EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE (THV) 9300TFX (REF 9300TFX26A)Recalls & reported problems

Summary

The FDA's MAUDE database contains 64 adverse event reports that list this exact device (DI 00690103192087), received between Mar 1, 2021 and Jun 22, 2026 — classified as 1 death, 63 injuries.

The most frequently reported specific device problem is “Degraded” (27 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 64 reports, in the reporter's own words as published by the FDA.

• InjuryJun 22, 2026Device Stenosis

  AS REPORTED BY AN EDWARDS LIFESCIENCES FIELD CLINICAL SPECIALIST, APPROXIMATELY 10 YEARS AND 6 MONTHS POST IMPLANTATION OF A 26MM SAPIEN XT VALVE IN A ON EDWARDS SURGICAL VALVE IN THE TRICUSPID POSITION, A VALVE IN VALVE WITH 23MM SAPIEN 3 ULTRA RESILIA VALVE WAS PERFORMED DUE TO STENOSIS. PATIENT SYMPTOMS NOT PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 25580972 ↗
• DeathApr 24, 2026Device Stenosis

  EDWARDS RECEIVED NOTIFICATION FROM A FIELD CLINICAL SPECIALIST THAT A 26MM SAPIEN XT VALVE, IMPLANTED IN THE AORTIC POSITION, IS FAILING AFTER AN IMPLANT DURATION OF 10 YEARS AND 11 MONTHS DUE TO STENOSIS. A VALVE IN VALVE PROCEDURE WAS SCHEDULED. THROUGH FOLLOW UP WITH THE VALVE CLINIC COORDINATOR, IT WAS REPORTED THAT THE PATIENT PASSED AWAY PRIOR TO THE VALVE IN VALVE PROCEDURE. THE PATIENT'S VALVE WAS STENOTIC AND THE PATIENT HAD SYMPTOMS OF FATIGUE AND EDEMA. THE PATIENTS CO-MORBIDITIES INCLUDED NONALCOHOLIC STEATOHEPATITIS (NASH), DIABETES MELLITUS (DM), ANEMIA AND CHRONIC RESPIRATORY FAILURE. THE PATIENT'S RECENT ECHO SHOWED A LEFT VENTRICULAR EJECTION FRACTION (LVEF) OF 65-70%, MODERATE AORTIC STENOSIS S/P TAVR, MODERATE TRICUSPID REGURGITATION, MILD-MODERATE MITRAL REGURGITATION, MODERATE-SEVERE MITRAL ANNULAR CALCIFICATION, AND NO MITRAL STENOSIS.

  Patient problems: Dyspnea; Fatigue

  MAUDE report 24988784 ↗
• InjuryApr 13, 2026Degraded

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST, APPROXIMATELY TEN YEARS AND NINE MONTHS FOLLOWING A TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE WITH A 26MM SAPIEN XT VALVE, THE PATIENT PRESENTED WITH DYSPNEA. ECHOCARDIOGRAPHY DEMONSTRATED MIXED AORTIC STENOSIS AND A MILD CENTRAL LEAK. THE PATIENT SUBSEQUENTLY UNDERWENT A SUCCESSFUL VALVE-IN-VALVE PROCEDURE USING A 20MM SAPIEN 3 ULTRA RESILIA VALVE. THE PATIENT WAS REPORTED TO BE STABLE FOLLOWING THE PROCEDURE.

  Patient problems: Dyspnea

  MAUDE report 24866957 ↗
• InjuryMar 13, 2026Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY IMPLANT PATIENT REGISTRY, THE PATIENT HAD A SUCCESSFUL TAVR PROCEDURE USING A 26MM SAPIEN XT VALVE IN THE AORTIC POSITION. DURING THE PROCEDURE THE PATIENT DEVELOPED A TRANSIENT AV BLOCK. WHILE THE HEART BLOCK RESOLVED WITH A RETURN OF NORMAL QRS DIMENSION, THE BLOCK NECESSITATED THE NEED FOR INSERTION OF A NEW TEMPORARY PACEMAKER. DUE TO CHALLENGES FACED DURING TEMPORARY PACEMAKER LEAD PLACEMENT, BOTH THE LEFT GROIN VEIN AND THE RIGHT AXILLARY SUBCLAVIAN VEIN ACCESSES WERE UTILIZED.

