INSPIRIS RESILIA AORTIC VALVE 11500A (REF 11500A27)Recalls & reported problems

Summary

The FDA's MAUDE database contains 158 adverse event reports that list this exact device (DI 00690103195002), received between Nov 7, 2021 and Sep 18, 2026 — classified as 2 deaths, 155 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (96 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 158 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 2026Device Stenosis

  It was reported and later learned that a patient with a 27mm 11500A Inspiris Resilia aortic valve in aortic position underwent a valve in valve procedure after an implant duration of 7 years, 4 months due to stenosis. TAVR was completed with a 26mm 9755RSL transcatheter valve.

  Patient problems: Insufficient Information

  MAUDE report 50812918 ↗
• InjuryAug 23, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  It was learned through Implant Patient Registry that a patient with a 27mm 11500A aortic valve was explanted after an implant duration of 7 years, 9 months due to unknown reasons. The explanted valve was replaced with a 25mm 11060A valved conduit.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: Endocarditis; Insufficient Information

  MAUDE report 50396499 ↗
• InjuryMay 11, 2026Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 27MM 11500A VALVE, IMPLANTED IN PULMONIC POSITION, UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 6 YEARS AND 4 MONTHS DUE TO STENOSIS. THE PATIENT WAS STABLE AND SENT TO RECOVERY POST PROCEDURE. THE TPVR WAS COMPLETED SUCCESSFULLY WITH A 9600TFX 29MM TRANSCATHETER VALVE.

  Patient problems: Dyspnea; Insufficient Information

  MAUDE report 25145214 ↗
• InjuryApr 29, 2026Patient-Device Incompatibility

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A PATIENT WITH A 27MM 11500A AORTIC VALVE WAS EXPLANTED AT IMPLANT TO REPAIR DISRUPTION OF THE AORTIC SUTURE LINE. THE EXPLANTED VALVE WAS REPLACED WITH A 27MM 11500A VALVE. THE PATIENT WAS IN RECOVERY POST PROCEDURE. PER MEDICAL RECORDS, THE PATIENT HAD SEVERE NATIVE AI/AS WITH HEART FAILURE. THE PATIENT INITIALLY UNDERWENT AVR WITH A 27MM 11500A VALVE AND AN IABP WAS PLACED TO HELP SUPPORT WEANING FROM THE BYPASS. PRIOR TO WEANING FROM BYPASS, THERE WAS SOME BLEEDING FROM THE AORTIC SUTURE LINE THAT WAS REPAIRED WITH PLEDGETED SUTURES. INTRAOPERATIVELY, PATIENT HAD VERY FRAGILE AND FRIABLE TISSUE WITH HEAVY CALCIFICATION OF THE NATIVE AORTIC VALVE. BUT AFTER COMING OFF BYPASS, THERE WAS PARTIAL DISRUPTION OF THE AORTIC SUTURE LINE THAT WAS NOT AMENDABLE TO REPAIR OFF PUMP. CPB WAS PLACED BACK AND A BENTALL PROCEDURE WAS PERFORMED. THE 27MM 11500A VALVE WAS EXPLANTED. THERE WAS NOTED TO BE PARTIAL SEPARATION OF THE ANTERIOR MITRAL LEAFLET NEAR ITS INSERTION, DEMONSTRATING HOW FRAGILE THE PATIENT'S TISSUE WAS AFTER SEATING THE PREVIOUS VALVE. A NEW 27 MM INSPIRIS VALVE WAS IMPLANTED, AND A 32 MM CARDIA ROOT WAS

  Patient problems: Laceration(s)

  MAUDE report 25029691 ↗
• InjuryApr 23, 2026Calcified

  IT WAS REPORTED AND LEARNED THROUGH INVESTIGATION. A PATIENT WITH A 27MM 11500A AORTIC VALVE IMPLANTED FIVE (5) YEARS, EIGHT (8) MONTHS, UNDERWENT VALVE-IN-VALVE PROCEDURE DUE TO STENOSIS AND CALCIFICATION. PATIENT PRESENTED WITH SHORTNESS OF BREATH. TAVR WAS SUCCESSFULLY PERFORMED WITH A 29MM 9755RSL TRANSCATHETER VALVE. PATIENT WAS STABLE AT THE END THE OF THE PROCEDURE.

