INSPIRIS RESILIA AORTIC VALVE 11500A (REF 11500A29)Recalls & reported problems

Summary

The FDA's MAUDE database contains 73 adverse event reports that list this exact device (DI 00690103195019), received between Apr 30, 2021 and Sep 30, 2026 — classified as 72 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (53 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 73 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Insufficient Device Problem Information

  Patient problems: Insufficient Information

  MAUDE report 50947063 ↗
• InjuryMay 1, 2026Adverse 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 29MM 11500A AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 5 YEARS, 6 MONTHS DUE TO ENDOCARDITIS. THE EXPLANTED VALVE WAS REPLACED WITH A 25MM 11060A VALVE. PER PATHOLOGY REPORT NOTED ENDOCARDITIS OF PROSTHETIC AORTIC VALVE.

  Patient problems: Endocarditis; Insufficient Information

  MAUDE report 25061315 ↗
• InjuryMar 31, 2026Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 29MM 11500A AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 5 YEARS AND 4 MONTHS DUE TO UNKNOWN REASON. THE VALVE WAS REPLACED WITH A 27MM 11500A VALVE.

  Patient problems: Insufficient Information

  MAUDE report 24744304 ↗
• InjuryMar 24, 2026Insufficient Device Problem Information

  IT WAS LEARNED VIA THE PATIENT REGISTRY THAT A PATIENT WITH A 29MM 11500A INSPIRIS VALVE IN THE AORTIC POSITION UNDERWENT REDO AORTIC VALVE REPLACEMENT AFTER AN IMPLANT DURATION OF FIVE (5) MONTHS DUE TO UNKNOWN REASONS. THE REPLACEMENT DEVICE IS UNKNOWN. 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 24681733 ↗
• InjuryMar 20, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A 29MM 11500A AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF THREE (3) YEARS, AND 10 MONTHS DUE TO ENDOCARDITIS (S. AUREUS). THE EXPLANTED VALVE WAS REPLACED WITH A 27MM 11060A AORTIC VALVED CONDUIT.

  Patient problems: Endocarditis; Insufficient Information

  MAUDE report 24651210 ↗
• InjuryFeb 27, 2026Insufficient Device Problem Information

  IT WAS LEARNED VIA THE PATIENT REGISTRY THAT A PATIENT WITH A 29MM 11500A INSPIRIS VALVE UNDERWENT REDO AORTIC VALVE REPLACEMENT AFTER AN IMPLANT DURATION OF THREE (3) YEARS, SIX (6) MONTHS DUE TO UNKNOWN REASONS. THE REPLACEMENT DEVICE IS UNKNOWN. 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 24472524 ↗
• InjuryFeb 13, 2026Intravalvular regurgitation

  IT WAS REPORTED THAT A PATIENT WITH A 29MM 11500A VALVE, IMPLANTED IN THE PULMONIC POSITION, UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 4 YEARS, 7 MONTHS DUE TO SEVERE PULMONIC INSUFFICIENCY. THE PATIENT PRESENTED WITH EXERCISE INTOLERANCE. THE TPVR WAS SUCCESSFULLY PERFORMED WITH A 29MM 9755RSL VALVE. PER MEDICAL RECORDS, THE PATIENT UNDERWENT TPVR/VIV AND THE SURGICAL VALVE RING WAS SUCCESSFULLY FRACTURED WITH A 28MM TRUE BALLOON AND 10MM ADVANCE 35 LP BALLOONS. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TRANSFERRED TO RECOVERY ROOM POST PROCEDURE. ON POD #1, THE PATIENT WAS DISCHARGED HOME.

  Patient problems: Fatigue

  MAUDE report 24339669 ↗
• InjuryFeb 13, 2026Calcified; Product Quality Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  PER THE REPORT RECEIVED FROM GERMANY, EDWARDS RECEIVED NOTIFICATION THAT THIS 11500A29 VALVE IMPLANTED IN AORTIC POSITION WAS EXPLANTED AFTER AN IMPLANT DURATION OF SEVEN (7) YEARS AND SIX (6) MONTHS DUE TO LEAFLET ALLEGEDLY DEFECTIVE. AS REPORTED, THE PATIENT WAS NOTED AS TO BE DOING FINE.

  Patient problems: Insufficient Information

  MAUDE report 24331074 ↗
• InjuryJan 30, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 29MM 11500A AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 5 MONTHS, 4 DAYS DUE TO UNKNOWN REASON. THE EXPLANTED VALVE WAS REPLACED WITH A 29MM 11500A VALVE. THE PATIENT WAS IN 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: Endocarditis; Insufficient Information; Thrombosis/Thrombus

  MAUDE report 24228681 ↗
• InjuryDec 27, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 29MM 11500A AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 1 YEARS, 2 MONTHS DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH A 29MM 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: Insufficient Information

  MAUDE report 23901493 ↗
• InjuryDec 20, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A 29MM 11500A AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF FIVE (5) YEARS, AND ONE (1) MONTH DUE TO UNKNOWN REASON. THE EXPLANTED VALVE WAS REPLACED WITH A 29MM 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: Insufficient Information

  MAUDE report 23860148 ↗
• InjuryDec 19, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED VIA THE PATIENT REGISTRY THAT A PATIENT WITH A 29MM 11500A INSPIRIS VALVE UNDERWENT REDO AORTIC VALVE REPLACEMENT AFTER AN IMPLANT DURATION OF TWO (2) YEARS, EIGHT (8) MONTHS DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH A 27MM 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 23854565 ↗
• InjuryDec 3, 2025Intravalvular regurgitation; Intravalvular regurgitation

  IT WAS REPORTED AND LEARNED THROUGH INVESTIGATION THAT A PATIENT WITH A 29MM 11500A AORTIC VALVE, IMPLANTED IN THE PULMONARY POSITION, UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 6 YEARS, 4 MONTHS DUE TO MODERATE REGURGITATION AND STENOSIS. THE PATIENT PRESENTED WITH SOB. THE PROCEDURE WAS PERFORMED WITH A 29MM 9755RSL TRANSCATHETER VALVE. THE PATIENT WAS IN STABLE CONDITION POST PROCEDURE AND DISCHARGED POD #1.

