EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE (THV) 9600TFX (REF 9600TFX29A)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,124 adverse event reports that list this exact device (DI 00690103194364), received between Mar 26, 2019 and Jun 22, 2026 — classified as 59 deaths, 1,038 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (240 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 1,124 reports, in the reporter's own words as published by the FDA.

• InjuryJun 22, 2026Device Stenosis

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), APPROXIMATELY 5 YEARS AND 9 MONTHS POST TRANSFEMORAL TAVR PROCEDURE WITH A 29MM SAPIEN 3 VALVE IN THE AORTIC POSITION, THE PATIENT UNDERWENT A VIV DUE TO STENOSIS. THE PROCEDURE WAS A SUCCESSFUL VIV WITH A 23MM SAPIEN 3 ULTRA RESILIA VALVE. THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE AND WAS TAKEN TO RECOVERY POST PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 25578911 ↗
• InjuryJun 11, 2026Calcified

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST, APPROXIMATELY 5 YEARS AND 4 MONTHS FOLLOWING INITIAL IMPLANT OF A 29 MM SAPIEN 3 VALVE VIA TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR), THE PATIENT PRESENTED WITH DYSPNEA, FATIGUE, AND HEART FAILURE. AN ECHOCARDIOGRAM NOTED MODERATE TO SEVERE AORTIC VALVE STENOSIS, PEAK VELOCITY 4.2 M/S, A MEAN GRADIENT OF 39 MMHG, AND A VALVE AREA OF 0.8 CM2. A VALVE IN VALVE PROCEDURE WAS PERFORMED DUE TO STENOSIS AND CALCIFICATION OF THE VALVE AND A 26 MM SAPIEN 3 ULTRA VALVE WAS SUCCESSFULLY IMPLANTED.

  Patient problems: Dyspnea; Fatigue; Heart Failure/Congestive Heart Failure

  MAUDE report 25473908 ↗
• InjuryJun 10, 2026Calcified; Perivalvular Leak

  AS REPORTED BY AN EDWARDS LIFESCIENCES FIELD CLINICAL SPECIALIST, A 29MM SAPIEN 3 VALVE, IMPLANTED IN THE AORTIC POSITION, FAILED DUE TO SIGNIFICANT PARAVALVULAR LEAK (PVL) APPROXIMATELY 5 YEARS AND 11 MONTHS POST IMPLANT. THE GRADIENT WAS REPORTED AS 35MMHG, BUT IT IS UNKNOWN IF IT WAS A PEAK OR MEAN VALVE GRADIENT. THE PERCEIVED ROOT CAUSE OF THE PVL WAS THOUGHT TO BE BULKY CALCIUM AT THE ANNULUS. THE PATIENT PRESENTED WITH FATIGUE AND SHORTNESS OF BREATH. A VALVE-IN-VALVE PROCEDURE WAS PERFORMED, AND A 26MM SAPIEN 3 ULTRA RESILIA VALVE WAS SUCCESSFULLY IMPLANTED WITHIN THE SAPIEN 3 VALVE. THE PATIENT IS STABLE AND IN RECOVERY.

