EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE (THV) 9600TFX (REF 9600TFX23A)Recalls & reported problems

Summary

The FDA's MAUDE database contains 975 adverse event reports that list this exact device (DI 00690103194340), received between May 3, 2019 and Jul 31, 2026 — classified as 14 deaths, 960 injuries, 1 malfunction.

The most frequently reported specific device problem is “Degraded” (331 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 975 reports, in the reporter's own words as published by the FDA.

• InjuryJul 31, 2026Degraded

  As reported by the Field Clinical Specialist (FCS), 7 years, 7 months, and 23 days post-implant of a 23 mm Sapien 3 valve in the aortic position, the 23 mm Sapien 3 valve required intervention due to stenosis, paravalvular leak (PVL), and increased gradients. The mean/ peak gradient was noted to be between 35-50mmHg and the AVA was between 0.5-1.0 cm2. The patient was experiencing dyspnea and heart failure. A valve in valve (VIV) procedure was completed with +2cc of volume successfully. Following the VIV, there was no PVL and the mean gradient was 5mmHg. The patient was in stable condition.

  Patient problems: Dyspnea; Heart Failure/Congestive Heart Failure

  MAUDE report 50104767 ↗
• InjuryJun 25, 2026Device Stenosis

  EDWARDS RECEIVED NOTIFICATION FROM A FIELD CLINICAL SPECIALIST THAT DURING A PATIENT WITH A 23MM SAPIEN 3 VALVE, IMPLANTED IN THE AORTIC POSITION, UNDERWENT A VALVE IN VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 9 YEARS AND 6 MONTHS DUE TO STENOSIS. A 23MM SAPIEN 3 ULTRA VALVE WAS IMPLANTED SUCCESSFULLY. THERE WERE NO DEVICE OR PROCEDURAL COMPLICATIONS.

  Patient problems: Insufficient Information

  MAUDE report 25630863 ↗
• InjuryJun 24, 2026Calcified

  AS REPORTED BY IMPLANT PATIENT REGISTRY, A PATIENT UNDERWENT EXPLANT OF THEIR 23MM SAPIEN 3 VALVE IN THE AORTIC POSITION APPROXIMATELY 9 YEARS AND 1.5 MONTHS POST TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. THE DEVICE WAS EXPLANTED AND REPLACED WITH AN EDWARDS SURGICAL VALVE. ACCORDING TO THE MEDICAL RECORD REVIEW, THE PATIENT WAS EXPERIENCING SEVERE EXERTIONAL SHORTNESS OF BREATH, LETHARGY, DIZZINESS, LIGHTHEADEDNESS AND BILATERAL LOWER EXTREMITY EDEMA. AN OPERATIVE REPORT WAS NOT PROVIDED, HOWEVER A POST OPERATIVE FOLLOW UP NOTE INDICATED THAT THE PATIENT UNDERWENT TAVR EXPLANT, AORTIC ROOT REPLACEMENT, PULMONARY VEIN ISOLATION (PVI) AND LEFT ATRIAL APPENDAGE LIGATION. THE PATIENT WAS NOTED TO BE A POOR VALVE IN VALVE CANDIDATE DUE TO ANATOMY AND RISK FOR CORONARY ARTERY OBSTRUCTION. THE CONSULTATION NOTES INDICATED THAT THE PATIENT HAD SEVERE STENOSIS WITH KNOWN PATIENT PROSTHETIC MISMATCH. A CTA TAVR NOTED THE VALVE IS GROSSLY INTACT, THERE IS MILD HALT OF ALL 3 LEAFLETS, NO PERIVALVULAR LEAK. A TEE PERFORMED APPROXIMATELY 9 YEARS AND 1 MONTH POST IMPLANT NOTED A TAVR VALVE WITHOUT SIGNIFICANT STENOSIS AND NORMAL LEAFLET OPENING. THE PATHOLOGY REPORT NOTED A MEDICA

