EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE (THV) 9600TFX (REF 9600TFX26A)Recalls & reported problems

Summary

The FDA's MAUDE database contains 733 adverse event reports that list this exact device (DI 00690103194357), received between Apr 29, 2019 and Jul 27, 2026 — classified as 22 deaths, 705 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Degraded” (194 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Jun 11, 2018Class IITerminated

   SAPIEN 3 THV was packaged with the incorrect valve size with respect to the label.

   Z-2435-2018 · Root cause: Labeling False and Misleading · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 733 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2026Degraded

  As reported by the Field Clinical Specialist (FCS), 6 years, 9 months, and 12 days post-implant of a 26 mm Sapien 3 valve in the aortic position, the 26 mm Sapien 3 valve required intervention due to stenosis, central regurgitation, and paravalvular leak (degeneration). The patient was experiencing heart failure. A valve in valve was completed successfully and the patient left the cath lab in stable condition.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 50036032 ↗
• InjuryJun 26, 2026Calcified

  IT WAS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), THAT APPROXIMATELY 6 YEARS, 7 MONTHS, 11 DAYS POST TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE WITH A 26 MM SAPIEN 3 VALVE, THE PATIENT UNDERWENT A SUCCESSFUL VALVE IN VALVE (VIV) PROCEDURE WITH A 26 MM SAPIEN 3 ULTRA VALVE DUE TO STENOSIS, MILD LEAFLET CALCIFICATION, AND MILD HYPOATTENUATED LEAFLET THICKENING (HALT) AT THE BASE OF ALL THREE LEAFLETS.

  Patient problems: Insufficient Information

  MAUDE report 25637771 ↗
• InjuryJun 25, 2026Perivalvular Leak

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), APPROXIMATELY 6 YEARS AND 11 MONTHS POST TRANSFEMORAL TAVR (TRANSCATHETER AORTIC VALVE REPLACEMENT) PROCEDURE WITH A 23MM SAPIEN 3 VALVE, THE VALVE FAILED DUE TO A SEVERE PARAVALVULAR LEAK (PVL). THE SAPIEN VALVE WAS BALLOONED WITH A 26MM NON-EDWARDS DEVICE TO RELIEVE SOME OF THE PVL, BUT THIS WAS UNSUCCESSFUL. IN RESPONSE, A SECOND VALVE (26MM SAPIEN 3 ULTRA) WAS IMPLANTED SLIGHTLY DEEPER VIA VALVE-IN-VALVE PROCEDURE, AFTER WHICH THE PVL REDUCED TO A MILD DEGREE. ADDITIONAL INFORMATION PROVIDED PER VALVE CLINICAL COORDINATOR INDICATING THERE WAS MILD PVL AT INITIAL TAVR IMPLANT. THE PATIENT SINCE PRESENTED WITH SHORTNESS OF BREATH AND A MEAN GRADIENT OF 6MMHG. THE FINAL PATIENT OUTCOME OF THE PATIENT IS REPORTED AS STABLE UPON DISCHARGE. ACCORDING TO THE PROVIDED MEDICAL RECORDS, TRANSTHORACIC ECHOCARDIOGRAM (TTE) PERFORMED 4 DAYS PRIOR TO REVISION NOTED A 26MM BIOPROSTHETIC VALVE THAT APPEARS WELL SEATED WITH NO ROCKING OR ABERRANT MOTION. WHILE THERE IS NO INTRAVALVULAR REGURGITATION, THERE IS MODERATE PERIVALVULAR REGURGITATION, THE MEAN SYSTOLIC GRADIENT IS 6MMHG, PEAK GRADIENT IS 9MMHG AND THE VALVE AREA IS 2.6CM^2.