  Patient problems: Heart Block

  MAUDE report 24590419 ↗
• InjuryDec 22, 2025Device Stenosis; Device Stenosis

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), APPROXIMATELY (B)(6) POST TRANSFEMORAL TMVR (TRANSCATHETER MITRAL VALVE REPLACEMENT) PROCEDURE WITH A 26MM SAPIEN XT VALVE IN THE NATIVE MITRAL POSITION, THE VALVE FAILED DUE TO STENOSIS. PER REPORT, THE PATIENT PRESENTED WITH SHORTNESS OF BREATH. THE PATIENT UNDERWENT A SUCCESSFUL VALVE-IN-VALVE PROCEDURE WITH A 23MM SAPIEN 3 ULTRA RESILIA VALVE. THE PATIENT IS IN STABLE CONDITION.

  Patient problems: Dyspnea

  MAUDE report 23872718 ↗
• InjuryOct 17, 2025Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST, 10 YEARS AND 8.5 MONTHS FOLLOWING A TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE WITH A 26MM SAPIEN XT VALVE IMPLANTED WITHIN A THV IMPLANTED WITHIN A HOMOGRAFT, THE PATIENT WAS FOUND TO HAVE 3 TO 4+ CENTRAL AORTIC INSUFFICIENCY AND WILL MOST LIKELY BE TREATED WITH A SURGICAL EXPLANT. AFTER REVIEWING THE MEDICAL RECORDS PROVIDED, THE PATIENT IS A 63-YEAR-OLD MALE, WITH A HISTORY OF AORTIC ROOT HOMOGRAFT, HOMOGRAFT VALVE STENOSIS, HEART FAILURE WITH PRESERVED EJECTION FRACTION, NON-OBSTRUCTIVE CORONARY ARTERY DISEASE, NEW-ONSET ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE, STAGE IV CHRONIC KIDNEY DISEASE, MESENTERIC ADENOPATHY, CHRONIC LYMPHEDEMA, GASTROINTESTINAL BLEEDING, GASTRIC ULCER, THROMBOCYTOPENIA, AND ARTHRITIS, WHO UNDERWENT A IMPLANTATION OF A 26MM XT VALVE IN THE FAILED HOMOGRAFT ON (B)(6) 2015. THE INITIAL VALVE WAS DEPLOYED TOO VENTRICULAR WITHIN THE HOMOGRAFT, NECESSITATING DEPLOYMENT OF A SECOND 26MM XT VALVE. THIS EVENT WAS PREVIOUSLY DOCUMENTED UNDER COMPLAINT (B)(4) IN THE EDWARDS PILGRIM SYSTEM. APPROXIMATELY 10 YEARS AND 8 MONTHS POST-IMPLANTATION, THE PATIENT WAS HOSPITALIZED FOR GASTROINTEST

  Patient problems: Insufficient Information

  MAUDE report 23327611 ↗
• InjurySep 10, 2025Degraded; Degraded

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST, A PATIENT WITH A 26 MM SAPIEN XT AORTIC VALVE IMPLANTED FOR 9 YEARS AND 8 MONTHS UNDERWENT A VALVE-IN-VALVE PROCEDURE DUE TO STENOSIS AND CENTRAL LEAK WITH SHORT OF BREATH. THE PATIENT WAS TREATED WITH A 23MM SAPIEN 3 ULTRA RESILIA VALVE. THE PATIENT WAS STABLE AFTER THE PROCEDURE.