  Patient problems: Dyspnea

  MAUDE report 25609737 ↗
• InjuryJun 22, 2026Gradient Increase

  THE FIELD CLINICAL SPECIALIST (FCS), CALLED INTO THE THV HOTLINE TO REPORT THE PATIENT'S BAV PROCEDURE PERFORMED TO ADDRESS POTENTIAL INCREASED GRADIENTS. THE TRANSTHORACIC ECHOCARDIOGRAM (TTE) INDICATED ELEVATED GRADIENTS; HOWEVER, ACCURATE MEASUREMENTS COULD NOT BE OBTAINED. THE PHYSICIAN PERFORMED A POST-DILATION OF THE PREVIOUSLY IMPLANTED 23 MM SAPIEN 3 VALVE APPROXIMATELY 9 YEARS AND 3 MONTHS POST TAVR. NO PATIENT SYMPTOMS WERE REPORTED, AND THE PATIENT WAS NOTED TO BE DOING WELL POST-PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 25584480 ↗
• InjuryJun 22, 2026Calcified

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS) APPROXIMATELY 5 YEARS, 9 MONTHS, AND 22 DAYS POST TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT WITH A 23MM SPAIEN 3 VALVE THE VALVE HAD TO BE EXPLANTED DUE TO STRUCTURAL VALVE DETERIORATION AND A SURGICAL VALVE WAS IMPLANTED. THE PATIENT PRESENTED WITH DYSPNEA AND FATIGUE. THE PATIENT HAD A PEAK GRADIENT OF 124 AND A MEAN GRADIENT OF 82, THE VALVE INDEX AREA WAS 0.64. THE LEAFLETS WERE FOUND TO BE THICKENED; THE LEFT CORONARY CUSP WAS MILDLY RESTRICTED AND THE OTHER 2 LEAFLETS WERE SIGNIFICANTLY RESTRICTED. THE PATIENT IS STILL IN THE HOSPITAL POST EXPLANT. PER MEDICAL RECORDS THE PATIENT PRESENTED WITH SEVERE STENOSIS AND PERIVALVULAR INSUFFICIENCY. UNDER GENERAL ANESTHESIA, THE PATIENT HAD TAVR EXPLANT AND AVR. PER IMAGERY REVIEW BY EDWARDS IMAGER THE VALVE LEAFLETS APPEAR SOMEWHAT THICKENED AND MARKEDLY ELEVATED CALCIUM BURDEN, PARTICULARLY INVOLVING TWO OF THE PROSTHETIC LEAFLETS, WITH FEATURES CONSISTENT WITH CALCIFIED NODULES.

  Patient problems: Dyspnea

  MAUDE report 25577039 ↗
• InjuryJun 15, 2026Device Stenosis

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), APPROXIMATELY 7 YEARS AND 8 MONTHS POST TAVR WITH A 23MM SAPIEN 3 VALVE IN THE MITRAL POSITION, THE PATIENT UNDERWENT A VIV DUE TO STENOSIS. A 23MM SAPIEN 3 ULTRA RESILIA VALVE WAS IMPLANTED WITHIN THE EXISTING THV. CATH GRADIENT POST IMPLANT WAS 2MMHG AND ECHO GRADIENT WAS 5MMHG.

  Patient problems: Insufficient Information

  MAUDE report 25506750 ↗
• InjuryJun 11, 2026Calcified

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS) APPROXIMATELY 6 YEARS AND 3 MONTHS POST TRANSCATHETER AORTIC VALVE REPLACEMENT WITH A 23MM SAPIEN 3 VALVE THE VALVE FAILED DUE TO STENOSIS. THE MEAN VALVE GRADIENT WAS 55MMHG. THERE IS NO ADDITIONAL INFORMATION AT THIS TIME. THE PATIENT PRESENTED WITH DIZZINESS. MEDICAL RECORDS WERE RECEIVED AND REVIEWED BY AN EDWARDS CLINICIAN; THE CT REVEALED THERE WERE CALCIFIED AORTIC VALVE LEAFLETS. THE STRUCTURAL HEART CARDIOLOGY NOTE STATED THAT THE PLAN WAS TO SEND TO ''VENDORS'' TO REVIEW RISK FOR VALVE IN VALVE TAVR AND POTENTIAL NEED FOR LEAFLET MODIFICATION AT TIME OF TAVR. THE VALVE IN VALVE PROCEDURE IS TO BE SCHEDULED FOR (B)(6) 2026.