  Patient problems: Dyspnea; Fatigue

  MAUDE report 25460581 ↗
• InjuryJun 4, 2026Calcified

  AS REPORTED BY AN EDWARDS LIFESCIENCES FIELD CLINICAL SPECIALIST, A 29MM SAPIEN 3 VALVE, IMPLANTED IN THE AORTIC POSITION, FAILED DUE TO STENOSIS AFTER AN IMPLANT DURATION OF 9 YEARS AND 1 MONTH. CT IMAGES WERE REVIEWED BY AN EDWARDS LIFESCIENCES CLINICAL IMAGER, AND IT WAS NOTED THAT ALL THREE SAPIEN 3 VALVE LEAFLETS WERE HEAVILY THICKENED AND CALCIFIED. VALVE EXPANSION AT THE WAIST MEASURED 546 MM, WHICH IS 85% OF NOMINAL. VALVE POSITION WAS GOOD. A VALVE-IN-VALVE PROCEDURE WAS NEEDED TO TREAT THE SAPIEN 3 VALVE. A UNICORN PROCEDURE WAS BEING PERFORMED FOR THE VALVE-IN-VALVE PROCEDURE. THE RIGHT CORONARY CUSP (RCC) LEAFLET WAS MODIFIED WITH SERIAL BALLOON DILATION. HOWEVER, THE NEW 26MM SAPIEN 3 ULTRA VALVE AND COMMANDER DELIVERY SYSTEM WOULD NOT CROSS THE RCC LEAFLET. AFTER MULTIPLE TECHNIQUE ATTEMPTS, THE SYSTEM BECAME LODGED IN THE PREEXISTING VALVE/AORTIC COMPLEX. THE SYSTEM WAS UNABLE TO BE PULLED BACK WITHOUT RISK OF EMBOLIZING THE VALVE AND/OR HARMING THE ANATOMY. IT WAS DECIDED TO CONVERT TO OPEN HEART SURGERY AND REMOVE THE SYSTEM AND UNDEPLOYED VALVE FROM THE AORTA. THE 29MM SAPIEN 3 VALVE WAS EXPLANTED.

  Patient problems: Insufficient Information

  MAUDE report 25402676 ↗
• InjuryJun 1, 2026Device Stenosis

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST, APPROXIMATELY 6 YEARS AND 2 MONTHS POST TAVR WITH A 29 MM SAPIEN 3 TRANSCATHETER HEART VALVE IN THE AORTIC POSITION, THE PATIENT UNDERWENT A VALVE-IN-VALVE DUE TO STENOSIS AND INCREASED GRADIENTS. THE PATIENT WAS SYMPTOMATIC PRIOR TO THE INTERVENTION, REPORTING DYSPNEA. THE VALVE'IN'VALVE PROCEDURE WAS INDICATED DUE TO BIOPROSTHETIC VALVE STENOSIS, WITH REPORTED PRE'INTERVENTION MEAN/PEAK GRADIENTS OF 35'50 MMHG AND A VALVE AREA OF 0.5'1.0 CM'. RELEVANT COMORBIDITIES INCLUDED DIABETES, PRIOR RADIATION THERAPY, LIVER TRANSPLANT, IMMUNE DEFICIENCY DISORDER, AND NONALCOHOLIC STEATOHEPATITIS (NASH). A 29 MM SAPIEN 3 TRANSCATHETER HEART VALVE WAS IMPLANTED SUCCESSFULLY IN THE AORTIC POSITION VIA TRANSFEMORAL ACCESS USING THE RIGHT FEMORAL ARTERY, AS A VALVE'IN'VALVE WITHIN THE FAILED PRIOR TRANSCATHETER VALVE. THE IMPLANT CHARACTERISTICS WERE CONSISTENT WITH A TRANSCATHETER HEART VALVE SYSTEM. THE VALVE WAS REPORTED TO BE IMPLANTED WITH PRECISE ALIGNMENT WITHIN THE PRIOR VALVE. NO DIFFICULTY USING THE DEVICE WAS REPORTED DURING THE CASE, AND NO CENTRAL LEAK WAS NOTED. POST'PROCEDURE TRANSTHORACIC ECHOCARDIOGRAPHY REPORTEDLY DEMONSTRATED A ME

  Patient problems: Dyspnea

  MAUDE report 25355027 ↗
• InjuryJun 1, 2026Degraded

  AS REPORTED BY A FIELD CLINICAL SPECIALIST, APPROXIMATELY 7 YEARS AND 7 MONTHS POST TAVR WITH A 29MM SAPIEN 3 VALVE, THE VALVE FAILED DUE TO STENOSIS AND MEAN GRADIENT OF 70MMHG. AS A RESULT, A 26 SAPIEN 3 ULTRA VALVE WAS IMPLANTED IN A VALVE IN VALVE PROCEDURE AT +1CC VOLUME, THEN POST DILATED WITH A 26MM TRU BALLOON. THERE WAS NO PVL AT THE END OF THE PROCEDURE AND A MEAN GRADIENT OF 10MMHG.

