EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE (THV) 9600TFX (REF 9600TFX20A)Recalls & reported problems

Summary

The FDA's MAUDE database contains 154 adverse event reports that list this exact device (DI 00690103194005), received between Feb 12, 2021 and May 21, 2026 — classified as 2 deaths, 150 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Degraded” (39 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 154 reports, in the reporter's own words as published by the FDA.

• InjuryMay 21, 2026Degraded

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST, A PATIENT WITH A 20 MM SAPIEN 3 IN PULMONARY HOMOGRAFT IMPLANTED FOR 7 YEARS AND 6 MONTHS PRESENTED WITH MODERATE TO SEVERE PULMONARY STENOSIS WITH MILD REGURGITATION. THE PATIENT UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER 7 YEARS AND 9 MONTHS. HE WAS SYMPTOMATIC WITH FATIGUE AND HEART FAILURE. A 23 MM SAPIEN 3 VALVE WAS SUCCESSFULLY IMPLANTED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Insufficient Information

  MAUDE report 25250250 ↗
• InjuryMay 15, 2026Degraded

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), APPROXIMATELY 9 YEARS, 6 MONTHS, 5 DAYS POST TRANSFEMORAL TAVR PROCEDURE WITH A 20MM SAPIEN 3 VALVE, THE VALVE PRESENTED SEVERE STENOSIS. THE PATIENT UNDERWENT A SUCCESSFUL VALVE IN VALVE PROCEDURE WITH A 20MM SAPIEN 3 ULTRA RESILIA VALVE. PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT WAS FATIGUE WITH SYNCOPE. THE PEAK/MEAN GRADIENT'S WERE 62/36 MMHG. THE LEAFLETS WERE THICKENED AND STENOTIC. THE PATIENT WAS DISCHARGED.

  Patient problems: Fatigue

  MAUDE report 25191864 ↗
• InjuryMar 30, 2026Degraded

  PER ADDITIONAL INFORMATION PROVIDED, THE SURGICAL DATE IS PLANNED.

  Patient problems: Dyspnea; Insufficient Information

  MAUDE report 24735715 ↗
• InjuryMar 11, 2026Calcified

  AS REPORTED BY AN EDWARDS LIFESCIENCES JAPAN AFFILIATE, APPROXIMATELY 6 YEARS AND 3 MONTHS POST TRANSFEMORAL TAVR (TRANSCATHETER AORTIC VALVE REPLACEMENT) PROCEDURE WITH A 20MM SAPIEN 3 VALVE IN THE NATIVE AORTIC POSITION, THE VALVE FAILED DUE TO STENOSIS AND MODERATE-TO-SEVERE CENTRAL REGURGITATION. PER REPORT, THE PATIENT PRESENTED WITH UNKNOWN SYMPTOMS AND THE PERCEIVED ROOT CAUSE OF THE STENOSIS IS CALCIFICATION. THE PATIENT UNDERWENT A SUCCESSFUL VALVE-IN-VALVE PROCEDURE WITH A 20MM SAPIEN 3 ULTRA VALVE AND WAS IN STABLE CONDITION. THE FOLLOWING DAY, THE PATIENT WAS DISCHARGED.