  Patient problems: Dizziness

  MAUDE report 25470508 ↗
• InjuryJun 8, 2026Degraded

  AS REPORTED TO THE IMPLANT PATIENT REGISTRY (IPR), 8 YEARS, 6 MONTHS, AND 16 DAYS POST-IMPLANT OF A 23 MM SAPIEN 3 VALVE IN THE AORTIC POSITION, THE 23 MM SAPIEN 3 VALVE WAS EXPLANTED, AND A SURGICAL VALVE WAS IMPLANTED. THE REASON FOR EXPLANT IS DEGENERATION. ACCORDING TO THE MEDICAL RECORDS, THE PATIENT UNDERWENT A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) EXPLANT AND AN AORTIC VALVE REPLACEMENT (AVR) WITH A 23MM INSPIRIS VALVE AND AN ASCENDING AORTIC REPLACEMENT WITH A 26MM NON EDWARDS GRAFT. THE PATIENT TOLERATED THE PROCEDURE WELL. THE PROCEDURE WAS INDICATED DUE TO SEVERE SYMPTOMATIC AORTIC STENOSIS AND STRUCTURAL VALVE DETERIORATION OF THE TAVR VALVE. THE INTRAOPERATIVE TEE SHOWED MEAN GRADIENT OF 53.5MMHG, MARKED SCLEROCALCIFICATION OF THE AORTIC VALVE LEAFLETS, MILD AORTIC VALVE REGURGITATION, WELL-POSITIONED PROSTHETIC VALVE WITH NO PARAVALVULAR LEAK, LEAFLET EXCURSION IS SEVERELY LIMITED.

  Patient problems: Insufficient Information

  MAUDE report 25435914 ↗
• InjuryJun 8, 2026Calcified

  AS REPORTED BY IMPLANT PATIENT REGISTRY, A PATIENT UNDERWENT EXPLANT OF THEIR 23MM SAPIEN 3 VALVE IN THE AORTIC POSITION APPROXIMATELY 9 YEARS AND 4 MONTHS POST TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. THE DEVICE WAS EXPLANTED AND REPLACED WITH AN EDWARDS SURGICAL VALVE. ACCORDING TO THE MEDICAL RECORD REVIEW, THIS PATIENT WAS ADMITTED FOR ACUTE ON CHRONIC HEART FAILURE EXACERBATION AND WAS DIURESED FOR VOLUME OVERLOAD. TTE SHOWED THICKENED AND CALCIFIED LEAFLETS, SEVERE AORTIC STENOSIS (VALVE AREA OF 0.5CM2) , MEAN GRADIENT OF 47MMHG, AND SEVERE MITRAL REGURGITATION. THE PATIENT UNDERWENT A REDO STERNOTOMY AVR AND MVR.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 25429991 ↗
• InjuryJun 8, 2026Degraded

  AS REPORTED BY THE PARTNER 3 VALVE IN VALVE (P3A) CLINICAL STUDY, A PATIENT UNDERWENT A TRANSFEMORAL TAVR PROCEDURE WITH A 23MM SAPIEN 3 VALVE INSIDE A PRE-EXISTING EDWARDS SURGICAL PERIMOUNT VALVE IN AORTIC POSITION. APPROXIMATELY 7 YEARS AND 10 MONTHS LATER, THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH SEVERE WORSENING OF SHORTNESS OF BREATH. AN ECHO SHOWED AVA 0.3, MEAN GRADIENT 97MMHG, AND PEAK VELOCITY OF 621CM/SEC. THERE WAS NOTE OF SEVERE CENTRAL AORTIC REGURGITATION AS WELL. THE PATIENT UNDERWENT EXPLANT OF THE VALVE WITH SAVR. ACCORDING TO THE MEDICAL RECORD REVIEW, THE PATIENT HAD EXPERIENCED WORSENING DYSPNEA AND BILATERAL LOWER EXTREMITY EDEMA FOR SEVERAL MONTHS. THE SYMPTOMS WORSENED 4 DAYS PRIOR TO ADMISSION, ECHOCARDIOGRAM REVEALED SEVERE AORTIC STENOSIS AND REDUCED EJECTION FRACTION. THE PATIENT DEVELOPED ACUTE HYPOXIC RESPIRATORY FAILURE, PULMONARY EDEMA AND HEMATURIA. THE PATIENT WAS MANAGED WITH DIURETICS, STEROIDS, AND INHALATION THERAPY. CARDIOLOGY RECOMMENDED URGENT EVALUATION FOR REDO SAVR. ONE WEEK POST ADMISSION THE PATIENT UNDERWENT REDO AORTIC VALVE REPLACEMENT AND WAS DISCHARGED 6 DAYS LATER.

