOU SHOULD KNOW What are the Potetial Risks Oe Year after Melody TPV Implatatio i a Surgical Valve? As with ay major medical procedure there is a risk of complicatios after the procedure to implat a Melody TPV ito a surgical valve. The major risks oe year after this procedure are as follows: Embolizatio of the TPV movemet of the valve from where it was implated Major Stet Fracture breakage of the wire frame (stet) that supports the tissue valve ad may lead to blockage of the valve Prosthetic Valve Edocarditis ifectio of the valve Valve Dysfuctio: Regurgitatio backward flow of blood through the valve Valve Dysfuctio: Steosis arrowig of the valve 9

The followig table summarizes the potetial risks oe year after Melody TPV implatatio i a surgical valve: Risk Embolizatio of TPV Major Stet Fracture Prosthetic Valve Edocarditis Valve

13 The followig table summarizes the potetial risks oe year after Melody TPV implatatio i a surgical valve: Risk Embolizatio of TPV Major Stet Fracture Prosthetic Valve Edocarditis Valve Dysfuctio: Regurgitatio Valve Dysfuctio: Steosis Oe year after Melody TPV implat 0 out of 100 patiets 0 out of 100 patiets 0 out of 100 patiets 1 out of 100 patiets 2 out of 100 patiets 10

14 RISKS YOU SHOULD KNOW What are the Potetial Risks Oe Year after Melody TPV Implatatio i a Coduit? As with ay major medical procedure there is a risk of complicatios after the procedure to implat a Melody TPV i a coduit. The major risks oe year after this procedure are as follows: Embolizatio of the TPV movemet of the valve from where it was implated Major Stet Fracture breakage of the wire frame (stet) that supports the tissue valve ad may lead to blockage of the valve Prosthetic Valve Edocarditis ifectio of the valve Valve Dysfuctio: Regurgitatio backward flow of blood through the valve Valve Dysfuctio: Steosis arrowig of the valve 11

The followig table summarizes the potetial risks oe year after Melody TPV implatatio i a coduit: Risk Embolizatio of TPV Major Stet Fracture Oe year after Melody TPV implat 0 out of 100 patiets

15 The followig table summarizes the potetial risks oe year after Melody TPV implatatio i a coduit: Risk Embolizatio of TPV Major Stet Fracture Oe year after Melody TPV implat 0 out of 100 patiets 9 out of 100 patiets Prosthetic Valve Edocarditis Valve Dysfuctio: Regurgitatio Valve Dysfuctio: Steosis table comig from cliical 3 out of 100 patiets 1 out of 100 patiets 4 out of 100 patiets 12

16 Other Possible Risks Associated with Melody TPV As with ay medical procedure, there is a risk of side effects or complicatios durig or after the Melody TPV procedure, which may be serious, icludig death. Complicatios that may occur durig or after this procedure iclude: Pai, swellig, ad bruisig at the site where the thi, hollow tube (catheter) etered your body Bleedig or pai at the site where the thi, hollow tube (catheter) etered your body Fever Reddeig, peelig, or blisterig of the ski due to x-rays Ifectio Irregular heart beat Tearig of the blood vessel where the thi, hollow tube (catheter) is iserted Tearig of a heart chamber or the pulmoary coduit Tearig of the coduit durig the procedure Squeezig of the arteries ear the failed coduit whe the stet or valve is expaded Developmet of a blood clot withi the valve which affects its fuctio or travels to the lug Movemet of the valve from where it was implated Breakdow of red blood cells Leakage of blood aroud the valve or valve frame Pokig a hole i a large blood vessel (perforatio) Allergic reactio to the x-ray dye Stroke (a coditio i which decreased blood flow to the brai causes brai cells to die) 13

$ope-heart surgery Importat Iformatio About Stet Fracture I some patiets, the wire frame (stet) of the Melody TPV may fracture because of the forces it is exposed to i your body.$