  Patient problems: Insufficient Information

  MAUDE report 24569512 ↗
• InjuryMar 6, 2026Degraded; Perivalvular Leak

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST, APPROXIMATELY 7 YEARS POST-TRANSFEMORAL TAVR PROCEDURE WITH A 20 MM SAPIEN 3 VALVE IMPLANTED IN AN 80/20 POSITION, THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH WORSENING CHEST PAIN, EPIGASTRIC PAIN, AND FATIGUE. A VALVE-IN-VALVE (VIV) WORKUP WAS REQUESTED. THE PATIENT RETURNED FROM A HEPATOBILIARY IMINODIACETIC ACID SCAN WITH AGONAL BREATHING AND HYPOTENSION. THEY WERE A NO CODE, AND THEIR FAMILY WAS AT THEIR BEDSIDE. A VIV PROCEDURE WAS NOT PERFORMED BECAUSE THE PATIENT EXPIRED SHORTLY THEREAFTER. OUTSIDE OF THIS EVENT, THE PATIENT ALSO HAD ACTIVE INFECTION WITH POSITIVE BLOOD CULTURES. THE ADMISSION ECHO SHOWED AN EJECTION FRACTION OF 20-25%. THERE WAS A WELL SEATED TAVR 20 MM VALVE IN THE AORTIC POSITION. THE MEAN TRANS-VALVULAR GRADIENT MEASURED 61 MMHG. THE PEAK GRADIENT WAS 5.08 M/S, AND THERE WAS MODERATE PARAVALVULAR REGURGITATION. THE AORTIC VALVE PEAK AND MEAN GRADIENTS WERE 99/61 MMHG, AND THE AORTIC VALVE AREA CALCULATED USING THE VELOCITY-TIME INTEGRAL WAS 0.49 CM2. THE PATIENT HAD AN ECHO THAT SHOWED PARAVALVULAR LEAK, INCREASED GRADIENT AND STENOSIS. THE INITIAL REPORTER DID NOT ALLEGE THAT ANY OF THE EDWARD'S DEVICES WE

  Patient problems: Chest Pain; Fatigue

  MAUDE report 24536736 ↗
• InjuryFeb 23, 2026Perivalvular Leak

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), PRIOR TO INTERVENTION THE FCS BECAME AWARE OF AN EVENT INVOLVING AN 83'YEAR'OLD FEMALE PATIENT WITH A HISTORY OF SEVERE SYMPTOMATIC AORTIC STENOSIS PREVIOUSLY TREATED WITH A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) IN (B)(6) 2016. THE PATIENT SUBSEQUENTLY DEVELOPED COMPLETE HEART BLOCK FOLLOWING THE INDEX PROCEDURE, REQUIRING DUAL'CHAMBER PACEMAKER PLACEMENT. THE PATIENT ALSO DEVELOPED MODERATE TO SEVERE PARAVALVULAR REGURGITATION (PVL) AFTER THE ORIGINAL IMPLANT. MULTIPLE INTERVENTIONS WERE ATTEMPTED TO ADDRESS THE PERSISTENT PVL. A PARAVALVULAR LEAK CLOSURE PROCEDURE WAS ATTEMPTED IN 2017 BUT WAS UNSUCCESSFUL. LATER IN 2017, A BALLOON AORTIC VALVULOPLASTY WAS PERFORMED TO IMPROVE VALVE APPOSITION TO THE ANNULUS; HOWEVER, THE PVL CONTINUED TO PERSIST DESPITE THESE EFFORTS. THESE DETAILS WERE REPORTED BASED ON INFORMATION PROVIDED BY AN OUTSIDE PHYSICIAN IN AUGUST OF A PRIOR YEAR. APPROXIMATELY 9 YEARS AND 4 MONTHS POST TAVR, THE PERSISTENT PVL WAS TREATED WITH A 20MM SAPIEN 3 ULTRA VALVE. THE PATIENT REMAINED IN STABLE CONDITION.

  Patient problems: Insufficient Information

  MAUDE report 24420337 ↗
• InjuryFeb 9, 2026Degraded; Difficult to Open or Close; Device Stenosis