  Patient problems: Dyspnea

  MAUDE report 23022705 ↗
• InjurySep 9, 2025Intravalvular regurgitation; Unspecified Valve Regurgitation; Intravalvular regurgitation; Unspecified Valve Regurgitation

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST, APPROXIMATELY 10 YEARS POST TRANSFEMORAL TAVR PROCEDURE WITH A 26 MM SAPIEN XT VALVE, THE VALVE IS FAILING DUE TO REGURGITATION. THE PATIENT WAS TREATED WITH A 26 MM SAPIEN 3 ULTRA RESILIA VALVE IN A VALVE-IN-VALVE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Dyspnea; Insufficient Information

  MAUDE report 23000277 ↗
• InjuryAug 28, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  EDWARDS RECEIVED NOTIFICATION FROM THE IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 9300TFX 26MM SAPIEN XT VALVE, IMPLANTED IN THE AORTIC POSITION, UNDERWENT AN EXPLANT PROCEDURE AFTER AN IMPLANT DURATION OF 10 YEARS AND 6 MONTHS DUE TO UNKNOWN REASONS. A 23MM EDWARDS SURGICAL VALVE WAS IMPLANTED IN REPLACEMENT.

  Patient problems: Endocarditis; Insufficient Information

  MAUDE report 22918231 ↗
• InjuryJul 1, 2025Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY AN EDWARDS LIFESCIENCES FIELD CLINICAL SPECIALIST, APPROXIMATELY 8 YEARS AND 2 MONTHS POST IMPLANTATION OF A 26MM SAPIEN XT VALVE IN A PRE-EXISTING 25MM SURGICAL VALVE IN THE AORTIC POSITION, A VALVE IN VALVE WITH A 23MM SAPIEN 3 ULTRA RESILIA VALVE WAS PERFORMED DUE TO CENTRAL REGURGITATION. BEFORE THE VALVE IN VALVE HER PRESENTING COMPLAINT WAS HEART FAILURE. SHE WAS SENT TO RECOVERY POST PROCEDURE IN STABLE CONDITION AND WAS DISCHARGED.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 22374059 ↗
• InjuryMay 13, 2025Degraded; Degraded

  AS REPORTED BY A FIELD CLINICAL SPECIALIST (FCS), APPROXIMATELY 8 YEARS AND 7 MONTHS POST-IMPLANT OF A 26 MM SAPIEN XT VALVE IN THE PULMONIC POSITION VIA TRANSFEMORAL, THE VALVE FAILED DUE TO STENOSIS AND REGURGITATION. A VALVE IN VALVE WAS SUCCESSFULLY IMPLANTED WITH NO COMPLICATION.

  Patient problems: Insufficient Information

  MAUDE report 22011477 ↗
• InjuryApr 24, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT APPROXIMATELY 9 YEARS, 2 MONTHS, AND 15 DAYS POST TMVR WITH A 26MM EDWARDS SAPIEN XT VALVE, THE VALVE IS FAILING DUE TO STENOSIS. THE PATIENT IS BEING WORKED UP FOR A VALVE IN VALVE.

  Patient problems: Insufficient Information

  MAUDE report 21903549 ↗
• InjuryMar 27, 2025Intravalvular regurgitation; Intravalvular regurgitation

  AS REPORTED BY A FIELD CLINICAL SPECIALIST (FCS), THE PATIENT UNDERWENT A VIV APPROXIMATELY 10 YEARS, POST TRANSFEMORAL TAVR PROCEDURE WITH A 26MM SAPIEN XT VALVE IN THE AORTIC POSITION. THE PATIENT HAS AN LVAD IN PLACE. THE PATIENT PRESENTED WITH FATIGUE AND SHORTNESS OF BREATH. THE REPORTED FAILURE MODE OF THE VALVE IS AI/REGURGITATION/CENTRAL LEAK DUE TO LVAD. THE PATIENT WAS DISCHARGED.

  Patient problems: Dyspnea

  MAUDE report 21713726 ↗
• InjuryMar 27, 2025Intravalvular regurgitation; Unspecified Valve Regurgitation; Intravalvular regurgitation; Unspecified Valve Regurgitation