  Patient problems: Insufficient Information

  MAUDE report 25350090 ↗
• InjuryJun 1, 2026Calcified

  AS REPORTED BY ARTICLE "A BREAKTHROUGH HEART PROCEDURE COMES WITH RISKY TRADEOFFS" APPROXIMATELY 7 YEARS POST TAVR WITH A 29MM SAPIEN 3 VALVE, THE VALVE HAD BECOME CALCIFIED AND WAS LEAKING LEADING TO HEART FAILURE. THE PATIENT WAS SYMPTOMATIC WITH SHORTNESS OF BREATH AND CHEST TIGHTNESS. AS A RESULTS THE CARDIAC SURGEON WHO OPERATED AND REPLACED THE VALVE AND FIXED THREE BLOCKED ARTERIES.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 25349855 ↗
• InjuryMay 29, 2026Perivalvular Leak

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), APPROXIMATELY 5 YEARS, 6 MONTHS, 17 DAYS POST TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE WITH A 29 MM SAPIEN 3 VALVE, THE PATIENT PRESENTED HEART FAILURE DUE TO SEVERE PARAVALVULAR LEAK. THE PATIENT UNDERWENT A VALVE IN VALVE PROCEDURE WITH A 29 MM SAPIEN 3 ULTRA RESILIA VALVE WITH +3-5ML. THE FINAL RESULTS REDUCED TO MILD-MODERATE PARAVALVULAR LEAK. THE PROCEDURE WAS UNEVENTFUL, AND THE PATIENT REMAINED STABLE THROUGHOUT. THERE WAS ON ALLEGATION OF AN EDWARDS DEVICE DEFICIENCY.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 25336943 ↗
• InjuryMay 27, 2026Fracture; Device Stenosis

  AS REPORTED BY A FIELD CLINICAL SPECIALIST, APPROXIMATELY 7 YEARS POST TMVR WITH A 29MM SAPIEN 3 (S3) VALVE THIS VALVE FAILED DUE TO STENOSIS. ONCE THE CASE WAS STARTED THE TEAM FOUND THAT THE 29MM S3 IN THE MITRAL POSITION HAD A FRACTURE OF THE STENT FRAME. THE FRACTURE APPEARS TO HAPPEN IN THE OPEN CELL PART OF THE VALVE THAT WAS IN THE LEFT VENTRICLE. THERE DID NOT APPEAR TO BE ANY MISSING SECTIONS OF THE VALVE. THE TEAM WAS NOT AWARE THAT THE 29MM S3 WAS FRACTURED. THE TEAM PERFORMED A BATMAN PROCEDURE. A NEW 29MM SAPIEN 3 ULTRA RESILIA WAS PLACED INSIDE OF THE FRACTURE 29MM S3 IN THE MITRAL POSITION. THE PATIENT WAS STABLE THE WHOLE TIME. THE PATIENT HAD A HISTORY OF HEART FAILURE.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 25301295 ↗
• InjuryMay 26, 2026Insufficient Device Problem Information

  IT WAS REPORTED VIA THE EDWARDS LIFESCIENCES IMPLANT PATIENT REGISTRY, APPROXIMATELY 5 YEARS AND 4 MONTHS POST IMPLANTATION OF A 29 MM SAPIEN 3 VALVE IN THE AORTIC POSITION, THE VALVE WAS EXPLANTED. THE CAUSE OF THE EXPLANT AND PATIENT SYMPTOMS BEFORE THE IMPLANT WERE NOT PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 25280735 ↗
• InjuryMay 22, 2026Perivalvular Leak

  AS REPORTED BY A FIELD CLINICAL SPECIALIST (FCS), A PATIENT UNDERWENT A TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE WITH A 29 MM SAPIEN 3 VALVE IN AORTIC POSITION. APPROXIMATELY 3 YEARS AND 1 MONTH LATER, THE PATIENT PRESENTED WITH MODERATE-SEVERE PARAVALVULAR LEAK (PVL). THE PATIENT WAS BROUGHT IN TO THE HYBRID ROOM FOR A POST DILATION, PVL ASSESSMENT, AND REPEAT TAVR IF NECESSARY. THE POST-BAV WITH 4CC OF EXTRA VOLUME DID NOT RESOLVE THE PVL AND THE DECISION WAS MADE TO IMPLANT A 29MM SAPIEN 3 ULTRA RESILIA JUST VENTRICULAR TO THE INDEX VALVE. THIS WAS SUCCESSFUL, RESOLVING THE PVL. PATIENT REMAINED STABLE AND WENT TO RECOVERY.

