INSPIRIS RESILIA AORTIC VALVE 11500A (REF 11500A19)Recalls & reported problems

Summary

The FDA's MAUDE database contains 62 adverse event reports that list this exact device (DI 00690103194968), received between Feb 11, 2021 and May 8, 2026 — classified as 62 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (29 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 62 reports, in the reporter's own words as published by the FDA.

• InjuryMay 8, 2026Calcified

  IT WAS REPORTED THAT A PATIENT WITH A 19MM 11500A AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 3 YEARS AND 10 MONTHS DUE TO SEVERE STENOSIS, REGURGITATION, AND CALCIFICATION. THE PATIENT WAS PRESENTED WITH CHEST PAIN. THE TAVR WAS COMPLETED SUCCESSFULLY WITH A 20MM TRANSCATHETER VALVE.

  Patient problems: Chest Pain

  MAUDE report 25131163 ↗
• InjuryApr 29, 2026Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 19MM 11500A AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 2 YEARS DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH A 23MM 11500A VALVE. EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR SERIALIZED EDWARDS IMPLANTABLE DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET SURVEILLANCE REGISTRY. THROUGH THE REGISTRY, EDWARDS IS NOTIFIED WHEN THESE DEVICES ARE IMPLANTED. IN ADDITION, PATIENT AND/OR DEVICE STATUS MAY BE REPORTED TO THE REGISTRY VIA THE IMPLANTATION DATA CARDS. THE INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL, AND PATIENT FAMILY MEMBERS) AND IS NOT RECEIVED IN THE FORM OF A CONVENTIONAL 'CUSTOMER COMPLAINT'. THE INFORMATION REPORTED MAY OR MAY NOT BE RELATED TO THE EDWARDS DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 25033310 ↗
• InjuryApr 7, 2026Thickening of Material

  IT WAS REPORTED THAT A PATIENT WITH A 19MM 11500A AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 2 YEARS, 2 MONTHS DUE TO LEAFLET THICKENING, RESTRICTED MOTION, AND SEVERE STENOSIS. THE PATIENT PRESENTED WITH HEART FAILURE SYMPTOMS. A 23MM 11500A VALVE WAS IMPLANTED IN REPLACEMENT. THE PATIENT WAS SENT TO RECOVERY POST-PROCEDURE. PER MEDICAL RECORDS, THE PATIENT PRESENTED WITH PROGRESSIVE SHORTNESS OF BREATH SECONDARY TO DECOMPENSATED HEART FAILURE WITH PRESERVED EJECTION FRACTION (HFPEF). THE PATIENT IS TO FOLLOW UP FOR TAVR EVALUATION AND FOR FURTHER MANAGEMENT.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 24804320 ↗
• InjuryJan 9, 2026Adverse Event Without Identified Device or Use Problem; Device Stenosis

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 19MM 11500A AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 3 YEARS, 3 MONTHS DUE TO VEGETATION/ENDOCARDITIS. THE EXPLANTED VALVE WAS REPLACED WITH A 23MM 11500A INSPIRIS RESILIA AORTIC VALVE. PER MEDICAL RECORDS, TEE DEMONSTRATED RESTRICTED AORTIC VALVE LEAFLET OPENING WITH THICKENING OF LEAFLETS. PATIENT NOT CANDIDATE FOR VIV DUE TO SIGNIFICANT THROMBUS ON LEAFLETS. INTRAOPERATIVELY, SMALL POCKET OF PURULENT DRAINAGE WITH HEAVY AORTIC VALVE VEGETATION NOTED. SIGNIFICANT THROMBUS NOTED ON UNDERSIDE OF VALVE SUSPICIOUS FOR SMOLDERING INFECTION. VALVE WAS REMOVED AND SENT FOR CULTURE. ANNULUS WAS FULLY DEBRIDED AND A 23MM 11500A INSPIRIS VALVE WAS SUTURED INTO PLACE. PATIENT WAS TRANSPORTED IN STABLE CONDITION TO CICU AND DISCHARGED ON POD#8. THIS IS A 60-YEAR-OLD FEMALE PATIENT.