  Patient problems: Dyspnea

  MAUDE report 24974583 ↗
• InjuryApr 15, 2026Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 27MM 11500A AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 2 YEARS, 8 MONTHS DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH A 27MM 11500A VALVE. A 33MM 11400M VALVE WAS IMPLANTED CONCOMITANTLY. 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 24891388 ↗
• InjuryApr 13, 2026Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 27MM 11500A AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 4 YEARS DUE TO UNKNOWN REASON. 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 24865920 ↗
• InjuryMar 25, 2026Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 27MM 11500A AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 4 YEARS AND 10 MONTHS DUE TO UNKNOWN REASON. THE VALVE WAS REPLACED WITH A 11060A 27MM VALVED CONDUIT.

  Patient problems: Insufficient Information

  MAUDE report 24684264 ↗
• InjuryMar 15, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A 27MM 11500A AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF SEVEN (7) MONTHS, AND 14 DAYS DUE TO ENDOCARDITIS. THE EXPLANTED VALVE WAS REPLACED WITH A 25MM 11060A AORTIC VALVE.

  Patient problems: Endocarditis; Insufficient Information

  MAUDE report 24602136 ↗
• InjuryMar 11, 2026Insufficient Device Problem Information

  IT WAS LEARNED THROUGH THE IMPLANT PATIENT REGISTRY THAT A 27MM 11500A AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 11 MONTHS DUE TO UNKNOWN REASON. THE VALVE WAS REPLACED WITH A 29MM 11500A BIOPROSTHETIC VALVE.

  Patient problems: Endocarditis; Insufficient Information

  MAUDE report 24565971 ↗
• InjuryMar 10, 2026Patient-Device Incompatibility

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A PATIENT WITH A 27MM 11500A AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 5 DAYS DUE TO ACUTE OCCLUSION OF THE LEFT MAIN CORONARY ARTERY CAUSED BY A CLOT. THE EXPLANTED VALVE WAS REPLACED WITH A 23MM 11500A VALVE. PER MEDICAL RECORDS, ON POST-OP DAY 5 THE PATIENT DEVELOPED DIZZINESS AND WENT INTO CARDIAC ARREST, WAS RESUSCITATED AND PLACED ON VA-ECMO. HEART CATH SHOWED ACUTE OCCLUSION OF LMCA, AND VALVE ITSELF SEEMED TO BE IMPINGING ON THE LM. THE PATIENT WAS EMERGENTLY TAKEN TO THE OR FOR CABG VS REDO AVR. INTRAOPERATIVELY THE VALVE WAS REMOVED AND AT THE OPENING OF THE LMCA A CLOT WAS IDENTIFIED AND REMOVED. DECISION WAS MADE TO DOWNSIZE THE VALVE, A 25MM SIZER WOULD NOT ADVANCE THROUGH. THUS, A SIZE 23MM VALVE WAS SELECTED AND IMPLANTED WITH NON-PLEDGETED SUTURES AND LOWERED AND SECURE IN PLACE. THE LEFT MAIN WAS ACCESSIBLE WITH A RIGHT-ANGLE CLAMP WITH EASE. AFTER HEMOSTASIS WAS SATISFACTORY, THE PATIENT WAS TRANSPORTED BACK TO THE LCU IN STABLE BUT CRITICAL CONDITION ON VA ECMO AND IABP. ON POD #36, THE PATIENT WAS DISCHARGED. EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY. THIS REGIS

  Patient problems: Coronary obstruction/occlusion

  MAUDE report 24564959 ↗
• InjuryFeb 13, 2026Insufficient Device Problem Information