  Patient problems: Insufficient Information

  MAUDE report 25251423 ↗
• InjuryMay 20, 2026Insufficient Device Problem Information

  AS REPORTED BY THE IMPLANT PATIENT REGISTRY TEAM, APPROXIMATELY 4 YEARS AND 8 MONTHS POST SUCCESSFUL TRANSFEMORAL AORTIC VALVE REPLACEMENT WITH A 29MM SAPIEN 3 TRANSCATHETER VALVE, THE VALVE WAS EXPLANTED AND REPLACED WITH A 27MM SURGICAL HEART VALVE. THE REASON FOR EXPLANT IS UNKNOWN AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 25234319 ↗
• InjuryMay 20, 2026Insufficient Device Problem Information

  AS REPORTED BY IMPLANT PATIENT REGISTRY, APPROXIMATELY 6 YEARS POST TAVR WITH A 29MM SAPIEN 3 VALVE, THE VALVE WAS EXPLANTED DUE TO UNKNOWN REASONS.

  Patient problems: Insufficient Information

  MAUDE report 25232808 ↗
• InjuryMay 20, 2026Gradient Increase; Perivalvular Leak

  IT WAS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), THAT APPROXIMATELY 6 YEARS, 4 MONTHS, 25 DAYS POST TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE WITH A 29MM SAPIEN 3 VALVE, THE PATIENT'S ECHO REVEALED MODERATE-SEVERE PARAVALVULAR REGURGITATION; WITH SEVERE REGURGITATION SUGGESTED BY HOLODIASTOLIC FLOW REVERSAL IN THE DESCENDING AORTA. THE PEAK SYSTOLIC VELOCITY IS 3.4 M/SEC AND THE MEAN SYSTOLIC GRADIENT IS 28.0 MM HG. THE VALVE AREA BY THE VELOCITY-TIME INTEGRAL METHOD IS 1.59 CM2 AND THE REGURGITATION PRESSURE HALF-TIME IS 555 MS. THE PATIENT UNDERWENT A SUCCESSFUL VALVE-IN-VALVE (VIV) PROCEDURE WITH A 29MM SAPIEN 3 ULTRA RESILIA VALVE.

  Patient problems: Insufficient Information

  MAUDE report 25229977 ↗
• InjuryMay 19, 2026Calcified

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), APPROXIMATELY 6 YEARS, 3 MONTHS, 1 DAY POST TRANSFEMORAL TAVR PROCEDURE WITH A 29MM SAPIEN 3 VALVE, THE VALVE PRESENTED STENOSIS. THE PATIENT UNDERWENT A SUCCESSFUL VALVE IN VALVE PROCEDURE WITH A 26MM SAPIEN 3 ULTRA RESILIA VALVE. PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT PRESENTED SHORTNESS OF BREATH WITH A MEAN GRADIENT OF 56.5MMHG AND A PEAK GRADIENT OF 97.9MMHG. THE VALVE AREA/INDEX OF THE FAILED VALVE WAS 0.54 CM2. THE LEAFLETS WERE CALCIFIED WITH LIMITED MOBILITY. THE PATIENT WAS DISCHARGED HOME. DURING THE VALVE IN VALVE PROCEDURE, THE BALLOON ON THE 26MM COMMANDER DELIVERY SYSTEM BURST CIRCUMFERENTIALLY DURING VALVE DEPLOYMENT AT FULL INFLATION WITH +1CC. DURING WITHDRAWAL, THERE WERE DIFFICULTIES. HOWEVER, THE BALLOON WAS ABLE TO BE PULLED BACK INTO THE 14FR ESHEATH+ AND REMOVED. A NEW 14FR ESHEATH+ WAS INSERTED. THE PATIENT WAS STABLE AND THE ESHEATH+ WAS REMOVED WITH SUCCESSFUL GROIN CLOSURE. THE PATIENT WAS SENT TO RECOVERY. THERE WAS NO INJURY TO THE PATIENT. PER REPORT, BAV WAS PERFORMED PRE-IMPLANT. VALVE ALIGNMENT WAS PERFORMED IN A STRAIGHT SECTION.