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST, APPROXIMATELY 10 YEARS POST TRANSFEMORAL TAVR PROCEDURE WITH A SAPIEN XT VALVE, THE PATIENT PRESENTED WITH SHORTNESS OF BREATH. THE VALVE WAS FAILING DUE TO CENTRAL REGURGITATION. A VALVE-IN-VALVE WAS PERFORMED WITH A 23 MM SAPIEN 3 ULTRA RESILIA VALVE. NO PATIENT COMPLICATIONS WERE REPORTED. PER MEDICAL RECORDS REVIEWED, A TRANSTHORACIC ECHOCARDIOGRAM PRIOR DEPLOYMENT OF THE SECOND VALVE REPORTED PRE-EXISTING BIOPROSTHETIC VALVE WITH SEVERE AORTIC INSUFFICIENCY AND PEAK VELOCITY 2.6 M/S. POST DEPLOYMENT OF THE 2ND VALVE, THE AORTIC MEAN GRADIENT WAS 10.8 MMHG. A TRANSTHORACIC ECHOCARDIOGRAM (TTE) PERFORMED LATER ON THE SAME DAY REPORTED THE 23MM SAPIEN 3 ULTRA RESILIA VALVE IN AORTIC POSITION WITH EVIDENCE OF NORMAL BIOPROSTHETIC VALVE FUNCTION.

  Patient problems: Dyspnea; Insufficient Information

  MAUDE report 21708496 ↗
• InjuryFeb 14, 2025Degraded; Degraded

  AS REPORTED BY A FIELD CLINICAL SPECIALIST, APPROXIMATELY 16 YEARS POST TAVR WITH A SAPIEN XT VALVE, THE VALVE FAILED DUE TO AORTIC STENOSIS AND REGURGITATION. AS A RESULT A VALVE IN VALVE PROCEDURE WAS COMPLETED WITH A 26MM SAPIEN 3 ULTRA VALVE.

  Patient problems: Insufficient Information

  MAUDE report 21385500 ↗
• InjuryJan 8, 2025Calcified; Degraded; Calcified; Degraded

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), 8 YEARS, 6 MONTHS, AND 27 DAYS POST-IMPLANT OF A 26 MM SAPIEN XT VALVE IN THE PULMONIC POSITION, THE 26 MM SAPIEN XT VALVE REQUIRED INTERVENTION DUE TO STENOSIS AND REGURGITATION. THERE WAS ALSO SOME LEAFLET THICKENING AND SOME 'CALCIFICATION' NOTED AT THE TIME OF THE VALVE IN VALVE IMPLANT, THOUGH NEITHER OF THESE WERE MENTIONED IN THE MEDICAL RECORDS THAT WERE RECEIVED. ON A ROUTINE FOLLOW UP IN (B)(6) 2024 THE ECHO SHOWED A 70MM GRADIENT AND PLANNING WAS STARTED FOR POSSIBLE RE-VALVING. WHILE IN THE CATH LAB FOR THIS PROCEDURE, A 46MM GRADIENT WAS NOTED AT THE START OF THE CASE. AFTER PRE-DILATION WITH A 26MM TRUE BALLOON, A VALVE IN VALVE WAS SUCCESSFULLY COMPLETED WITH A 26MM SAPIEN 3 ULTRA RESILIA. THE PATIENT WAS DISCHARGED HOME THE FOLLOWING DAY. THE PATIENT WAS EXPERIENCING SHORTNESS OF BREATH AND EXERCISE INTOLERANCE.

  Patient problems: Dyspnea

  MAUDE report 21104421 ↗
• InjuryNov 27, 2024Calcified; Calcified

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), APPROXIMATELY 7 YEARS AND 11 MONTHS POST TRANSAPICAL TMVR (TRANSCATHETER MITRAL VALVE REPLACEMENT) PROCEDURE WITH A 26MM SAPIEN XT VALVE IN A PRE-EXISTING 27MM NON-EDWARDS PROSTHETIC VALVE, THE PATIENT WAS READMITTED DUE TO HEART FAILURE. IT WAS DISCOVERED THAT THE SAPIEN XT VALVE FAILED DUE TO STENOSIS CAUSED BY CALCIFICATION, WITH THE MEAN GRADIENT MEASURING 17MMHG. THE PATIENT UNDERWENT A SUCCESSFUL VALVE IN VALVE PROCEDURE WITH A 23MM SAPIEN 3 ULTRA RESILIA WITH +2CC NOMINAL VOLUME AND NO COMPLICATIONS. PER REPORT, THE MEAN GRADIENT WAS 5MMHG AT THE CONCLUSION OF THE PROCEDURE.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 20797339 ↗
• InjuryNov 26, 2024Perivalvular Leak; Perivalvular Leak