  Patient problems: Dyspnea

  MAUDE report 25630573 ↗
• InjuryJun 25, 2026Calcified

  AS REPORTED FROM THE PARTNER 3 TRIAL, APPROXIMATELY 9 YEARS POST-IMPLANT OF A 26MM SAPIEN 3 VALVE IN THE AORTIC POSITION, THE VALVE IS FAILING DUE TO CALCIFICATION, AND VALVE INTERVENTION IS PLANNED. THE PATIENT UNDERWENT SUCCESSFUL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) WITH A 26MM SAPIEN S3 VALVE. APPROXIMATELY 7 MONTHS POST IMPLANT, VALVE-ASSOCIATED THROMBUS FORMATION WAS IDENTIFIED, PROMPTING INITIATION OF ANTICOAGULATION. APPROXIMATELY 7 YEARS AND 11 MONTHS POST-TAVR, THE PATIENT WAS ADMITTED DUE TO AN ISSUE UNRELATED TO THE VALVE. DURING THIS ADMISSION, A TRANSTHORACIC ECHOCARDIOGRAM (TTE) DEMONSTRATED A MEAN TRANSVALVULAR GRADIENT OF 28 MMHG AND AN AORTIC VALVE AREA (AVA) OF 1.63 CM2, WITH TRACE VALVULAR REGURGITATION AND NO PARAVALVULAR LEAK (PVL). NO IMMEDIATE INTERVENTION WAS PLANNED. APPROXIMATELY 8 YEARS AND 3 MONTHS POST-TAVR, THE PATIENT WAS BEING EVALUATED FOR PVL, BUT THE REGURGITATION WAS ONLY MILD TO MODERATE AND THERE WAS NO INDICATION FOR INTERVENTION. THE SURGEON'S INTERPRETATION OF THE ECHO DOCUMENTED MILD-TO-MODERATE PARAVALVULAR AORTIC REGURGITATION, ECCENTRIC AND DIRECTED TOWARDS THE ANTERIOR MITRAL LEAFLET. THE SURGEON ADDRESSED THE INCREASE IN GRAD

  Patient problems: Dyspnea; Heart Failure/Congestive Heart Failure

  MAUDE report 25628612 ↗
• InjuryJun 18, 2026Calcified

  AS REPORTED BY AN EDWARDS LIFESCIENCES FIELD CLINICAL SPECIALIST, APPROXIMATELY 7 YEARS AND 5 MONTHS POST IMPLANTATION OF A 26MM SAPIEN 3 VALVE IN THE AORTIC POSITION, CALCIFICATION AND STENOSIS WERE OBSERVED. A VALVE IN VALVE WAS PERFORMED. PATIENT SYMPTOMS BEFORE THE VALVE IN VALVE WAS NOT PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 25549289 ↗
• InjuryJun 11, 2026Degraded; Insufficient Device Problem Information

  AS REPORTED BY THE IMPLANT PATIENT REGISTRY TEAM, APPROXIMATELY (B)(6) POST SUCCESSFUL TRANSFEMORAL AORTIC VALVE REPLACEMENT WITH A 26MM SAPIEN 3 VALVE, THE VALVE WAS EXPLANTED AND REPLACED WITH A 25MM SURGICAL HEART VALVE. THE REASON FOR EXPLANT IS UNKNOWN AT THIS TIME.

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

  MAUDE report 25478310 ↗
• InjuryJun 1, 2026Device Stenosis

  AS REPORTED BY FIELD CLINICAL SPECIALIST (FCS), APPROXIMATELY 9 YEARS AND 8 MONTHS POST TRANSFEMORAL TAVR PROCEDURE WITH A 26MM SAPIEN 3 VALVE IN THE AORTIC POSITION, THE PATIENT UNDERWENT A VALVE IN VALVE DUE TO STENOSIS WITH A 23MM SAPIEN 3 ULTRA RESILIA VALVE. THE PATIENT IS STABLE.

  Patient problems: Insufficient Information

  MAUDE report 25350925 ↗
• InjuryJun 1, 2026Device Stenosis

  AS REPORTED BY A FIELD CLINICAL SPECIALIST, APPROXIMATELY 10 YEARS POST TAVR WITH A 26MM SAPIEN 3 VALVE, THE VALVE FAILED DUE TO AORTIC STENOSIS. THE PATIENT IS BEING EVALUATED FOR A SECOND VALVE.