  Patient problems: Dyspnea; Endocarditis

  MAUDE report 24030671 ↗
• InjuryDec 23, 2025Degraded; Degraded

  IT WAS REPORTED THAT A PATIENT WITH A 19MM 11500A INSPIRIS RESILIA AORTIC VALVE, IMPLANTED IN THE PULMONARY POSITION, UNDERWENT A VALVE IN VALVE PROCEDURE AFTER IMPLANT DURATION OF 2 YEARS, 6 MONTHS DUE TO DEGENERATION, MODERATE STENOSIS AND MODERATE REGURGITATION. THE VALVE WAS REPLACED WITH A 23MM 9600TFX VALVE. THE PATIENT WAS STABLE POST-PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 23882395 ↗
• InjuryNov 3, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT WITH A 19MM 11500A AORTIC VALVE IS UNDER EVALUATION FOR A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF TWO (2) YEARS AND FIVE (5) MONTHS DUE TO HALT AND EARLY DEGENERATIVE AORTIC STENOSIS. THE PATIENT PRESENTED WITH ACUTE ON CHRONIC CHF. THE PROCEDURE WAS PERFORMED WITH A 23MM 9755RSL TRANSCATHETER VALVE. PER MEDICAL RECORDS, THE PATIENT WAS PLACED ON WARFARIN FOR HALT, AND NOT FOR AFIB. THIS IS A 80-YEAR-OLD FEMALE WITH A PAST MEDICAL HISTORY OF S/P AVR (B)(6) 2023), SEVERE TRICUSPID VALVE REGURGITATION, CORONARY ARTERY DISEASE S/P CABG X 3 (B)(6) 2023), ATRIAL FIBRILLATION WITH RVR S/P LAA LIGATION (B)(6) 2023), SUPRAVENTRICULAR TACHYCARDIA, PROLONGED QT (ON AMIODARONE), CHRONIC DIASTOLIC HEART FAILURE, HYPERTENSION, HYPERLIPIDEMIA, TACHY-BRADY SYNDROME S/P DUAL-CHAMBER PACEMAKER IMPLANTATION (B)(6) 2025), ASCENDING AORTA ANEURYSM.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 23459156 ↗
• InjurySep 2, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 19MM 11500A AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF (B)(6) DUE TO STENOSIS. THE PATIENT WAS PRESENTED WITH CONGESTIVE HEART FAILURE. THE TAVR WAS COMPLETED WITH A 9755RSL 23MM VALVE.

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

  MAUDE report 22948598 ↗
• InjuryAug 11, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A PATIENT WITH A 19MM 11500A AORTIC VALVE IS UNDER EVALUATION FOR A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF THREE (3) YEARS AND FIVE (5) MONTHS DUE TO SEVERE AS FROM PROSTHESIS MISMATCH. THE PATIENT PRESENTED WITH DYSPNEA AND FATIGUE. PER MEDICAL RECORDS, TTE ON (B)(6) 2025 SUGGESTIVE OF PPM. LVOT DIAMETER IS 1.7 CM. AV PEAK GRADIENT IS 61 MMHG. AV MEAN GRADIENT IS 35 MMHG. AV PEAK VELOCITY IS 3.9 111/S. AV AREA BY VTI IS 0.6 CM2. TEE ON (B)(6) 2025 SHOWED MILDLY ELEVATED GRADIENTS LIKELY FROM BEING UNDERSIZED WITH PPM.

  Patient problems: Dyspnea; Fatigue; Syncope/Fainting

  MAUDE report 22778292 ↗
• InjuryJul 14, 2025Intravalvular regurgitation; Intravalvular regurgitation

  IT WAS REPORTED THAT A PATIENT WITH A 19MM 11500A AORTIC VALVE, IMPLANTED IN THE PULMONARY POSITION, UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 3 YEARS, 5 MONTHS DUE TO REGURGITATION AND STENOSIS. THE PROCEDURE WAS PERFORMED WITH A 23MM 9600TFX TRANSCATHETER VALVE.

  Patient problems: Insufficient Information

  MAUDE report 22498173 ↗
• InjuryJun 27, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 19MM 11500A AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 6 YEARS, 1 MONTH DUE TO STENOSIS. THE PATIENT PRESENTED WITH SHORTNESS OF BREATH. THE TAVR PROCEDURE WAS SUCCESSFULLY PERFORMED WITH A 23MM 9755RSL VALVE. THE PATIENT WAS DISCHARGED ON POD #1.