  Patient problems: Dyspnea

  MAUDE report 25428414 ↗
• InjuryJun 2, 2026Degraded; Insufficient Device Problem Information

  AS REPORTED BY IMPLANT PATIENT REGISTRY, APPROXIMATELY SIX YEARS AND SEVEN MONTHS POST IMPLANTATION OF A 23MM SAPIEN 3 VALVE IN THE AORTIC POSITION, THE DEVICE WAS EXPLANTED AND REPLACED WITH A SURGICAL VALVE. THE REASON FOR THE VALVE EXPLANTATION IS UNKNOWN AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 25364580 ↗
• InjuryJun 2, 2026Degraded

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST, APPROXIMATELY 8 YEARS AND 6 MONTHS AFTER INITIAL IMPLANT OF A 23 MM SAPIEN 3 ULTRA VALVE VIA TRANSCATHETER VALVE REPLACEMENT INTO THE AORTIC POSITION BY TRANSFEMORAL APPROACH, THE PATIENT PRESENTED WITH SHORTNESS OF BREATH, AND THE VALVE EXHIBITED STENOSIS AND ELEVATED GRADIENTS. A VALVE IN VALVE PROCEDURE WAS PERFORMED WITH A 20 MM SAPIEN 3 ULTRA RESILIA VALVE.

  Patient problems: Dyspnea

  MAUDE report 25363474 ↗
• InjuryMay 27, 2026Calcified

  AS REPORTED BY AN EDWARDS LIFESCIENCES FIELD CLINICAL SPECIALIST, A 23MM SAPIEN 3 VALVE, IMPLANTED IN THE AORTIC POSITION, REQUIRED REINTERVENTION AFTER AN IMPLANT DURATION OF 6 YEARS AND 4 MONTHS. THE FAILURE MODES WERE IDENTIFIED AS STENOSIS, MILD CENTRAL REGURGITATION, AND CALCIFICATION. MEAN/PEAK VALVE GRADIENTS WERE ABOVE 50MMHG. THE PATIENT WAS SYMPTOMATIC WITH WHEEZING, SHORTNESS OF BREATH, ATYPICAL CHEST PAIN, AND ACUTE PULMONARY EDEMA. A VALVE-IN-VALVE PROCEDURE WAS PERFORMED WITH A 23MM SAPIEN 3 ULTRA RESILIA VALVE. THE VALVE WAS SUCCESSFULLY DEPLOYED. POST PROCEDURE MEAN GRADIENT MEASURED 6MMHG, WITH NO PARAVALVULAR LEAK OR AORTIC INSUFFICIENCY. THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: Chest Pain; Dyspnea; Pulmonary Edema; Wheezing

  MAUDE report 25303460 ↗
• InjuryMay 26, 2026Device Stenosis

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST, APPROXIMATELY 8 YEARS AND 10 MONTHS POST TAVR WITH A 23 MM SAPIEN 3 VALVE IN THE AORTIC POSITION, A PATIENT PRESENTED WITH A FAILED VALVE. THE THV IN THV WAS PERFORMED DUE TO STENOSIS. UPON FOLLOW UP, THE VCC ADVISED THAT THE PATIENT WAS REPORTED TO BE SYMPTOMATIC PRIOR TO THE INTERVENTION, WITH WORSENING SHORTNESS OF BREATH AND FATIGUE OVER THE PAST YEAR, RESULTING IN DECREASED ENERGY AND THE NEED FOR ASSISTANCE WITH DAILY ACTIVITIES. THE PATIENT ALSO REPORTED AN APPROXIMATE 40-POUND WEIGHT GAIN, GENERALIZED ACHES, AND OCCASIONAL BRIEF EPISODES OF SHARP CHEST PAIN OCCURRING PRIMARILY AT NIGHT. RELEVANT MEDICAL HISTORY INCLUDED TYPE 2 DIABETES MELLITUS (DM2). THE PATIENT'S CONDITION WAS REPORTED AS STABLE FOLLOWING THE PROCEDURE AND THE PATIENT WAS DISCHARGED ON POSTOPERATIVE DAY 1.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 25279005 ↗
• InjuryMay 21, 2026Degraded