  Patient problems: Insufficient Information

  MAUDE report 25216844 ↗
• InjuryMay 18, 2026Calcified

  AS REPORTED BY AN EDWARDS LIFESCIENCES FIELD CLINICAL SPECIALIST (FCS), APPROXIMATELY 5 YEARS AND 6 MONTHS POST IMPLANTATION OF A 29MM SAPIEN 3 VALVE IN THE AORTIC POSITION, A VALVE IN VALVE WITH A 26MM SAPIEN 3 ULTRA VALVE DUE TO SEVERE CALCIFICATION OF THE PROSTHETIC LEAFLETS. PATIENT SYMPTOMS BEFORE VALVE IN VALVE WAS FATIGUE AND HEART FAILURE. PER FCS, SUBOPTIMAL COMMISSURAL ALIGNMENT, NATIVE ANATOMY APPEARS CONSISTENT WITH BICUSPID VALVE (SIEVERS 0), UNDEREXPANSION OF THE THV AT THE MID PORTION AND SIGNIFICANT CALCIFICATION OF THE NATIVE ANATOMY.

  Patient problems: Dyspnea; Heart Failure/Congestive Heart Failure

  MAUDE report 25209344 ↗
• InjuryMay 18, 2026Insufficient Device Problem Information

  IT WAS REPORTED VIA THE EDWARDS LIFESCIENCES IMPLANT PATIENT REGISTRY, APPROXIMATELY 6 YEARS AND 1 MONTH POST IMPLANTATION 29 MM SAPIEN 3 VALVE IN THE AORTIC POSITION, THE VALVE WAS EXPLANTED. THE CAUSE OF THE EXPLANT AND PATIENT SYMPTOMS BEFORE THE EXPLANT ARE UNKNOWN AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 25209248 ↗
• InjuryMay 15, 2026Device Stenosis

  AS REPORTED BY A FIELD CLINICAL SPECIALIST (FCS), APPROXIMATELY 7 YEARS AND 9 MONTHS POST-IMPLANT OF A 29 MM SAPIEN 3 VALVE IN THE AORTIC POSITION VIA TRANSFEMORAL APPROACH, THE VALVE FAILED DUE TO AORTIC STENOSIS DUE TO DISEASE PROGRESSION PER MEDICAL DOCTOR. A VALVE IN VALVE WAS SUCCESSFULLY PERFORMED WITH 26 MM SAPIEN 3 ULTRA RESILIA. THE PATIENT IS DOING WELL.

  Patient problems: Insufficient Information

  MAUDE report 25194134 ↗
• InjuryMay 15, 2026Perivalvular Leak; Device Stenosis

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), APPROXIMATELY 5 YEARS AND 9 MONTHS POST TRANSFEMORAL TAVR (TRANSCATHETER AORTIC VALVE REPLACEMENT) PROCEDURE WITH A 29MM SAPIEN 3 VALVE IN THE NATIVE AORTIC POSITION, THE VALVE FAILED DUE TO STENOSIS AND A PARAVALVULAR LEAK (PVL). THE PATIENT PRESENTED WITH DYSPNEA AND FATIGUE. THE PATIENT UNDERWENT A SUCCESSFUL VALVE-IN-VALVE PROCEDURE WITH A 29MM SAPIEN 3 ULTRA RESILIA VALVE. THE PATIENT'S FINAL OUTCOME WAS REPORTED AS BEING IN STABLE CONDITION.