  Patient problems: Insufficient Information

  MAUDE report 22346264 ↗
• InjuryJun 7, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 19MM 11500A AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 5 YEARS, 10 MONTHS DUE TO UNKNOWN REASON. THE AORTIC VALVE WAS REPLACED WITH A 19MM 11500A VALVE. THE PATIENT WAS IN RECOVERY POST PROCEDURE. THE PATIENT CONCOMITANTLY UNDERWENT A MVR WITH A 25MM 11400M VALVE. EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR SERIALIZED EDWARDS IMPLANTABLE DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET SURVEILLANCE REGISTRY. THROUGH THE REGISTRY, EDWARDS IS NOTIFIED WHEN THESE DEVICES ARE IMPLANTED. IN ADDITION, PATIENT AND/OR DEVICE STATUS MAY BE REPORTED TO THE REGISTRY VIA THE IMPLANTATION DATA CARDS. THE INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL, AND PATIENT FAMILY MEMBERS) AND IS NOT RECEIVED IN THE FORM OF A CONVENTIONAL CUSTOMER COMPLAINT. THE INFORMATION REPORTED MAY OR MAY NOT BE RELATED TO THE EDWARDS DEVICE.

  Patient problems: Fever; Insufficient Information

  MAUDE report 22163653 ↗
• InjuryMay 9, 2025Degraded; Patient Device Interaction Problem; Degraded; Patient Device Interaction Problem

  IT WAS LEARNED VIA IMPLANT PATIENT REGISTRY THAT A 11500A 19MM AORTIC VALVE WAS EXPLANTED AND REPLACED WITH A 11500A 23MM AFTER AN IMPLANT DURATION OF 5 YEARS, 9 MONTHS DUE TO DEGENERATION, PANNUS, STENOSIS, AND REGURGITATION. THE PATIENT PRESENTED WITH HF AND SOB. EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR SERIALIZED EDWARDS IMPLANTABLE DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET SURVEILLANCE REGISTRY. THROUGH THE REGISTRY, EDWARDS IS NOTIFIED WHEN THESE DEVICES ARE IMPLANTED. IN ADDITION, PATIENT AND/OR DEVICE STATUS MAY BE REPORTED TO THE REGISTRY VIA THE IMPLANTATION DATA CARDS. THE INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL AND PATIENT FAMILY MEMBERS) AND IS NOT RECEIVED IN THE FORM OF A CONVENTIONAL "CUSTOMER COMPLAINT." THE INFORMATION REPORTED MAY OR MAY NOT BE RELATED TO THE EDWARDS DEVICE.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 21996212 ↗
• InjuryApr 23, 2025Degraded; Patient-Device Incompatibility; Insufficient Device Problem Information; Degraded; Patient-Device Incompatibility; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT WITH A 19MM 11500A VALVE, IMPLANTED IN AORTIC POSITION, UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 2 YEARS AND 8 MONTHS DUE TO STENOSIS.

  Patient problems: Chest Pain; Dyspnea; Insufficient Information

  MAUDE report 21894295 ↗
• InjuryApr 22, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A PATIENT WITH A 19MM 11500A AORTIC VALVE, WAS EXPLANTED AFTER AN IMPLANT DURATION OF 5 YEARS, 3 MONTHS DUE TO REGURGITATION. THE PATIENT PRESENTED WITH HEART FAILURE AND CARDIOGENIC SHOCK. THE EXPLANTED VALVE WAS REPLACED WITH A 27MM 11500A AORTIC VALVE. THE PATIENT WAS TRANSFERRED TO THE ICU POST-PROCEDURE AND WAS DISCHARGED ON (B)(6). EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR SERIALIZED EDWARDS IMPLANTABLE DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET SURVEILLANCE REGISTRY. THROUGH THE REGISTRY, EDWARDS IS NOTIFIED WHEN THESE DEVICES ARE IMPLANTED. IN ADDITION, PATIENT AND/OR DEVICE STATUS MAY BE REPORTED TO THE REGISTRY VIA THE IMPLANTATION DATA CARDS. THE INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL, AND PATIENT FAMILY MEMBERS) AND IS NOT RECEIVED IN THE FORM OF A CONVENTIONAL "CUSTOMER COMPLAINT". THE INFORMATION REPORTED MAY OR MAY NOT BE RELATED TO THE EDWARDS DEVICE.