  EDWARDS RECEIVED NOTIFICATION FROM THE IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 9300TFX 26MM SAPIEN 3 XT VALVE, IMPLANTED IN THE AORTIC POSITION, UNDERWENT AN EXPLANT PROCEDURE AFTER AN IMPLANT DURATION OF 9 YEARS AND 3 MONTHS DUE TO UNKNOWN REASONS. PER MEDICAL RECORD, THE VALVE WAS EXPLANTED DUE SEVERE PERIVALVULAR REGURGITATION AND CHF, ASCENDING AORTIC ANEURYSM. THE PATIENT WAS SYMPTOMATIC WITH HEMOLYTIC ANEMIA SECONDARY TO AORTIC VALVE ERYTHROCYTE SHEAR. A 25MM EDWARDS SURGICAL VALVE WAS IMPLANTED.

  Patient problems: Hemolytic Anemia

  MAUDE report 20781129 ↗
• InjuryOct 17, 2024Degraded; Degraded

  AS REPORTED BY THE EDWARDS CLINICAL SPECIALIST, A PATIENT WITH A 26MM SAPIEN XT MITRAL VALVE IMPLANTED FOR 9 YEARS AND 10 MONTHS UNDERWENT A VALVE-IN-VALVE PROCEDURE DUE TO SEVERE BIOPROSTHETIC PROSTHETIC MITRAL STENOSIS, MITRAL VALVE MEAN GRADIENT 12 MMHG, SEVERELY RESTRICTED MITRAL VALVE LEAFLETS MOTION, AND MILD CENTRAL AND PARAVALVULAR MITRAL VALVE REGURGITATION. A 23MM SAPIEN 3 ULTRA RESILIA VALVE WAS SUCCESSFULLY IMPLANTED. PATIENT WAS DOING GREAT.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 20468190 ↗
• InjuryAug 22, 2024Degraded; Degraded

  EDWARDS RECEIVED NOTIFICATION FROM A FIELD CLINICAL SPECIALIST THAT A PATIENT WITH A 26MM SAPIEN XT VALVE, IMPLANTED IN THE AORTIC POSITION, UNDERWENT A VIV PROCEDURE AFTER AN IMPLANT DURATION OF 7 YEARS AND 11 MONTHS DUE TO STENOSIS AND REGURGITATION. A 23MM SAPIEN 3 ULTRA VALVE WAS DEPLOYED SUCCESSFULLY. NO ADDITIONAL DETAILS WERE PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 20034570 ↗
• InjuryJul 1, 2024Intravalvular regurgitation; Intravalvular regurgitation

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), APPROXIMATELY 9 YEARS AND 2 MONTHS POST TRANSFEMORAL TAVR PROCEDURE WITH A 26MM SAPIEN XT VALVE IN A HOMOGRAFT VALVE, THE PATIENT PRESENTED WITH DYSPNEA AND "ABDOMINAL PRESSURE". THERE IS SEVERE AORTIC VALVE REGURGITATION PER TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) WITH A CENTRALLY DIRECTED REGURGITANT JET ORIGINATING BETWEEN THE RIGHT AND NON-CORONARY CUSPS, AND SIGNIFICANT FLOW REVERSAL IN THE DISTAL ASCENDING AORTA. THERE IS A MASS THAT LIKELY REPRESENTS A FLAIL LEAFLET VERSUS VEGETATION ARISING AT 2:00 O'CLOCK (LOCATION OF THE NATIVE LEFT CORONARY LEAFLET), LEADING TO THE SEVERE REGURGITATION; THIS IS LESS LIKELY THROMBUS. FURTHER EVALUATION IS LIMITED DUE TO ACOUSTIC SHADOWING. ADDITIONAL INTERVENTION IS BEING PLANNED.