  Patient problems: Insufficient Information

  MAUDE report 25349702 ↗
• InjuryMay 29, 2026Insufficient Device Problem Information

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), APPROXIMATELY 6 YEARS AND 5 MONTHS POST TRANSFEMORAL TAVR (TRANSCATHETER AORTIC VALVE REPLACEMENT) PROCEDURE WITH A 26MM SAPIEN 3 VALVE IN THE NATIVE AORTIC POSITION, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE REPLACEMENT. ADDITIONAL INFORMATION PROVIDED PER FCS INDICATING THE PATIENT IS SCHEDULED FOR VALVE-IN-VALVE INTERVENTION. ADDITIONAL INFORMATION PROVIDED PER FCS CONFIRMING THAT THE PATIENT UNDERWENT A SUCCESSFUL VALVE-IN-VALVE PROCEDURE WITH A 26MM SAPIEN 3 ULTRA RESILIA VALVE. THE LAST KNOWN PATIENT STATUS IS REPORTED AS ALIVE AND IN RECOVERY.

  Patient problems: Insufficient Information

  MAUDE report 25337832 ↗
• InjuryMay 28, 2026Degraded

  PER THE FIELD CLINICAL SPECIALIST, APPROXIMATELY SIX YEARS AND EIGHT MONTHS POST TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) IMPLANT USING A 26MM SAPIEN 3 VALVE, THE VALVE IS FAILING DUE TO HYPO ATTENUATED LEAFLET THICKENING (HALT). THE PATIENT UNDERWENT A VALVE IN VALVE PROCEDURE USING A 23MM SAPIEN 3 ULTRA RESILIA VALVE.

  Patient problems: Insufficient Information

  MAUDE report 25322834 ↗
• InjuryMay 26, 2026Device Stenosis

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST, APPROXIMATELY 6 YEARS AND 6 MONTHS POST TRANSFEMORAL TAVR PROCEDURE WITH A 26MM SAPIEN 3 VALVE IN THE AORTIC POSITION, THE PATIENT UNDERWENT A VIV DUE TO STENOSIS.

  Patient problems: Insufficient Information

  MAUDE report 25280625 ↗
• InjuryMay 20, 2026Device Stenosis

  AS REPORTED BY A FIELD CLINICAL SPECIALIST, APPROXIMATELY 8 YEARS AND 6 MONTHS POST TAVR WITH A 26MM SAPIEN 3 VALVE, THE VALVE FAILED DUE TO STENOSIS. AS A RESULT, A 23MM SAPIEN 3 ULTRA RESILIA VALVE WAS IMPLANTED IN A VALVE IN VALVE PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 25233244 ↗
• InjuryMay 19, 2026Degraded

  AS REPORTED BY A FIELD CLINICAL SPECIALIST (FCS), APPROXIMATELY 6 YEARS AND 6 MONTHS POST-IMPLANT OF A 26 MM SAPIEN 3 VALVE IN THE AORTIC POSITION VIA TRANSFEMORAL APPROACH, THE VALVE FAILED. THE FAILURE MODE IS UNKNOWN. ADDITIONAL INFORMATION WAS RECEIVED THAT THE VALVE WAS EXPLANTED AND A 23 MM INSPIRIS RESILIA WAS IMPLANTED. ACCORDING TO THE MEDICAL RECORDS, THE OPERATIVE NOTE FROM THE PATIENT'S INITIAL TAVR PROCEDURE, THE 26MM SAPIEN 3 VALVE WAS DEPLOYED WITHOUT COMPLICATIONS AND ECHO DID NOT REVEAL ANY PARAVALVULAR LEAK (PVL) AND PRESSURE GRADIENT WAS LESS THAN 5MMHG. THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 25224699 ↗
• InjuryMay 18, 2026Device Stenosis