  Patient problems: Dyspnea

  MAUDE report 25187248 ↗
• InjuryMay 15, 2026Calcified

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST, APPROXIMATELY 7 YEARS POST RIGHT TRANSFEMORAL TAVR PROCEDURE WITH A 29 MM SAPIEN 3 VALVE, THE PATIENT PRESENTED WITH CHEST PAIN AND HEART FAILURE. THE PATIENT UNDERWENT A VALVE-IN-VALVE PROCEDURE WITH A 26 MM SAPIEN 3 ULTRA RESILIA VALVE DUE TO STENOSIS, REGURGITATION AND CALCIFICATION. THE VALVE WAS PLACED SUCCESSFULLY AND THE PATIENT LEFT ROOM IN STABLE CONDITION. BASED ON THE MEDICAL RECORD REVIEW, THE PATIENT WAS INITIALLY ADMITTED FOR CHRONIC OBSTRUCTIVE PULMONARY DISEASE AND CONGESTIVE HEART FAILURE EXACERBATION AND WAS DISCHARGED. THE PATIENT RETURNED SHORTLY THEREAFTER WITH WORSENING DYSPNEA AND ALTERED MENTAL STATUS, REQUIRING INTENSIVE CARE UNIT ADMISSION FOR ACUTE-ON-CHRONIC HYPOXIC AND HYPERCAPNIC RESPIRATORY FAILURE. DURING THIS HOSPITALIZATION, THE PATIENT EXPERIENCED A NON-ST-ELEVATION MYOCARDIAL INFARCTION WITH WORSENING RENAL FUNCTION CONSISTENT WITH CARDIORENAL SYNDROME, AS WELL AS SEVERE AORTIC STENOSIS, AND WAS UNDER EVALUATION FOR A REPEAT TRANSCATHETER AORTIC VALVE REPLACEMENT. WHILE HOSPITALIZED, THE PATIENT EXPERIENCED A CARDIAC ARREST FOLLOWING RETURN FROM AN UNSPECIFIED COMPUTED TOMOGRAPHY SCAN, WHICH WAS DETER

  Patient problems: Chest Pain; Heart Failure/Congestive Heart Failure

  MAUDE report 25179944 ↗
• InjuryMay 14, 2026Insufficient Device Problem Information

  AS REPORTED BY IMPLANT PATIENT REGISTRY THROUGH RECEIPT OF AN IMPLANT DATA CARD, APPROXIMATELY 6 MONTHS POST TRANSFEMORAL TAVR PROCEDURE WITH A 29 MM SAPIEN 3 VALVE, THE PATIENT'S VALVE WAS EXPLANTED AND REPLACED WITH A SURGICAL VALVE. THE CAUSE OF THE EXPLANT IS UNKNOWN AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 25176160 ↗
• InjuryMay 13, 2026Calcified

  IT WAS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS) THAT APPROXIMATELY 5 YEARS, 5 MONTHS, AND 21 DAYS POST TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) WITH A 29 MM SAPIEN 3 VALVE THE VALVE FAILED DUE TO POSSIBLE THROMBUS/HALT. THE VALVE IS BEING CHECKED AND THERE IS NO FURTHER INFORMATION AT THIS TIME. IMAGERY REVIEW WAS PROVIDED AND FOUND THAT THIS PATIENT COMPUTED TOMOGRAPHY (CT) SHOWED, THE S3 VALVE HAS MILD TO MODERATE CALCIFICATIONS OF ALL 3 PROSTHETIC LEAFLETS. WHILE THERE IS THICKENING OF THE LEAFLETS PREDOMINANTLY AT THE R-LCC COMMISSURE WHICH COULD SUGGEST LEAFLET THROMBOSIS OR PANNUS, THIS IS NOT LIKELY AN ACUTE PROCESS. EVEN IF THERE WAS HALT, AT THIS POINT IT IS SEQUELAE RATHER THAN MODIFIABLE, AND THE CALCIFICATIONS SUGGESTS TYPICAL VALVE DEGENERATION AS THE CAUSE RATHER THAN HALT. IT IS UNLIKELY THAT A TRIAL OF ANTICOAGULATION WILL IMPROVE LEAFLET FUNCTION GIVEN THE CALCIFICATIONS. ADDITIONAL INFORMATION WAS RECEIVED; THE PATIENT HAD A VALVE IN VALVE WITH A 26 MM SAPIEN 3 ULTRA RESILIA VALVE. THE POST ECHO SHOWED A GRADIENT OF 8 AND THERE WAS NO LEAK. THE PATIENT TOLERATED THE PROCEDURE WELL.