  Patient problems: Cardiogenic Shock; Heart Failure/Congestive Heart Failure

  MAUDE report 21886337 ↗
• InjuryMar 27, 2025Degraded; Intravalvular regurgitation; Degraded; Intravalvular regurgitation

  IT WAS REPORTED AND LEARNED THROUGH MEDICAL RECORDS THAT A PATIENT WITH A 19MM 11500A AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 3 YEARS, 11 MONTHS DUE TO SEVERE REGURGITATION SECONDARY TO VALVE DETERIORATION. THE PATIENT PRESENTED WITH CHF, SOB AND EDEMA. THE PROCEDURE WAS PERFORMED WITH A 20MM 9755RSL TRANSCATHETER VALVE. THE PATIENT WAS TAKEN TO RECOVERY IN STABLE CONDITION POST PROCEDURE. THE PATIENT WAS DISCHARGED POD #2. PER MEDICAL RECORDS, THE PATIENT PRESENTED WITH CHF, SOB AND EDEMA. ECHO CONFIRMED SEVERE AORTIC REGURGITATION D/T VALVE DETERIORATION AND MILD TO MODERATE MITRAL PVL. PATIENT UNDERWENT TAVR PROCEDURE WITH 20MM ULTRA RESILIA. VALVE WAS DEPLOYED WITHOUT COMPLICATION AND TEE CONFIRMED APPROPRIATE PLACEMENT, NORMAL GRADIENT, AND NO PVL. THE PATIENT WAS TAKEN TO RECOVERY IN STABLE CONDITION POST PROCEDURE. THE PATIENT WAS DISCHARGED POD #2.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 21710762 ↗
• InjuryMar 23, 2025Insufficient Device Problem Information; Intravalvular regurgitation; Insufficient Device Problem Information; Intravalvular regurgitation

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 19MM 11500A AORTIC VALVE IN AORTIC POSITION WAS EXPLANTED AND REPLACED WITH A 21MM 11060A KONECT VALVED CONDUIT AFTER AN IMPLANT DURATION OF 1 YEAR, 2 MONTHS AND 14 DAYS DUE TO MODERATE TO SEVERE AORTIC REGURGITATION. THE PATIENT PRESENTED WITH DYSPNEA. INTRAOPERATIVELY, A CAVITY WAS NOTED ADJACENT TO WHERE THE RIGHT CORONARY OSTIUM WOULD BE. THE SURGEON NOTED THAT THIS WAS LIKELY A HEMATOMA SECONDARY TO THE PRIOR ROOT ENLARGEMENT. AN INCREDIBLE AMOUNT OF INFLAMMATION WAS NOTED THROUGHOUT THE AORTIC ROOT. A 21MM 11060A VALVED AORTIC CONDUIT WAS SUTURED INTO PLACE. THERE WAS DIFFICULTY COMING OFF CBP AND PATIENT WAS PLACED ON ECMO. HEMOSTASIS WAS OBTAINED AND PATIENT WAS TAKEN TO THE ICU IN CRITICAL CONDITION. PATIENT DISCHARGED ON POD#3. PER PATHOLOGY, EXPLANTED AORTIC VALVE HAD NO VEGETATIONS, TEARS, OR CALCIFICATIONS ALONG THE VALVE CUSPS.

  Patient problems: Dyspnea; Insufficient Information

  MAUDE report 21674610 ↗
• InjuryMar 19, 2025Calcified; Patient Device Interaction Problem; Device Stenosis; Calcified; Patient Device Interaction Problem; Device Stenosis

  IT WAS REPORTED AND LEARNED THROUGH INVESTIGATION THAT A PATIENT WITH A 19MM 11500A AORTIC VALVE HAS BEEN PLACED UNDER EVALUATION FOR A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 6 YEARS, 2 MONTHS DUE TO STENOSIS. THE PATIENT PRESENTED WITH SOB.