  IT WAS INITIALLY REPORTED BY IMPLANT PATIENT REGISTRY THROUGH RECEIPT OF AN IMPLANT DATA CARD, THAT APPROXIMATELY 6 YEARS, 4 MONTHS, 10 DAYS POST TRANSFEMORAL TAVR PROCEDURE WITH A 23MM SAPIEN 3 VALVE, THE PATIENT'S VALVE WAS EXPLANTED AND REPLACED WITH A SURGICAL VALVE. PER MEDICAL RECORDS PROVIDED, THE VALVE WAS EXPLANTED DUE TO STRUCTURAL VALVE DEGENERATION ASSOCIATED WITH BOTH AORTIC STENOSIS AND AORTIC REGURGITATION. A TRANSTHORACIC ECHOCARDIOGRAM PERFORMED DEMONSTRATED THICKENED AORTIC VALVE LEAFLETS WITH RESTRICTED MOTION AND ELEVATED GRADIENTS FOR THE AORTIC PROSTHESIS, INCLUDING A MEAN GRADIENT OF 46.0 MMHG. THE AORTIC VALVE AREA BY CONTINUITY EQUATION USING THE INDEXED DIAMETER WAS 0.60 CM2, AORTIC VALVE AREA BY VELOCITY DERIVED METHOD WAS 0.59 CM2, AORTIC VALVE PROSTHETIC EFFECTIVE ORIFICE AREA WAS 0.61 CM2, AND DOPPLER VELOCITY INDEX WAS 0.30, ALL CONFIRMING SEVERE STENOSIS. ADDITIONALLY, CENTRAL AORTIC REGURGITATION WAS OBSERVED AND APPEARED SEVERE. DURING THE VALVE EXPLANTATION PROCEDURE, EXTENSIVE FUNGATING CALCIFICATION OF THE ASCENDING AORTA WAS IDENTIFIED, WITH THE ASCENDING AORTA NOTED TO BE SHORT AND SEVERELY CALCIFIED ALONG THE LESSER CURVATURE, NECESSITATING S

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 25248756 ↗
• InjuryMay 20, 2026Calcified

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), APPROXIMATELY 6 YEARS POST TRANSFEMORAL TAVR (TRANSCATHETER AORTIC VALVE REPLACEMENT) PROCEDURE WITH A 23MM SAPIEN 3 VALVE IN THE NATIVE AORTIC POSITION, ECHOCARDIOGRAPHY SHOWS ELEVATED GRADIENTS AND VELOCITIES, A DECREASED DIMENSIONLESS VALVE INDEX (DVI) AND LEAFLET CALCIFICATION. TOMOGRAPHY HAS BEEN PERFORMED TO FURTHER ASSESS THE VALVE AND THE TEAM WILL DECIDE ON A PLAN BASED ON THE SCAN. IT WAS NOTED THAT THE PATIENT'S POST TAVR COURSE WAS COMPLICATED IN YEAR 2020 BY COVID-19. THE PATIENT WAS ON LONG TERM VENTILATION THAT EVENTUALLY REQUIRED A TRACHEOSTOMY AND PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PLACEMENT, BOTH OF WHICH HAVE SINCE BEEN REMOVED). PER REPORT, THE PATIENT WAS ALSO ON CONTINUOUS VENO-VENOUS HEMOFILTRATION (CVVH) AND HAD A GASTROINTESTINAL BLEED (GIB) THAT REQUIRED A MASSIVE TRANSFUSION, ALONG WITH A PACEMAKER PLACEMENT ONE YEAR AFTER TAVR FOR SICK SINUS SYNDROME (SSS). ADDITIONAL INFORMATION PROVIDED PER VALVE CLINICAL COORDINATOR INDICATING THE PATIENT IS DYSPNEIC WITH DECREASED ET (END-TIDAL CARBON DIOXIDE), MOST LIKELY MULTIFACTORIAL CARDIAC/PULMONARY. THOUGHTS FOR THE PATIENT ARE SURGICAL EVALUATION/CONSULTATI