  AS REPORTED BY A FIELD CLINICAL SPECIALIST (FCS), APPROXIMATELY 1 YEAR AND 9 MONTHS POST-IMPLANT OF A 20 MM SAPIEN 3 IN A NON-EW VALVE IN THE MITRAL POSITION VIA TRANSFEMORAL APPROACH, THE PATIENT PRESENTED WITH HEART FAILED AND THE VALVE FAILED DUE TO STENOSIS. THE MEAN/PEAK GRADIENT IS 20-35 MMHG. INITIAL 20 MM SAPIEN 3 VALVE FROM 2024 WAS BELIEVED TO BE A BIT UNDER-EXPANDED. THE TEAM PRE-DILATED THE EXISTING 20 MM SAPIEN 3 VALVE WITH AN 18MM NON-EW BALLOON AT 20ATM BEFORE IMPLANTING THE NEW 20 MM SAPIEN 3 VALVE. POST IMPLANT, THE TEAM ESTIMATED THE NEW 20 MM SAPIEN 3 VALVE MEASURED ABOUT 19MM SO THE IMPLANTING TEAM HOPE THIS ONE LASTS LONGER. ACCORDING TO THE MEDICAL RECORDS, THE SUMMARY SHOWED SEVERE MITRAL STENOSIS WITH NO SIGNIFICANT REGURGITATION, THE APICAL ASPECT OF THE SAPIEN VALVE EXTENDS INTO THE LEFT VENTRICULAR OUTFLOW TRACT WITHOUT OBVIOUS LEFT VENTRICULAR OUTFLOW TRACT OBSTRUCTION. THE MEAN MITRAL INFLOW GRADIENT IS 20-27MMHG. THE LIMITED EVALUATION WITHIN THE SAPIEN VALVE SUGGESTS REDUCED MOBILITY OF THE LEAFLETS CONTRIBUTES TO STENOSIS. ALSO, ECHOGENIC THICKENING ON THE ATRIAL ASPECT OF THE LEAFLETS IS PROBABLY PRESENT. LVOT OBSTRUCTION WAS RULED OUT.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 24291796 ↗
• InjuryJan 28, 2026Calcified

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), 2 YEARS, 7 MONTHS, AND 3 DAYS POST-IMPLANT OF A 20 MM SAPIEN 3 (S3) VALVE IN THE MITRAL POSITION WITHIN A PREVIOUSLY IMPLANTED MELODY VALVE, THE 20 MM SAPIEN 3 VALVE FAILED DUE TO STENOSIS AND CALCIFICATION. THE MEAN/ PEAK GRADIENT WAS BETWEEN 20-35MMHG AND THE PATIENT WAS EXPERIENCING HEART FAILURE. THE MOST RECENT ECHO SHOWED SEVERE BIOPROSTHETIC MITRAL VALVE STENOSIS AND SIGNIFICANT MITRAL REGURGITATION. THE MITRAL MEAN GRADIENT WAS 24-26MM HG AT 96-97 BEATS PER MINUTE AND THE VALVE LEAFLETS WERE THICK WITH SIGNIFICANTLY DECREASED MOBILITY. A VALVE IN VALVE WAS COMPLETED SUCCESSFULLY USING ANOTHER 20MM SAPIEN 3 VALVE. IT'S NOTED THAT THE MELODY VALVE WAS SURGICALLY SEWN INTO THE PATIENT WHEN THE PATIENT WAS 3 MONTHS OLD. THE TEAM SAID THEY DID NOT PRE-DILATE THE MELODY BEFORE THE INITIAL S3 AND ONLY GOT IT TO ABOUT 16MM. THIS SECOND S3 WAS PRE-DILATED WITH AN 18MM ATLAS GOLD BALLOON AT HIGH PRESSURE AND EXPANDED THE LANDING ZONE. AFTER THE 2ND S3 WAS IMPLANTED, THE DIAMETER OF THE VALVE WAS MEASURED, AND IT WAS APPROXIMATELY 18MM. THE TEAM WAS HAPPY WITH THE OUTCOME AND THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 24200488 ↗
• InjuryJan 19, 2026Gradient Increase