  Patient problems: Dyspnea

  MAUDE report 21646117 ↗
• InjuryMar 5, 2025Calcified; Gradient Increase; Calcified; Gradient Increase

  IT WAS REPORTED THAT A PATIENT WITH A 19MM 11500A INSPIRIS VALVE WAS FOUND TO HAVE SYMPTOMATIC HIGH GRADIENTS AFTER AN APPROXIMATE IMPLANT DURATION OF SIX (5) YEARS WITH INCREASED GRADIENTS, MODERATELY THICKENED AND CALCIFIED LEAFLETS, MODERATE STENOSIS, AND TRACE REGURGITATION. THE PATIENT WAS NOTED TO BE ON ANTICOAGULATION MEDICATION AND IS BEING MONITORED. PER MEDICAL RECORDS, ON (B)(6) 2024 THE PATIENT HAD INCREASING GRADIENT, WAS STARTED ON ANTICOAGULATION FOR POTENTIAL THROMBUS, BUT WAS UNABLE TO TOLERATE IT. THE PATIENT WAS THEN GIVEN ASPIRIN AND CLOPIDOGREL. ECHO ON (B)(6) 2024 SHOWED, PROSTHETIC AV LEAFLETS ARE MODERATELY THICKENED AND MODERATELY CALCIFIED. THERE WAS CONCERN FOR PPM VS HALT BUT HAD CT SCAN WHICH WAS NEGATIVE FOR HALT.

  Patient problems: Insufficient Information

  MAUDE report 21528593 ↗
• InjuryMar 3, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 19MM 11500A AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 5 MONTHS DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH A 19MM 11500A VALVE. EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR SERIALIZED EDWARDS IMPLANTABLE DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET SURVEILLANCE REGISTRY. THROUGH THE REGISTRY, EDWARDS IS NOTIFIED WHEN THESE DEVICES ARE IMPLANTED. IN ADDITION, PATIENT AND/OR DEVICE STATUS MAY BE REPORTED TO THE REGISTRY VIA THE IMPLANTATION DATA CARDS. THE INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL, AND PATIENT FAMILY MEMBERS) AND IS NOT RECEIVED IN THE FORM OF A CONVENTIONAL 'CUSTOMER COMPLAINT'. THE INFORMATION REPORTED MAY OR MAY NOT BE RELATED TO THE EDWARDS DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 21507960 ↗
• InjuryDec 3, 2024Insufficient Device Problem Information; Device Stenosis; Insufficient Device Problem Information; Device Stenosis

  IT WAS REPORTED AND LEARNED THROUGH RECORDS THAT A PATIENT WITH A 19MM 11500A AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF TWO (2) YEARS, THREE (3) MONTHS DUE TO SEVERE STENOSIS. THE PATIENT PRESENTED WITH ACUTE ON CHRONIC HFPEF NYHA II. THE TAVR WAS PERFORMED WITH A 23MM NON-EDWARDS DEVICE. THE PATIENT WAS TRANSPORTED TO CVU WITHOUT COMPLICATIONS AND WAS DISCHARGED ON POD #1.

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

  MAUDE report 20833425 ↗
• InjuryNov 27, 2024Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A 19MM 11500A AORTIC VALVE IN AORTIC POSITION WAS DISABLED VIA VALVE IN VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 4 YEARS, 7 MONTHS DUE TO AORTIC STENOSIS. THE PATIENT PRESENTED WITH SHORTNESS OF BREATH AND FATIGUE. TAVR WAS PERFORMED WITH A 20MM 9750TFX TRANSCATHETER VALVE AND THE PATIENT WAS STABLE AT THE END OF THE PROCEDURE.

  Patient problems: Dyspnea; Fatigue

  MAUDE report 20799321 ↗
• InjuryNov 22, 2024Insufficient Device Problem Information; Device Stenosis; Insufficient Device Problem Information; Device Stenosis

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 19MM 11500A AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF FOUR (4) YEARS AND NINE (9) MONTHS DUE TO UNKNOWN REASON. THE EXPLANTED DEVICE WAS REPLACED WITH A 23MM 11500A AORTIC VALVE. EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR SERIALIZED EDWARDS IMPLANTABLE DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET SURVEILLANCE REGISTRY. THROUGH THE REGISTRY, EDWARDS IS NOTIFIED WHEN THESE DEVICES ARE IMPLANTED. IN ADDITION, PATIENT AND/OR DEVICE STATUS MAY BE REPORTED TO THE REGISTRY VIA THE IMPLANTATION DATA CARDS. THE INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL, AND PATIENT FAMILY MEMBERS) AND IS NOT RECEIVED IN THE FORM OF A CONVENTIONAL "CUSTOMER COMPLAINT". THE INFORMATION REPORTED MAY OR MAY NOT BE RELATED TO THE EDWARDS DEVICE.