  Patient problems: Dyspnea

  MAUDE report 25236488 ↗
• InjuryMay 15, 2026Degraded

  AS REPORTED BY A FIELD CLINICAL SPECIALIST, APPROXIMATELY 6 YEARS AND 7 MONTHS POST TAVR WITH A 23MM SAPIEN 3 VALVE, THE VALVE WAS FAILING. PER ADDITIONAL INFORMATION PROVIDED THE PATIENT RECEIVED A 23MM SAPIEN 3 ULTRA RESILIA VALVE IN A VALVE IN VALVE PROCEDURE.

  Patient problems: Dyspnea

  MAUDE report 25194501 ↗
• InjuryMay 15, 2026Calcified

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), APPROXIMATELY 5 YEARS AND 4 MONTHS POST TRANSFEMORAL TAVR (TRANSCATHETER AORTIC VALVE REPLACEMENT) PROCEDURE WITH A 23 MM SAPIEN 3 VALVE IN THE NATIVE AORTIC POSITION, THE VALVE FAILED DUE TO STENOSIS AND CALCIFICATION. THE PATIENT UNDERWENT A SUCCESSFUL VALVE-IN-VALVE PROCEDURE WITH A SURGICAL VALVE. THE PATIENT'S FINAL OUTCOME WAS REPORTED AS BEING IN STABLE CONDITION.

  Patient problems: Insufficient Information

  MAUDE report 25187335 ↗
• InjuryMay 15, 2026Degraded

  AS REPORTED BY A FIELD CLINICAL SPECIALIST, APPROXIMATELY 7 YEARS AND 2 MONTHS POST TAVR WITH A 23MM SAPIEN 3 VALVE THE VALVE FAILED DUE TO STENOSIS AND CENTRAL REGURGITATION. AS A RESULT A 23MM SAPIEN 3 ULTRA VALVE WAS IMPLANTED IN A VALVE IN VALVE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25187194 ↗
• InjuryMay 15, 2026Degraded

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), APPROXIMATELY 8 YEARS AND 2 MONTHS POST TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) WITH A 23MM SAPIEN 3 VALVE, THE PATIENT PRESENTS WITH HALT, LEAFLET MOBILITY AND THICKENING. THE FCS ADVISED THAT THEY OBTAINED PROCTOR FEEDBACK AND INTERVENTION IS NOT YET SCHEDULED. PENDING RESPONSE FROM FCS ON INTERVENTION REQUIREMENT. UPON FOLLOW UP, THE FCS ADVISED THE PATIENT UNDERWENT A VIV. THE PATIENT IS STABLE.

  Patient problems: Insufficient Information

  MAUDE report 25186784 ↗
• InjuryMay 12, 2026Calcified

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST, APPROXIMATELY 6 YEARS AND 9 MONTHS FOLLOWING A TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE IMPLANTING A 23 MM SAPIEN 3 VALVE, A POTENTIAL VALVE IN VALVE PROCEDURE IS BEING PLANNED. PER MEDICAL RECORDS RECEIVED FOR THE PATIENT, THE PATIENT WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) AND EMPHYSEMA PRESENTED WITH WORSENING EXERTIONAL DYSPNEA. THE DEGENERATED BIOPROSTHETIC AORTIC VALVE EXHIBITED SEVERE STENOSIS AND REGURGITATION. A TRANSTHORACIC ECHOCARDIOGRAM NOTED THE AORTIC VALVE HAD THICKENED LEAFLETS WITH RESTRICTED MOTION, MODERATE AORTIC REGURGITATION AND SEVERE AORTIC STENOSIS WITH A MEAN GRADIENT OF 41.4 MMHG. A COMPUTERIZED TOMOGRAPHY SCAN NOTED CIRCUMFERENTIAL PANNUS ALONG THE INTERNAL ASPECT OF THE VALVE WITH POSTERIOR THICKENED LEAFLET, MODERATE CALCIFICATION, SEVERELY RESTRICTED LEAFLET MOTION, AND HALT INVOLVING THE COMMISSURES. IT IS BEING DISCUSSED WHETHER TO ADDRESS THE DEGENERATED VALVE WITH A VALVE IN VALVE OR A SURGICAL VALVE REPLACEMENT.