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST, APPROXIMATELY 7 YEARS AND 8 MONTHS POST TAVR WITH A 26MM SAPIEN 3 VALVE IN THE AORTIC POSITION, THE PATIENT UNDERWENT A TRANSCATHETER HEART VALVE (THV) VALVE'IN'VALVE PROCEDURE DUE TO STENOSIS. A PROCTOR REVIEW WAS ASSOCIATED WITH THE CASE. THE PATIENT WAS A 76'YEAR'OLD FEMALE WHO WAS SYMPTOMATIC PRIOR TO INTERVENTION, REPORTING FATIGUE AND HEART FAILURE SYMPTOMS. THE PATIENT'S FINAL OUTCOME FOLLOWING THE VALVE'IN'VALVE PROCEDURE WAS REPORTED AS STABLE CONDITION, AND THE PATIENT WAS ALIVE AT THE END OF THE PROCEDURE. THE INDICATION FOR THE VALVE'IN'VALVE PROCEDURE WAS STENOSIS OF THE PREVIOUSLY IMPLANTED TRANSCATHETER VALVE. PRIOR TO THE INTERVENTION, REPORTED HEMODYNAMIC PARAMETERS INCLUDED A MEAN GRADIENT OF APPROXIMATELY 40 MMHG, PEAK VELOCITY OF 4.3 M/S, AND AN AORTIC VALVE AREA OF APPROXIMATELY 0.93 CM', CONSISTENT WITH RESTENOSIS. THE FAILED VALVE WAS IDENTIFIED AS A SAPIEN 3 TRANSCATHETER HEART VALVE, WITH THE FAILURE MODE REPORTED AS STENOSIS. THE VALVE'IN'VALVE PROCEDURE WAS PERFORMED VIA TRANSFEMORAL ACCESS USING THE RIGHT SIDE, WITH IMPLANTATION IN THE AORTIC POSITION. A 23 MM SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE WAS IMPL

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 25211167 ↗
• InjuryMay 18, 2026Device Stenosis

  AS REPORTED BY EDWARDS LIFESCIENCES FIELD CLINICAL SPECIALIST, 5 YEARS AND 4 MONTHS POST IMPLANTATION OF A 26MM SAPIEN 3 VALVE IN THE AORTIC POSITION, A VALVE IN VALVE WITH A 23MM SAPIEN 3 ULTRA RESILIA VALVE DUE TO STENOSIS. PATIENT SYMPTOMS BEFORE VALVE IN VALVE WERE NOT PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 25209711 ↗
• InjuryMay 18, 2026Degraded

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST, APPROXIMATELY 6 YEARS AND 9 MONTHS POST TRANSFEMORAL TAVR PROCEDURE WITH A 26 MM SAPIEN 3 VALVE, THE PATIENT PRESENTED TO THE HOSPITAL WITH A SHORTNESS OF BREATH AND HEART FAILURE. THE MOST RECENT ECHO DURING THE HOSPITAL ADMISSION SHOWED A VALVE AREA OF 1.1 CM2, A PEAK VELOCITY OF 3.6 M/S, A MEAN GRADIENT OF 30.0 MMHG, A DIMENSIONLESS INDEX OF 0.32, AND AN EJECTION FRACTION ESTIMATED AT 14%. CARDIAC CATHETERIZATION REVEALED A VALVE AREA OF 1.0 CM2. WITH THE PATIENT'S SYMPTOMS AND ECHO THE TEAM FEELS THE AORTIC STENOSIS IS SEVERE.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 25202003 ↗
• InjuryMay 18, 2026Calcified