  IT WAS LEARNED VIA THE PATIENT REGISTRY THAT A PATIENT WITH A 27MM 11500A INSPIRIS VALVE UNDERWENT REDO AORTIC VALVE REPLACEMENT AFTER AN IMPLANT DURATION OF FOUR (4) YEARS, 11 MONTHS DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH A 25MM 11500A INSPIRIS 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 24339041 ↗
• InjuryFeb 8, 2026Calcified

  IT WAS REPORTED THAT A PATIENT WITH A 27MM 11500A AORTIC VALVE UNDERWENT AN EMERGENT VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF FOUR (4) YEARS, SIX (6) MONTHS DUE TO CALCIFICATION AND CRITICAL STENOSIS. THE PATIENT WAS INITIALLY ADMITTED FOR CARDIOGENIC SHOCK, ACUTE ON CHRONIC HFREF SECONDARY TO STENOSIS. THE PROCEDURE WAS PERFORMED WITH A 29MM NON-EDWARDS TRANSCATHETER VALVE.

  Patient problems: Cardiogenic Shock

  MAUDE report 24288426 ↗
• InjuryFeb 6, 2026Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 27MM 11500A AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 4 YEARS, 11 MONTHS DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH A 27MM 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 24281059 ↗
• InjuryFeb 6, 2026Degraded

  IT WAS REPORTED THAT A PATIENT WITH A 27MM 11500A INSPIRIS VALVE IN THE PULMONARY POSITION UNDERWENT VALVE-IN-VALVE INTERVENTION AFTER AN IMPLANT DURATION OF SIX (6) YEARS, 11 MONTHS DUE TO SEVERE PULMONARY INSUFFICIENCY SECONDARY TO DEGENERATION. THE PATIENT INITIALLY PRESENTED WITH SHORTNESS OF BREATH. THE TPVR PROCEDURE WAS SUCCESSFULLY PERFORMED WITH 26MM 9755RSL TRANSCATHETER VALVE. THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: Dyspnea

  MAUDE report 24280850 ↗
• InjuryFeb 2, 2026Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 27MM 1500A INSPIRIS RESILIA AORTIC VALVE IN AORTIC POSITION WAS EXPLANTED AFTER AN IMPLANT DURATION OF 4 YEARS, 9 MONTHS DUE TO UNKNOWN REASON. 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 24233549 ↗
• InjuryJan 23, 2026Degraded; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 27MM 11500A VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 7 YEARS DUE TO DEGENERATION, STENOSIS AND INSUFFICIENCY. THE PATIENT PRESENTED WITH SYMPTOMS OF HEART FAILURE. THE TAVR PROCEDURE WAS SUCCESSFULLY PERFORMED WITH A 26MM 9755RSL VALVE. THE PATIENT WAS STABLE POST PROCEDURE AND DISCHARGED ON POD #1.

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

  MAUDE report 24164942 ↗
• InjuryJan 15, 2026Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 27MM 11500A AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 2 YEARS, 5 MONTHS DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH A 25MM 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 24082647 ↗
• InjuryJan 14, 2026Insufficient Device Problem Information

  IT WAS LEARNED THROUGH THE IMPLANT PATIENT REGISTRY A 27MM 11500 AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 3 MONTHS DUE TO UNKNOWN REASON. THE VALVE WAS REPLACED WITH A 23MM 11060A VALVE.

  Patient problems: Insufficient Information

  MAUDE report 24076797 ↗
• InjuryJan 9, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 27MM 11500A AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 3 YEARS, 5 MONTHS DUE TO ENDOCARDITIS. THE EXPLANTED VALVE WAS REPLACED WITH A 27MM 11060A VALVED CONDUIT. PER MEDICAL RECORDS, INTRAOPERATIVELY, AORTIC VALVE NOTED TO HAVE SIGNIFICANT VEGETATION WITH A CLEAR AORTIC ROOT ABSCESS. AORTIC VALVE NOTED TO BE COMPLETELY DEHISCED WITH CONTAINED RUPTURE IN THE SINUSES. THE PATIENT SURROUNDING TISSUE WAS NOTED TO BE VERY FRIABLE. A 27MM 11060A VALVED AORTIC CONDUIT WAS USED TO REPLACE THE AORTIC VALVE, WITH GOOD POSITIONING. THE PATIENT WAS TAKEN TO CVICU IN STABLE BUT GUARDED CRITICAL CONDITION AND DISCHARGED ON POD#12. 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