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), APPROXIMATELY 1 YEAR POST TAVR WITH A 20MM SAPIEN 3 VALVE IN THE PULMONIC POSITION, A PATIENT, WHO HAD A HISTORY OF PREVIOUS ENDOCARDITIS UNDERWENT A POST DILATION DUE TO STENOSIS, WITH PRE-INTERVENTION MEAN/PEAK GRADIENTS BETWEEN 20'35 MMHG. THE MOST RECENT FOLLOW-UP ECHOCARDIOGRAM AND PROGRESS NOTES WERE NOT AVAILABLE. THE PATIENT'S SYMPTOMATIC STATUS PRIOR TO INTERVENTION IS UNKNOWN, AND IT IS ANTICIPATED THAT THIS INFORMATION WILL BE OBTAINED. DURING THE PROCEDURE, THE PHYSICIAN PERFORMED BALLOON VALVULOPLASTY ON THE PREVIOUSLY IMPLANTED SAPIEN VALVE. A SECOND VALVE WAS NOT IMPLANTED. THE MOST RECENT VALVE AREA/INDEX AND POST-INTERVENTION GRADIENT MEASUREMENTS ARE UNKNOWN. NO FOLLOW-UP ECHOCARDIOGRAPHIC DATA WERE AVAILABLE AT THE TIME OF REPORTING. UPON FOLLOW UP, THE FCS ADVISED THAT THE PATIENT SYMPTOMATIC STATUS PRIOR TO INTERVENTION (ANTICIPATED TO BE OBTAINED) AND WAS HOSPITALIZED WITH ENDOCARDITIS. IMPLANT ACCESS AND ACCESS SITE -IJ AND THE MEAN GRADIENT AFTER INTERVENTION 5MMHG.

  Patient problems: Insufficient Information

  MAUDE report 24109563 ↗
• InjuryNov 28, 2025Degraded; Degraded

  ACCORDING TO THE FIELD CLINICAL SPECIALIST (FCS), APPROXIMATELY SIX YEARS AND THREE MONTHS AFTER TRANSCATHETER PULMONIC VALVE REPLACEMENT (TPVR), USING A 20MM SAPIEN 3 VALVE, PRESENTED WITH PULMONARY STENOSIS (PS) AND PULMONARY REGURGITATION (PR) ACROSS THE 20 MM SAPIEN VALVE. THE PATIENT WAS TREATED WITH BALLOON VALVULOPLASTY USING A 20 MM NON-EDWARDS BALLOON, FOLLOWED BY IMPLANTATION OF A NEW 20 MM NON-EDWARDS VALVE. POST-PROCEDURE, THE TRANSVALVULAR GRADIENT WAS REDUCED TO 2 MMHG, WITH NO EVIDENCE OF PULMONARY REGURGITATION OR INSUFFICIENCY.

  Patient problems: Insufficient Information

  MAUDE report 23673979 ↗
• InjuryNov 6, 2025Device Stenosis; Device Stenosis

  AS REPORTED BY A FIELD CLINICAL SPECIALIST, A PATIENT UNDERWENT A TRANSFEMORAL TAVR PROCEDURE WITH A 20MM SAPIEN 3 VALVE IN AORTIC POSITION. APPROXIMATELY 6 YEARS AND 11 MONTHS LATER, THE PATIENT PRESENTED WITH SYMPTOMS OF DYSPNEA AND HEART FAILURE, AND WAS FOUND TO HAVE STENOSIS OF THE PREVIOUSLY IMPLANTED THV. PRE-INTERVENTION ECHOCARDIOGRAPHIC FINDINGS INCLUDED A MEAN/PEAK GRADIENT GREATER THAN 50MMHG AND A VALVE AREA BETWEEN 0.5 AND 1.0 CM2. A VALVE-IN-VALVE PROCEDURE WAS PERFORMED USING A 20MM EDWARDS SAPIEN 3 ULTRA RESILIA VALVE, WHICH WAS SUCCESSFULLY IMPLANTED VIA RIGHT TRANSFEMORAL ACCESS IN THE AORTIC POSITION. THE PATIENT REMAINED IN STABLE CONDITION FOLLOWING THE PROCEDURE.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 23488013 ↗
• InjuryOct 27, 2025Calcified; Calcified