  Patient problems: Dyspnea

  MAUDE report 25149986 ↗
• InjuryMay 7, 2026Device Stenosis

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), APPROXIMATELY 6 YEARS POST TRANSFEMORAL TAVR PROCEDURE WITH A 23 MM SAPIEN 3 VALVE, THE VALVE IS FAILING. PER FEEDBACK FROM THE FCS, THE PATIENT HAS CONGESTIVE HEART FAILURE AND MODERATE TO SEVERE MITRAL REGURGITATION. INTERVENTION IS REQUIRED DUE TO SEVERE AORTIC STENOSIS, AND A VALVE-IN-VALVE PROCEDURE IS RECOMMENDED. A RECENT TRANSTHORACIC ECHOCARDIOGRAM DEMONSTRATED ELEVATED TRANSVALVULAR GRADIENTS, WITH A PEAK GRADIENT OF 100 MMHG, A MEAN GRADIENT OF 59 MMHG, AND AN AORTIC VALVE AREA OF 0.8 CM2.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 25119185 ↗
• InjuryMay 5, 2026Adverse Event Without Identified Device or Use Problem

  AS REPORTED FROM THE MEDICAL RECORDS RECEIVED, AFTER THE INITIAL OFF-LABEL TRANSCATHETER MITRAL VALVE REPLACEMENT (TMVR) PROCEDURE WITH A 23 MM SAPIEN 3 (S3) VALVE, THE PATIENT EXPERIENCED AN EMBOLIC CEREBROVASCULAR ACCIDENT (CVA). THE EXACT DATE OF THE EMBOLIC CVA WAS NOT PROVIDED. THE PATIENT WAS NOTED TO BE ON WARFARIN (2.5 MG, FIVE TIMES WEEKLY). NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Stroke/CVA

  MAUDE report 25083512 ↗
• InjuryMay 4, 2026Insufficient Device Problem Information

  IT WAS REPORTED VIA THE EDWARDS LIFESCIENCES IMPLANT PATIENT REGISTRY, APPROXIMATELY 6 YEARS AND 1 MONTHS POST IMPLANTATION OF A 23MM SAPIEN 3 VALVE IN THE AORTIC POSITION, THE VALVE WAS EXPLANTED. THE CAUSE OF THE EXPLANT AND PATIENT SYMPTOMS BEFORE THE EXPLANT WERE NOT PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 25072529 ↗
• DeathMay 4, 2026Degraded

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST, APPROXIMATELY 7 YEARS AND 8 MONTHS AFTER A TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE TO IMPLANT A 23 MM SAPIEN 3 VALVE, THE VALVE EXHIBITED STENOSIS. A VALVE IN VALVE PROCEDURE WAS BEING PLANNED. PER ADDITIONAL INFORMATION RECEIVED FROM THE VALVE CLINICAL COORDINATOR, THE PATIENT INITIALLY PRESENTED WITH POSSIBLE CONGESTIVE HEART FAILURE OR PNEUMONIA WITH HEART PALPITATIONS. AN ECHO REVEALED A VALVE AREA OF 0.6CM2, MODERATE AORTIC INSUFFICIENCY, MILD MITRAL REGURGITATION, MILD MITRAL STENOSIS, MILD TRICUSPID REGURGITATION. THE PATIENT PASSED AWAY PRIOR TO INTERVENTION BEING ABLE TO BE PERFORMED. THE PATIENT HAD A CODE BLUE EVENT BUT WAS ABLE TO BE RESUSCITATED. THE FAMILY MADE THE DECISION TO MOVE THE PATIENT TO HOSPICE, WHERE SHE PASSED AWAY. THE PERCEIVED CAUSE OF THE STENOSIS WAS ATTRIBUTED TO PATIENT RISK FACTORS SUCH AS CURRENT DAILY SMOKING, POOR DIET, NO OUTPATIENT FOLLOW UP SINCE THE LAST IMPLANT.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 25072410 ↗