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), 6 YEARS, 7 MONTHS, AND 12 DAYS POST-IMPLANT OF A 26 MM SAPIEN 3 VALVE IN THE AORTIC POSITION, THE 26 MM SAPIEN 3 VALVE REQUIRED INTERVENTION DUE TO STENOSIS (VALVE AREA < 0.5CM2) AND CALCIFICATION WITH A GRADIENT OF OVER 50MMHG. THE PATIENT WAS EXPERIENCING FATIGUE AND HEART FAILURE. A VALVE IN VALVE WAS COMPLETED SUCCESSFULLY WITH POST DILATION OF THE SECOND VALVE THE HELP EXPAND THE FRAME AND THE PATIENT WAS IN STABLE CONDITION. ACCORDING TO THE MEDICAL RECORDS, A CLINIC NOTE WAS PROVIDED FOR PRE-OP TRANSCATHETER AORTIC VALVE REPLACEMENT EVALUATION (TAVR). THE PATIENT WAS EXPERIENCING ANGINA, SHORTNESS OF BREATH WITH EVERYDAY ACTIVITIES, PROGRESSIVE FATIGUE, AND DIZZINESS. A TRANSTHORACIC ECHOCARDIOGRAPHY (TTE) SHOWED THE 26MM SAPIEN VALVE WITH CALCIFICATION OF THE LEAFLETS AND REDUCED OPENING VISUALLY, NO VALVULAR OR PARAVALVULAR INSUFFICIENCY, MEAN GRADIENT 43MMHG, AND VALVE AREA INDEX CALCULATES AT 0.49CM2 PER M2 SUGGESTING SEVERE AORTIC STENOSIS WAS PRESENT. THE RIGHT HEART CATHETERIZATION SHOWED THE VALVE AREA OF 0.7'0.8CM2, WHICH WAS CONSISTENT WITH SEVERE AORTIC STENOSIS OF THE PROSTHESIS. AFTER PRE-OP WORKUP, THE PLAN WA

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 25201676 ↗
• InjuryMay 15, 2026Calcified

  PER THE FIELD CLINICAL SPECIALIST, APPROXIMATELY SIX YEARS AND FIVE MONTHS POST TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) IMPLANT USING A 23MM SAPIEN 3 VALVE, THE PATIENT NOW PRESENTS WITH AORTIC STENOSIS. FOLLOW UP FROM THE FCS INDICATED THAT THE CASE HAS BEEN WORKED UP AND THE COMMISSURE POST ARE IN FRONT OF THE LEFT AND RIGHT OSTIA OF THE CORONARIES. ACCORDING TO THE MEDICAL RECORD THIS PATIENT WAS EXPERIENCING EXERTIONAL BREATHLESSNESS, AS NOTED IN A CARDIOLOGY FOLLOW UP VISIT. THE SIX YEAR TRANSTHORACIC ECHOCARDIOGRAM (TTE) WAS PERFORMED AND NOTED THE BIOPROSTHETIC TAVR VALVE LEAFLETS ARE CALCIFIED AND SEVERELY STENOSED, WITH A MEAN GRADIENT OF 53 MM HG AND A PEAK GRADIENT OF 86 MM HG, YIELDING A SEVERELY REDUCED VALVE AREA OF 0.55 CM2. WHEN COMPARED WITH THE PREVIOUS STUDY, THE TAVR VALVE HAS BECOME MORE SEVERELY STENOTIC AND SHOULD UNDERGO A PROMPT VALVE IN VALVE NEW TAVR REPLACEMENT. THE PATIENT WAS SEEN IN CONSULT WITH STRUCTURAL HEART THE FOLLOWING DAY. A CARDIAC COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) WAS PERFORMED AND NOTED THE TAVR FRAME APPEARS TO BE VERY CLOSE TO CORONARY ARTERIES WHICH IS CONCERNING FOR OCCLUSION WITH VALVE IN VALVE (VIV) TAVR. THE PATIENTS 23MM S

  Patient problems: Dyspnea

  MAUDE report 25186717 ↗
• InjuryMay 14, 2026Calcified; Insufficient Device Problem Information

  IT WAS REPORTED VIA THE IMPLANT PATIENT REGISTRY THAT APPROXIMATELY 8 YEARS AND 10 MONTHS FOLLOWING A TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE TO IMPLANT A 26 MM SAPIEN 3 VALVE, A VALVE IN VALVE PROCEDURE WAS PERFORMED.