  Patient problems: Endocarditis; Insufficient Information

  MAUDE report 24029808 ↗
• InjuryDec 30, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED VIA THE IMPLANT PATIENT REGISTRY THAT THIS DEVICE MODEL 11500A 27MM AORTIC VALVE WAS EXPLANTED AND REPLACED WITH A 11500A 25MM AFTER AN IMPLANT DURATION OF 1 YEAR, 2 MONTHS DUE TO UNKNOWN REASONS. THE PATIENT WAS ALIVE. 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 23931180 ↗
• InjuryDec 22, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED VIA THE IMPLANT PATIENT REGISTRY THAT A 27MM 11500A AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF THREE (3) MONTHS, 18 DAYS DUE TO UNKNOWN REASON. THE EXPLANTED VALVE WAS REPLACED WITH ANOTHER 27MM 11500A VALVE. THE IMPLANTATION DATA CARD INDICATED THAT THE PATIENT WAS TAKEN TO RECOVERY POST PROCEDURE. 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 23872178 ↗
• InjuryDec 15, 2025Intravalvular regurgitation; Intravalvular regurgitation

  IT WAS REPORTED THAT A PATIENT WITH A 27MM 11500A VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 6 YEARS 10 MONTHS DUE TO REGURGITATION. THE PATIENT PRESENTED WITH DYSPNEA AND FATIGUE. THE TAVR WAS PERFORMED WITH A 26MM 9755RSL VALVE. THE PATIENT WAS STABLE AND IN RECOVERY POST PROCEDURE. THE PATIENT WAS DISCHARGED ON POD #1.

  Patient problems: Dyspnea; Fatigue

  MAUDE report 23804885 ↗
• InjuryDec 8, 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 AND INVESTIGATION THAT A PATIENT WITH A 27MM 11500A AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 2 YEARS, 7 MONTHS DUE TO ENDOCARDITIS. THE EXPLANTED VALVE WAS REPLACED WITH A 27MM 11500A VALVE. PER PATHOLOGY REPORT, PATIENT WAS DIAGNOSED WITH BACTEREMIA AND ACUTE BACTERIAL ENDOCARDITIS.

  Patient problems: Endocarditis; Insufficient Information

  MAUDE report 23748067 ↗
• InjuryDec 5, 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 AND INVESTIGATION THAT A PATIENT WITH A 27MM 11500A AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 2 YEARS, 1 MONTH DUE TO ENDOCARDITIS. THE EXPLANTED VALVE WAS REPLACED WITH A 27MM 11500A VALVE. THE PATIENT WAS IN RECOVERY POST PROCEDURE. PER MEDICAL RECORDS, PATIENT PRESENTED WITH UTI WITH BLOOD CULTURES POSITIVE FOR ENTEROCOCCUS FAECALIS. TEE DEMONSTRATED AORTIC VALVE VEGETATION WITH PERIANNULAR ABSCESS. INTRAOPERATIVELY, AORTIC VALVE WAS REMOVED AND ANNULUS WAS DEBRIDED. PURULENT DRAINAGE NOTED, AND ABSCESS POCKET WAS DEBRIDED. ABSCESS CAVITY EXTENDED DOWN TO LEFT MAIN ANNULUS AROUND THE NONCORONARY. A 27MM 11500A VALVE WAS SUTURED INTO PLACE AND THE PATIENT WAS WEANED AND THE VALVE SEATED WELL WITH NO PVL.

  Patient problems: Endocarditis; Insufficient Information

  MAUDE report 23735264 ↗