  AS REPORTED BY AN EDWARDS LIFESCIENCES FIELD CLINICAL SPECIALIST, A 20MM SAPIEN 3 VALVE HAS LEAFLET DEGENERATION APPROXIMATELY 7 YEARS POST IMPLANT IN THE AORTIC POSITION. THE VALVE HAD SEVERE STENOSIS, MODERATE REGURGITATION, RESTRICTED LEAFLET MOTION, AND CALCIFICATION WAS OBSERVED ON THE LEAFLETS. THE PATIENT WAS SYMPTOMATIC WITH DYSPNEA AND HEART FAILURE. THE VALVE WAS TREATED WITH A VALVE-IN-VALVE PROCEDURE WITH A NON-EW VALVE.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 23398602 ↗
• InjurySep 17, 2025Intravalvular regurgitation; Intravalvular regurgitation

  AS REPORTED BY A FIELD CLINICAL SPECIALIST, A PATIENT UNDERWENT A TRANSFEMORAL PULMONIC PROCEDURE WITH A 20MM SAPIEN 3 VALVE INSIDE A PRE-EXISTING NON-EDWARDS FAILING 21MM SURGICAL VALVE. DURING THE PROCEDURE, AN 18MM NON-EDWARDS BALLOON WAS INFLATED TO RESOLVE THE INITIAL STENOSIS OF THE PRE-EXISTING NON-EDWARDS VALVE. A STENT GRAFT WAS IMPLANTED ON THE 20MM VIV MEASURING 15MM AT WAIST. THE PHYSICIAN POST DILATED WITH A 20MM NON-EDWARDS BALLOON. THE 20MM SAPIEN 3 VALVE WAS THEN IMPLANTED WITH +2CC 50/50 AT THE SURGICAL VALVE RADIOPAQUE MARKER. THE WAIST MEASURED 16.9, GRADIENT MEASURED 8MMHG AND THERE WAS NO LEAK. THE PHYSICIAN WAS UNCOMFORTABLE WITH THE UNDER-EXPANDED WAIST AND THEREFORE POST-DILATED WITH A 22X4 BALLOON TO 18 ATM IN ATTEMPT TO FRACTURE THE SURGICAL VALVE. THIS WAS UNSUCCESSFUL AND POST ANGIO REVEALED CENTRAL REGURGITATION OF THE SAPIEN 3 VALVE. A 24X4 NON-EDWARDS BALLOON WAS THEN DILATED TO FURTHER STRETCH BUT UNABLE TO CONFIRM FRACTURE OF THE SURGICAL VALVE. IT WAS THEN DECIDED TO DEPLOY A 23MM SAPIEN 3 VALVE WITHIN THE FRAME OF ORIGINAL SAPIEN 3 VALVE. THE POST GRADIENT MEASURED 8MMHG AND NO REGURGITATION WAS NOTED. POST ICE IMAGING HOWEVER DEMONSTRATED LEAFLET

  Patient problems: Insufficient Information

  MAUDE report 23074161 ↗
• DeathAug 28, 2025Device Stenosis; Device Stenosis

  AS REPORTED BY THE FIELD SPECIALIST, APPROXIMATELY 7 YEARS, 1 MONTH, AND 24 DAYS POST TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE WITH A 20 MM SAPIEN 3 VALVE, THE PATIENT WAS IN THE INTENSIVE CARE UNIT (ICU) WITH CLASS IV HEART FAILURE DUE TO STENOSIS. ADDITIONAL INFORMATION WAS PROVIDED INDICATING THE PATIENT WAS IN CARDIOGENIC SHOCK WITH BILATERAL PULMONARY EMBOLISMS. A DECISION WAS MADE TO PLACE THE PATIENT ON PALLIATIVE CARE. SUBSEQUENTLY, THE PATIENT PASSED AWAY.