17 RISKS AND BENEFITS Melody TPV Therapy Beefits Restored pulmoary valve fuctio 1 Relief of arrowig (steosis) Relief of leakig (regurgitatio) Icreased pulmoary valve lifespa 1 Delay of a patiet s ext ope-heart surgery Importat Iformatio About Stet Fracture I some patiets, the wire frame (stet) of the Melody TPV may fracture because of the forces it is exposed to i your body. I some cases, the fractured stet may ot require additioal treatmet. However, you should realize a fractured stet has the potetial to become serious ad could result i the eed for aother procedure to replace your coduit. Your doctor will decide your best treatmet optio. There is up to a 3% chace that your Melody TPV stet will break withi oe year of placemet, requirig you to have aother procedure. For the complete data set, additioal iformatio ad Istructios for Use documetatio, cotact Medtroic LifeLie CardioVascular Techical Support at Melody Trascatheter Pulmoary Valve Cliical Report. Data o file. Medtroic, Ic. August

ADDITIONAL WARNINGS AND PRECAUTIONS Warigs The safety ad effectiveess of the Melody Trascatheter Pulmoary Valve (TPV) has oly bee established i patiets who have a arrowed or leaky pulmoary surgical

18 ADDITIONAL WARNINGS AND PRECAUTIONS Warigs The safety ad effectiveess of the Melody Trascatheter Pulmoary Valve (TPV) has oly bee established i patiets who have a arrowed or leaky pulmoary surgical valve or coduit. Precautios The safety ad effectiveess of the Melody Trascatheter Pulmoary Valve has ot bee prove i the followig: Patiets who have a disease of their aortic valve (valve that cotrols blood from the heart to the body) or mitral valve (valve that cotrols blood from the top left chamber of the heart to the bottom left chamber of the heart). The Melody TPV may ot work properly whe used i these locatios. Patiets whose blood vessels are ot big eough for the device Patiets who have a ifectio i the heart (edocarditis) or somewhere else i the body CAUTION: This device is restricted to sale by or o the order of a physicia. 15

19 FREQUENTLY ASKED QUESTIONS Are physical activities safe? Physical activities are safe for most patiets but you should talk with your heart doctor to decide what is best for you. Is it safe to have a x-ray with a Melody valve? It is completely safe to have a x-ray with a Melody valve. Is it safe to have a magetic heart sca (MRI) with a Melody valve? You may safely udergo MRI scaig uder specific coditios. If you eed a magetic resoace imagig (MRI) sca, tell your doctor or MRI techicia that you have a Melody valve or show your doctor your Melody implat card. Is it safe to go through airport security with a Melody valve? Yes. Airport security systems do ot affect Melody valves, ad the valve will ot set off airport alarms. How log will my Melody valve last? The legth of time that your Melody valve will last depeds o several factors icludig your uique aatomy ad health coditio. Some patiets may require aother procedure to restore fuctio of the valve. Procedures to restore fuctio of the Melody valve may iclude o-surgical procedures such as balloo agioplasty (iflatig a balloo to push the valve ope so that blood may flow better) or ope-heart surgery. The table below provides iformatio from Medtroic s cliical study, showig the umber of patiets who eeded aother procedure withi seve years after their Melody valve was implated. IDE Study (# of subjects) Three Years Post-Implat Five Years Post-Implat Seve Years Post-Implat No-Surgical Procedures 12 out of out of out of 100 Surgery 3 out of out of out of 100 IDE - Ivestigatioal Device Exemptio 16

20 RESOURCES Olie Resources Adult Cogeital Heart Associatio: America Heart Associatio: Childre s Heart Foudatio: Cogeital Heart Iformatio Network: Europea Cogeital Heart Disease Orgaizatio: The Iteratioal Society for Adult Cogeital Heart Disease: Melody TPV Therapy: Medtroic Parkway Mieapolis, MN USA Tel: (763) Fax: (763) Toll-free: 1 (800) (24-hour techical support for physicias ad medical professioals) LifeLie CardioVascular Techical Support Tel: (877) Tel: (763) Fax: (763) rs.cstechsupport@medtroic.com We re Here Whe You Need Us. Medtroic LifeLie Techical Support With more tha 60 years of experiece, Medtroic has a very kowledgeable staff who ca speak directly with you about o-medical questios you may have about your Melody valve. Please cotact us with ay questios or cocers about livig with your Melody valve. Medtroic LifeLie CardioVascular Techical Support Medtroic. All rights reserved. Medtroic, Medtroic logo ad Further, Together are trademarks of Medtroic. All other brads are trademarks of a Medtroic compay. UC b EN 02/2017

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