  Patient problems: Insufficient Information

  MAUDE report 25160873 ↗
• InjuryMay 12, 2026Calcified

  AS REPORTED BY IMPLANT PATIENT REGISTRY, APPROXIMATELY FIVE YEARS AND TWENTY-ONE DAYS POST IMPLANTATION OF A 29 MM SAPIEN 3 VALVE IN THE AORTIC POSITION, THE DEVICE WAS EXPLANTED AND REPLACED WITH A SURGICAL VALVE DUE TO CALCIFICATION. PER MEDICAL RECORD REVIEW, THIS PATIENT UNDERWENT A CORONARY ARTERY BYPASS GRAFTING DUE TO MULTIPLE FAILED PERCUTANEOUS INTERVENTIONS AND AORTIC VALVE EXPLANT AND REPLACEMENT DUE TO AORTIC STENOSIS AND INSUFFICIENCY, APPROXIMATELY 5 YEARS AND 1 MONTH POST TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR). THE PATIENT WAS HAVING PROGRESSIVE ANGINA WITH EXERTION. THE VALVE WAS REPLACED WITH A 27 MM MAGNA VALVE. ACCORDING TO THE PATHOLOGY REPORT DIAGNOSIS- AORTIC VALVE, TRANSCATHETER REPLACEMENT- VALVE WITH FIBROCALCIFIC DEGENERATION.

  Patient problems: Chest Pain

  MAUDE report 25152423 ↗
• InjuryMay 11, 2026Insufficient Device Problem Information

  AS REPORTED BY OUR IMPLANT PATIENT REGISTRY APPROXIMATELY 3 YEARS, 8 MONTHS AND 12 DAYS POST-SUBCLAVIAN TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) WITH A 29MM SAPIEN 3 VALVE THE VALVE WAS EXPLANTED FOR UNKNOWN REASONS, AND A SURGICAL VALVE WAS IMPLANTED.

  Patient problems: Insufficient Information

  MAUDE report 25135202 ↗
• InjuryMay 8, 2026Perivalvular Leak

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), APPROXIMATELY 1 YEAR AND 8 MONTHS POST TRANSCATHETER VALVE REPLACEMENT PROCEDURE WITH A 29MM SAPIEN 3 VALVE, THE VALVE FAILED DUE TO MODERATE-TO-SEVERE PARAVALVULAR LEAK (PVL) AT THE LEFT CUSP, AS DETECTED BY TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). THE PHYSICIAN REQUESTED AN EDWARDS REPRESENTATIVE BE PRESENT FOR A RE-DILATION. THE FIRST DILATION WAS A NOMINALLY PREPPED 29MM COMMANDER DELIVERY SYSTEM, AND THE PVL IMPROVED TO MODERATE. AFTER DISCUSSING WITH THE OPERATING TEAM, THE DECISION WAS MADE TO ADD AN ADDITIONAL 1ML TO THE BALLOON AND POST DILATE AGAIN, BUT WITH CONCERN FOR ANNULAR RUPTURE. THE POST-DILATION WAS PERFORMED SUCCESSFULLY AND THE PVL HAD REDUCED TO MILD PER TEE. AT THIS POINT, THE TEAM DECIDED THAT THEY WOULD STOP RATHER THAN RISK A RUPTURE, CONSIDERING THE PATIENT'S AGE AND CALCIUM BURDEN. IT WAS NOTED THAT THE PATIENT HAD A KNOWN ENLARGED ROOT PREVIOUSLY AND CALCIUM AT THE LEFT CUSP, EXTENDING INTO THE LEFT VENTRICULAR OUTFLOW TRACT (LVOT). ALSO, THE PVL WAS PRESENT AT INITIAL IMPLANT AND WAS TRACE AT THAT TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25125607 ↗