  Patient problems: Cardiogenic Shock

  MAUDE report 22916461 ↗
• InjuryAug 26, 2025Calcified; Calcified

  AS REPORTED BY A FIELD CLINICAL SPECIALIST (FCS), APPROXIMATELY 6 YEARS TAVR PROCEDURE WITH A 20MM SAPIEN 3 VALVE IN THE AORTIC POSITION, THE PATIENT PRESENTS WITH A FAILING SAPIEN 3 VALVE. THE MODE OF FAILURE IS AORTIC STENOSIS. THERE IS PLAN FOR INTERVENTION (THV-IN-THV), BUT NO SCHEDULED PROCEDURE DATE AT THIS TIME. THE PATIENT IS STILL BEING WORKED UP. UPON FOLLOW UP, THE FCS ADVISED THAT THE PATIENT PRESENTS WITH MILD TO MODERATE VALVULAR REGURGITATION, MODERATE TO SEVERE STENOSIS, AND GRADE 1'2 HYPOATTENUATED LEAFLET THICKENING (HALT), WITH RESTRICTED LEAFLET MOTION NOTED. ECHOCARDIOGRAPHIC FINDINGS REVEAL A PEAK GRADIENT OF 60 MMHG, A MEAN GRADIENT OF 35 MMHG, AND A VALVE AREA OF 0.76 CM', INDICATING SIGNIFICANT HEMODYNAMIC COMPROMISE. THE PATIENT IS CURRENTLY UNDERGOING FURTHER EVALUATION AND HAS NOT YET RECEIVED ANY INTERVENTION. SYMPTOMS INCLUDE SHORTNESS OF BREATH AND CHEST PAIN. RELEVANT MEDICAL HISTORY AND THE MOST RECENT FOLLOW-UP ECHOCARDIOGRAM AND PROGRESS NOTES ARE REFERENCED IN THE ATTACHED DOCUMENTATION. THE PATIENT'S CONDITION IS STILL UNDER ASSESSMENT, AND NO FINAL OUTCOME HAS BEEN DETERMINED AT THIS TIME. UPON REVIEW OF MEDICAL RECORDS RECEIVED, A TTE DATED (B

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 22895731 ↗
• InjuryAug 15, 2025Degraded; Device Stenosis; Degraded; Device Stenosis

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST, APPROXIMATELY 8 YEARS POST TRANSFEMORAL TAVR PROCEDURE WITH A 20 MM SAPIEN 3 (S3) VALVE, THE VALVE IS FAILING DUE TO STENOSIS. THE PATIENT RECEIVED A 20MM SAPEIN 3 ULTRA RESILIA VALVE INSIDE THE 20 MM S3 VALVE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Heart Failure/Congestive Heart Failure; Insufficient Information

  MAUDE report 22821911 ↗
• InjuryJul 30, 2025Calcified; Calcified

  AS REPORTED BY A FIELD CLINICAL SPECIALIST, APPROXIMATELY 7 YEARS AND 3 MONTHS POST TAVR WITH A 20MM SAPIEN 3 VALVE, THE VALVE WAS FAILING DUE TO STENOSIS, REGURGITATION, CALCIFICATION AND DEGENERATION. THE PATIENT WAS IS SYMPTOMATIC WITH FATIGUE. A THV IN THV IS PLANNED.

  Patient problems: Fatigue

  MAUDE report 22666461 ↗
• InjuryJul 29, 2025Calcified; Calcified

  AS REPORTED FROM FIELD CLINICAL SPECIALIST, A PATIENT UNDERWENT A TRANSFEMORAL TAVR PROCEDURE WITH A 20MM SAPIEN 3 VALVE IN AORTIC POSITION. APPROXIMATELY 8 YEARS AND 10 MONTHS LATER, THE PATIENT PRESENTED WITH A FAILED VALVE DUE TO CALCIFICATION AND STENOSIS. THE PATIENT UNDERWENT A VALVE IN VALVE WITH A 20MM SAIEN 3 ULTRA RESILIA VALVE INSIDE THE PRE-EXISTING 20MM SAPIEN 3 VALVE.