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

  MAUDE report 25176123 ↗
• InjuryMay 14, 2026Device Stenosis

  PER THE FIELD CLINICAL SPECIALIST, APPROXIMATELY SIX YEARS AND FOUR MONTHS POST TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE USING A 26MM SAPIEN 3 VALVE, THE VALVE WAS EXPLANTED DUE TO SEVERE AORTIC STENOSIS.

  Patient problems: Insufficient Information

  MAUDE report 25167026 ↗
• InjuryMay 14, 2026Calcified; Perivalvular Leak

  AS REPORTED BY AN EDWARDS LIFESCIENCES FIELD CLINICAL SPECIALIST, A 26MM SAPIEN 3 VALVE FAILED AFTER AN IMPLANT DURATION OF 9 YEARS AND 6 MONTHS. THE PATIENT PRESENTED WITH DYSPNEA ON EXERTION, WALKING LESS THAN 1 BLOCK, AND FATIGUE. THE VALVE HAD MILD-MODERATE PERIVALVULAR LEAK AND MILD TRANSVALVULAR AORTIC INSUFFICIENCY. THE VALVE PEAK AND MEAN GRADIENT WAS 88MMHG AND 52MMHG, RESPECTIVELY. AN ADDITIONAL FAILURE MODE OF THE VALVE WAS STENOSIS, AND THE AORTIC VALVE AREA MEASURED 0.7CM2. THE PERCEIVED ROOT CAUSE OF THE VALVE DYSFUNCTION WAS UNKNOWN BY THE REPORTER. A VALVE-IN-VALVE WAS SUCCESSFULLY PERFORMED WITH A 26MM SAPIEN 3 ULTRA RESILIA VALVE. PER REVIEW OF THE CT PRIOR TO VALVE-IN-VALVE BY AN EDWARDS LIFESCIENCES CLINICAL IMAGER, 26MM SAPIEN 3 VALVE IS EXPANDED TO APPROXIMATELY 86% OF NOMINAL (24.1 MM AT THE WAIST). THERE IS SEVERE SAPIEN 3 VALVE LEAFLET CALCIFICATION. THE VALVE POSITION IS APPROPRIATE AT THE LEFT AND RIGHT CUSPS; HOWEVER, IT SITS HIGH AT THE NON-CORONARY CUSP (100:0; AORTIC: VENTRICULAR). THIS COULD BE A CONTRIBUTOR TO THE PARAVALVULAR LEAK, HOWEVER, IT IS UNABLE TO BE CONFIRMED.

  Patient problems: Dyspnea; Fatigue

  MAUDE report 25166944 ↗
• InjuryMay 11, 2026Degraded; Fluid/Blood Leak

  AS REPORTED BY AN EDWARDS LIFESCIENCES FIELD CLINICAL SPECIALIST, APPROXIMATELY 7 YEARS AND 5 MONTHS POST IMPLANTATION OF A 26MM SAPIEN 3 VALVE IN THE AORTIC POSITION, A VALVE IN VALVE WITH A 23MM SAPIEN 3 ULTRA RESILIA VALVE WAS PERFORMED SUCCESSFULLY DUE TO STENOSIS, MODERATE REGURGITATION, AND PVL. THE PVL OF THE ORIGINAL THV WAS STILL PRESENT. THE IC PROCEEDED TO PLUG THE PVL. PATIENT SYMPTOMS BEFORE THE VALVE IN VALVE WERE NOT PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 25142442 ↗
• InjuryMay 6, 2026Calcified