  Patient problems: Dyspnea

  MAUDE report 19652239 ↗
• InjuryJun 24, 2024Device Stenosis; Device Stenosis

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST, APPROXIMATELY 7 YEARS POST TRANSAPICAL TMVR PROCEDURE WITH A 26 MM SAPIEN XT VALVE IN FAILED MITRAL MAGNA VALVE, THE PATIENT PRESENTED WITH A SHORTNESS OF BREATH, DIZZINESS, AND FATIGUE. THE XT VALVE IS FAILING DUE TO STENOSIS. THE PHYSICIAN STATED THE FAILURE MODE IS DUE TO THE DISEASE PROGRESSION. A VALVE-IN-VALVE-IN-VALVE WAS PERFORMED WITH A 23 MM SAPIEN 3 ULTRA RESILIA WITH NO ISSUES. THE PERCEIVED ROOT CAUSE OF THE STENOSIS WAS NOT IDENTIFIED. THE PATIENT WAS DISCHARGED HOME.

  Patient problems: Dyspnea

  MAUDE report 19599784 ↗
• InjuryJun 14, 2024Insufficient Device Problem Information; Device Stenosis; Insufficient Device Problem Information; Device Stenosis

  AS REPORTED THROUGH EDWARDS LIFESCIENCES IMPLANT PATIENT REGISTRY (IPR), APPROXIMATELY 7 YEARS POST TRANSVENOUS TRANSCATHETER PULMONARY VALVE REPLACEMENT PROCEDURE (TPVR) WITH A 26MM SAPIEN XT VALVE IN PULMONIC POSITION, A VALVE IN VALVE PROCEDURE WAS PERFORMED DUE TO UNKNOWN REASONS. PER MEDICAL RECORDS RECEIVED, THE 26MM SAPIEN XT VALVE HAD BEEN IMPLANTED IN A PRE-EXISTING PULMONIC BIOPROSTHETIC VALVE IN VALVE. PATIENT WITH HISTORY OF TRANSPOSITION OF GREAT VESSELS AND VENTRICULAR SEPTAL DEFECT STATUS POST REPAIR, PULMONARY HOMOGRAFT PLACEMENT X 3 FOR RIGHT VENTRICULAR OUTFLOW TRACT (RVOT) STENOSIS AND RECURRENT HOMOGRAFT FAILURE, TPVR PROCEDURES X3 (2 MELODY VALVES AND A 26 MM SAPIEN XT VALVE. APPROXIMATELY 6 YEARS AND 10 MONTHS POST IMPLANT, AN ECHOCARDIOGRAM REVEALED ELEVATED RIGHT VENTRICULAR PRESSURES AT 95MMHG AND PULMONARY STENOSIS; THE XT VALVE FUNCTION WAS UNABLE TO BE ASSESSED AS THE VALVE WAS NOT WELL VISUALIZED. THE PATIENT HAD MILD SYMPTOMS. APPROXIMATELY 8 MONTHS LATER, A CT STUDY PERFORMED REVEALED "EXTENSIVE STENT PLACEMENT IN THE RVOT WHICH PARTIALLY JAILS THE RIGHT PA (PULMONARY ARTERY) AND HAS IN PLACE A STENT-MOUNTED SAPIEN EDWARD'S VALVE WITH A MINIMUM DIAMET

  Patient problems: Insufficient Information

  MAUDE report 19542609 ↗
• InjuryApr 5, 2024Degraded; Degraded

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST, APPROXIMATELY 8 YEARS POST TRANSFEMORAL TAVR PROCEDURE WITH A 26 MM SAPIEN XT VALVE, THE VALVE FAILED DUE TO STENOSIS AND AORTIC INSUFFICIENCY. THE PATIENT IS SCHEDULED FOR VALVE-IN-VALVE PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 19055558 ↗
• InjuryMar 28, 2024Calcified; Insufficient Device Problem Information; Calcified; Insufficient Device Problem Information

  PER MEDICAL RECORD REVIEW A TTE PERFORMED APPROXIMATELY 7 YEARS AND 3 MONTHS POST TPVR SHOWED THE VALVE HAD SEVERE PV STENOSIS, MODERATE TO SEVERE REGURGITATION AND PV MEAN GRADIENT 52MMHG. THE VALVE WAS EXPLANTED AND FOUND TO BE HEAVILY CALCIFIED.

  Patient problems: Dyspnea; Insufficient Information

  MAUDE report 18991080 ↗