  Patient problems: Insufficient Information

  MAUDE report 22649713 ↗
• InjuryJul 22, 2025Degraded; Degraded

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), APPROXIMATELY 6 YEARS AND 1 MONTH POST TRANSFEMORAL TAVR (TRANSCATHETER AORTIC VALVE REPLACEMENT) PROCEDURE WITH A 20MM SAPIEN 3 VALVE IN THE NATIVE AORTIC POSITION, THE VALVE FAILED DUE TO STENOSIS WITH THE AORTIC VALVE AREA MEASURING 0.79CM^2. AN INCREASED GRADIENT OF 41MMHG WAS ALSO NOTED WITH ABNORMAL LEAFLET(S). PER REPORT, THE PATIENT PRESENTED WITH SHORTNESS OF BREATH AND HEART FAILURE. THE PATIENT UNDERWENT A SUCCESSFUL VALVE-IN-VALVE PROCEDURE WITH A 20MM SAPIEN 3 ULTRA VALVE AND WAS DISCHARGED.

  Patient problems: Insufficient Information

  MAUDE report 22566375 ↗
• InjuryJul 14, 2025Calcified; Fluid/Blood Leak; Device Stenosis; Calcified; Fluid/Blood Leak; Device Stenosis

  AS REPORTED BY AN EDWARDS LIFESCIENCES FIELD CLINICAL SPECIALIST, APPROXIMATELY 4 YEARS AND 8 MONTHS POST IMPLANTATION OF A 20MM SAPIEN 3 VALVE IN THE PULMONIC POSITION, A VALVE IN VALVE WITH A 20MM SAPIEN 3 ULTRA RESILIA VALVE WAS SUCCESSFULLY PERFORMED DUE TO REGURGITATION AND STENOSIS. PATIENT SYMPTOMS WERE NOT PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 22502826 ↗
• InjuryJul 8, 2025Degraded; Degraded

  AS REPORTED BY AN EDWARDS LIFESCIENCES FIELD CLINICAL SPECIALIST, APPROXIMATELY 9 YEARS AND 2 MONTHS POST IMPLANTATION OF A 20MM SAPIEN 3 VALVE IN THE AORTIC POSITION, A VALVE IN VALE WITH A 20MM SAPIEN 3 ULTRA RESILIA VALE WAS PERFORMED DUE TO STENOSIS AND REGURGITATION. THE PROCEDURE WAS SUCCESSFUL.

  Patient problems: Insufficient Information

  MAUDE report 22437574 ↗
• InjuryMay 30, 2025Fluid/Blood Leak; Difficult to Open or Close; Fluid/Blood Leak; Difficult to Open or Close

  AS REPORTED BY A FIELD CLINICAL SPECIALIST (FCS), DURING A TMVR PROCEDURE WITH A 20MM SAPIEN 3 VALVE, THE VALVE HAD MILD TO MODERATE MITRAL REGURGITATION (MR) POST-IMPLANT. THE IC DECIDED TO POST-DILATE WHICH UNFORTUNATELY MADE THE MR WORSE, SO MADE THE DECISION TO RE-VALVE THIS PATIENT'S MITRAL VALVE. A SECOND 20MM SAPIEN LOOKED GREAT WITH NO LEAK AND 2MMHG GRADIENT. PER ADDITIONAL INFORMATION PROVIDED BY THE FCS, IT IS UNKNOWN WHETHER THE REGURGITATION WAS PVL OR CENTRAL. ''THERE COULD HAVE BEEN A BIT OF ''FROZEN LEAFLET'' HAPPENING, WHICH WAS THE CAUSE FOR THE LEAK.'' THE FCS INDICATED THE ROOT CAUSE COULD BE DUE TO A ''SMALL VALVE, PERHAPS UNDER DEPLOYED.'' THE PATIENT HAD MODERATE ANNULAR CALCIFICATION WITH A 17MM MINIMUM LUMINAL DIAMETER.

  Patient problems: Insufficient Information

  MAUDE report 22115781 ↗
• InjuryMay 19, 2025Calcified; Insufficient Device Problem Information; Calcified; Insufficient Device Problem Information

  IT WAS REPORTED BY THE EDWARDS LIFESCIENCES IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 20MM SAPIEN 3 TRANSCATHETER VALVE, IMPLANTED IN THE AORTIC POSITION, UNDERWENT AN EXPLANT PROCEDURE AFTER AN IMPLANT DURATION OF 7 YEARS AND 11 MONTHS DUE TO UNKNOWN REASONS. A SURGICAL VALVE WAS IMPLANTED. NO ADDITIONAL DETAILS WERE PROVIDED.