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

  MAUDE report 20758341 ↗
• InjuryNov 17, 2024Intravalvular regurgitation; Intravalvular regurgitation

  IT WAS REPORTED AND LEARNED THROUGH INVESTIGATION THAT A 19MM 11500A AORTIC VALVE, IMPLANTED IN THE PULMONIC POSITION UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF THREE (3) YEARS AND ONE (1) MONTH DUE TO INSUFFICIENCY. A TPVR WAS PERFORMED WITH A NON-EDWARDS DEVICE. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TAKEN TO RECOVERY IN STABLE CONDITION. PER MEDICAL RECORDS, PATIENT DID NOT EXPERIENCE ANY ACUTE SYMPTOMS AND WAS NOTED TO BE KEEPING UP WITH ACTIVITIES. ECHO REVEALED FREE PULMONARY VALVE INSUFFICIENCY. THE TPVR PROCEDURE WAS SUCCESSFUL AND THERE WAS NO POST-PROCEDURE REGURGITATION PRESENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20702672 ↗
• InjuryNov 6, 2024Inadequacy of Device Shape and/or Size; Patient Device Interaction Problem; Inadequacy of Device Shape and/or Size; Patient Device Interaction Problem

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND MEDICAL RECORDS THAT A PATIENT WITH A 19MM 11500A AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 1 YEARS, 7 MONTHS DUE TO PATIENT PROTHESIS MISMATCH AND PANNUS. PATIENT PRESENTED IN ACUTE ON CHRONIC BIVENTRICULAR SYSTOLIC HEART FAILURE. THE EXPLANTED VALVE WAS REPLACED WITH A 23MM 11500A AORTIC VALVE. PER MEDICAL RECORDS, INTRAOPERATIVELY, UPON INSPECTION OF THE 19MM 11500A VALVE, THERE WAS SIGNIFICANT PANNUS, AND THE VALVE WAS NOTED TO BE VERY INCORPORATED INTO THE ANNULUS AND ANTERIOR MITRAL LEAFLET. THE VALVE WAS RESECTED. THE AREA WAS DENUDED, AND PROLENE SUTURES WERE USED TO CREATE A NEO ANNULUS. A PARTIAL MYOMECTOMY WAS PERFORMED TO OPEN THE LVOT. SURGEON PROCEEDED TO REPLACE THE MITRAL VALVE. UPON SEATING OF A 31MM MITRIS, SURGEON NOTED THAT IT WAS TOO BULKY FOR THE PATIENT SMALL ANATOMY. THE SURGEON REMOVED THE MITRIS VALVE AND DOWNSIZED TO A NON-EDWARDS VALVE. THE AORTO-MITRAL CURTAIN WAS RECONSTRUCTED, AND THE AORTIC VALVE WAS SIZED TO A 23MM 11500A VALVE. THE VALVE WAS SUTURED IN PLACE WITH GOOD RESULT. SURGEON ALSO PERFORMED TRICUSPID VALVE REPAIR WITH A NON-EDWARDS RING. POST-BYPASS, PATIENT EXPERIENCED COAGU

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 20622175 ↗
• InjuryOct 27, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 19MM 11500A AORTIC VALVE IN AORTIC POSITION WAS EXPLANTED AFTER AN IMPLANT DURATION OF 2 YEARS, 5 MONTHS DUE TO UNKNOWN REASON. AVR WAS COMPLETED WITH AN UNKNOWN VALVE. EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR SERIALIZED EDWARDS IMPLANTABLE DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET SURVEILLANCE REGISTRY. THROUGH THE REGISTRY, EDWARDS IS NOTIFIED WHEN THESE DEVICES ARE IMPLANTED. IN ADDITION, PATIENT AND/OR DEVICE STATUS MAY BE REPORTED TO THE REGISTRY VIA THE IMPLANTATION DATA CARDS. THE INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL, AND PATIENT FAMILY MEMBERS) AND IS NOT RECEIVED IN THE FORM OF A CONVENTIONAL "CUSTOMER COMPLAINT". THE INFORMATION REPORTED MAY OR MAY NOT BE RELATED TO THE EDWARDS DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 20541630 ↗