  AS REPORTED BY AN EDWARDS LIFESCIENCES FIELD CLINICAL SPECIALIST, A 26MM SAPIEN 3 VALVE, IMPLANTED WITHIN A PREEXISTING SURGICAL VALVE IN THE AORTIC POSITION, REQUIRED VALVE-IN-VALVE REINTERVENTION AFTER AN IMPLANT DURATION OF 8 YEARS AND 7 MONTHS. FAILURE MODE WAS IDENTIFIED AS REGURGITATION. PER THE MEDICAL RECORD RECEIVED, THE VALVE-IN-VALVE OPERATIVE REPORT DOCUMENTED PEAK AND MEAN TRANSVALVULAR GRADIENTS OF 64 MMHG AND 55 MMHG, RESPECTIVELY, WITH 3-4+ AORTIC REGURGITATION. THE REGURGITATION WAS NOT QUALIFIED AS CENTRAL AORTIC INSUFFICIENCY OR PARAVALVULAR LEAK. PER REVIEW BY AN EDWARDS LIFESCIENCES CLINICAL IMAGER, THE CT SHOWS THAT THE 26 MM VALVE IS EXPANDED TO 23.4 MM AT THE MID-VALVE LEVEL, WHICH CORRESPONDS TO APPROXIMATELY 80% OF NOMINAL EXPANSION. THERE IS EXTENSIVE CALCIFICATION AND LEAFLET THICKENING OF THE SAPIEN 3 VALVE. THE PATIENT UNDERWENT A SUCCESSFUL VALVE-IN-VALVE PROCEDURE USING A 26MM SAPIEN 3 ULTRA RESILIA VALVE.

  Patient problems: Insufficient Information

  MAUDE report 25106814 ↗
• InjuryMay 4, 2026Device Stenosis

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), APPROXIMATELY 6 YEARS POST TAVR WITH A 23MM SAPIEN 3 VALVE IN THE AORTIC POSITION, THE PATIENT IS BEING EVALUATED FOR THV IN THV, FAILURE MODE UNKNOWN. UPON FOLLOW UP, THE FCS ADVISED THAT THE PATIENT UNDERWENT A VIV WITH AN EVOLUT VALVE DUE TO STENOSIS. THE PATIENT WAS STABLE AFTER PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 25073711 ↗
• InjuryApr 29, 2026Calcified

  AS REPORTED BY IMPLANT PATIENT REGISTRY, APPROXIMATELY 7 YEARS AND 9 MONTHS POST TRANSFEMORAL TAVR PROCEDURE WITH A 26MM SAPIEN 3 VALVE IN THE AORTIC POSITION THE VALVE WAS EXPLANTED DUE TO UNKNOWN REASONS. AFTER REVIEWING THE MEDICAL RECORDS PROVIDED, THE PATIENT IS A 65-YEAR-OLD FEMALE, WITH A PAST MEDICAL HISTORY SIGNIFICANT FOR SEVERE AORTIC STENOSIS, HEART FAILURE WITH PRESERVED EJECTION FRACTION, ATRIAL SEPTAL DEFECT STATUS POST REPAIR VIA LEFT THORACOTOMY IN 1961, ASCENDING AORTIC ANEURYSM MEASURING 4.7 CM, HYPERTENSION, HYPERLIPIDEMIA, DIABETES MELLITUS TYPE 2, HYPOTHYROIDISM, CHRONIC KIDNEY DISEASE STAGE II, NEPHROTIC SYNDROME, ASTHMA, OBSTRUCTIVE SLEEP APNEA, MORBID OBESITY STATUS POST LAPAROSCOPIC SLEEVE GASTRECTOMY IN 2021, LEFT BREAST DUCTAL CARCINOMA IN SITU STATUS POST LUMPECTOMY IN 2015, TRANSIENT ISCHEMIC ATTACK IN 2007, PRIOR CHOLECYSTECTOMY, DEPRESSION, THROMBOCYTOPENIA, IRON DEFICIENCY ANEMIA, RAYNAUD'S DISEASE, CHRONIC LYME DISEASE, RESTLESS LEG SYNDROME, AND GASTROESOPHAGEAL REFLUX DISEASE. THE PATIENT UNDERWENT IMPLANTATION OF A 26 MM EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE IN THE AORTIC POSITION ON (B)(6) 2018. APPROXIMATELY 7 YEARS AND 9 MONTHS POST IMPL

  Patient problems: Chest Pain

  MAUDE report 25033233 ↗