  Patient problems: Dyspnea; Fatigue; Insufficient Information

  MAUDE report 22045314 ↗
• InjuryMay 14, 2025Degraded; Thickening of Material; Device Stenosis; Degraded; Thickening of Material; Device Stenosis

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), APPROXIMATELY 3 YEARS, 2 MONTHS, AND 23 DAYS POST-IMPLANT OF A 20 MM SAPIEN 3 (S3) VALVE IN THE MITRAL POSITION, THE 20 MM SAPIEN 3 VALVE WAS NOTED TO BE STENOTIC. THE MEAN INFLOW GRADIENTS WERE BETWEEN 12-15MMG. DUE TO THE PATIENT'S HISTORY, THIS WAS FOUND ON A ROUTINE EXAM WHICH THE ECHO REVEALED BI-ATRIAL ENLARGEMENT ALSO. DURING THE VALVE IN VALVE CASE, THE IMPLANTING CARDIOLOGIST (IC) AND TEAM HAD DIFFICULTY POSITIONING THE NEW 20MM S3 INSIDE OF THE EXISTING 20MM S3. IT APPEARED THAT THE IC COULD NOT GET IT COAXIAL ENOUGH TO FULLY CROSS AND POSITION APPROPRIATELY AND WHEN PUSHING ON THE COMMANDER DELIVERY SYSTEM, AT ONE POINT, THE VALVE APPEARED TO 'JUMP' FORWARD INTO THE LEFT VENTRICLE (LV). THE WORKING WIRE (SAFARI EXTRA SMALL) MAY HAVE JUMPED FORWARD ALSO. THE TEAM PULLED THE NEW S3 VALVE BACK, NEARLY TO AN ACCEPTABLE POSITION TO DEPLOY, BUT THEN IT MOVED TOO ATRIAL. THEY CONTINUED TO STRUGGLE TO CROSS THE EXISTING VALVES (THE PREVIOUS 20MM S3 WAS ALREADY INSIDE OF A 23MM EPIC SUPRA THAT WAS PLACED IN 2018). SOMEWHERE NEAR THIS POINT IN TIME WE NOTICED THE PATIENT'S BLOOD PRESSURE BEGAN TO DECLINE. THE HEART RHYTHM CHANGED

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 22022484 ↗
• InjuryMay 5, 2025Perivalvular Leak; Perivalvular Leak

  AS REPORTED BY AN EDWARDS LIFESCIENCES FIELD CLINICAL SPECIALIST (FCS), APPROXIMATELY 5 YEARS AND 8 MONTHS POST IMPLANTATION OF A 20MM SAPIEN 3 VALVE IN THE AORTIC POSITION PVL WAS OBSERVED. PATIENT PRESENTED IN OFFICE WITH DYSPNEA SYMPTOMS. IN OFFICE TTE SHOWED THE PATIENT HAD MILD TO MODERATE PVL. PHYSICIAN TRIED TO PLUG THE PV LEAK. PLUG WAS UNABLE TO CROSS AND WAS NOT PLACED. PHYSICIAN DILATED WITH 20MM TRUE BALLOON TO TRY AND SEAL LEAK. THIS CREATED CENTRAL LEAK. PHYSICIAN THEN DECIDED TO PLACE A NEW 20MM SAPIEN 3 ULTRA RESILIA VALVE INSIDE THE ORIGINAL TAVR VALVE. THIS SEALED THE ORIGINAL PVL AND CENTRAL LEAK. THE PATIENT WAS NOT HARMED AND THE VALVE WAS PLACED SUCCESSFULLY. MILD TO MODERATE PARAVALULAR LEAK WAS OBSERVED AT INITIAL IMPLANT. PER THE FCS, UNDER DEPLOYED VALVE WAS THE POTENTIAL ROOT CAUSE OF THE EVENTS.

  Patient problems: Dyspnea

  MAUDE report 21962983 ↗