  Patient problems: Dyspnea

  MAUDE report 23707977 ↗
• InjuryDec 3, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 29MM 11500A AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 6 YEARS, 7 MONTHS DUE TO STENOSIS AND REGURGITATION. THE PROCEDURE WAS PERFORMED WITH A 29MM 9755RSL TRANSCATHETER VALVE.

  Patient problems: Insufficient Information

  MAUDE report 23707868 ↗
• InjuryDec 3, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 29MM 11500A AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 2 YEARS, 3 MONTHS DUE TO UNKNOWN REASON. THE EXPLANTED DEVICE WAS REPLACED WITH A 25MM 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: Insufficient Information

  MAUDE report 23706230 ↗
• InjuryNov 30, 2025Device Dislodged or Dislocated; Insufficient Device Problem Information; Device Dislodged or Dislocated; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND MEDICAL RECORD THAT A 29MM 11500A RESILIA AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF (B)(6) DUE TO DEHISCENCE WITH SEVERE PVL. PATIENT PRESENTED WITH WORSENING DYSPNEA. AVR WAS COMPLETED WITH A 29MM 11060A KONECT VALVED CONDUIT. PER MEDICAL RECORD, PATIENT PRESENTED WITH PARTIAL VALVE DEHISCENCE AND WAS FOUND TO HAVE HEALED ENDOCARDITIS. ECHO DEMONSTRATED ROCKING MOTION OF AORTIC VALVE WITH SEVERE PVL. PATIENT UNDERWENT URGENT REDO AVR VIA BIOBENTALL PROCEDURE. POST-PROCEDURE ECHO DEMONSTRATED NO REGURGITATION.

  Patient problems: Dyspnea; Insufficient Information

  MAUDE report 23677424 ↗
• InjuryNov 13, 2025Degraded; Insufficient Device Problem Information; Degraded; Insufficient Device Problem Information

  IT WAS REPORTED AND THROUGH RECEIPT OF MEDICAL RECORDS, A PATIENT WITH A 29MM 11500A AORTIC VALVE IMPLANTED THREE (3) YEARS, 10 MONTHS, UNDERWENT VALVE-IN-VALVE PROCEDURE DUE TO SEVERE STENOSIS AND DEGENERATION. PATIENT PRESENTED WITH DYSPNEA ON EXERTION AND CONGESTIVE HEART FAILURE. TAVR WAS SUCCESSFULLY PERFORMED WITH A 26MM SAPIEN3ULTRA TRANSCATHETER VALVE WITHOUT COMPLICATIONS. PATIENT DID WELL IN RECOVERY AND WAS TRANSFERRED TO CSSU ON POD# 0. PATIENT WAS DISCHARGED HOME ON POD #1.

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

  MAUDE report 23547215 ↗
• InjuryOct 16, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A 29MM 11500A AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 9 MONTHS DUE TO ENDOCARDITIS WITH SEVERE INSUFFICIENCY. THE PATIENT PRESENTED WITH ACUTE CVA. THE EXPLANTED DEVICE WAS REPLACED WITH A 25MM 11500A AORTIC VALVE. PER MEDICAL RECORDS, THE PATIENT PRESENTED TO THE HOSPITAL WITH STROKE-LIKE SYMPTOMS AND WAS FOUND TO HAVE ACUTE CVA. THE PATIENT UNDERWENT A REDO-AVR, REPAIR OF AN AORTIC ROOT ABSCESS WITH PERICARDIAL PATCH REPAIRS. POST-OPERATIVE TEE SHOWED WELL SEATED AORTIC VALVE WITH NO FINDINGS OF PVL. THE PATIENT WAS TRANSFERRED TO THE ICU IN STABLE CONDITION AND DISCHARGE ON POD #4.

  Patient problems: Insufficient Information

  MAUDE report 23312898 ↗
• InjuryOct 15, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED VIA THE PATIENT REGISTRY THAT A PATIENT WITH A 29MM 11500A INSPIRIS VALVE UNDERWENT REDO AORTIC VALVE REPLACEMENT AFTER AN IMPLANT DURATION OF THREE (3) YEARS, 11 MONTHS DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH A 29MM 11060A AORTIC 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: Insufficient Information

  MAUDE report 23302203 ↗
• InjurySep 19, 2025Calcified; Patient Device Interaction Problem; Calcified; Patient Device Interaction Problem

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A PATIENT WITH A 29MM 11500A AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 5 YEARS, 6 MONTHS DUE TO AORTIC ROOT ANEURYSM. THE EXPLANTED VALVE WAS REPLACED WITH A 27MM 11060A VALVED CONDUIT. THE PATIENT WAS DISCHARGED ON POD #8. PER HOSPITAL PATHOLOGY REPORT: AORTIC PROSTHETIC VALVE, CUSPS HAVE IRREGULAR, TAN-YELLOW TO TAN-BROWN DEPOSITS RANGING FROM .1CM TO 1.8CM DIMENSION. NO CALCIFICATION IS SEEN GROSSLY. PATHOLOGY DX: VALVE WITH CALCIFIC DEGENERATIVE CHANGES. CLINICAL DX: AORTIC STENOSIS. 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 INFOR

  Patient problems: Insufficient Information

  MAUDE report 23101619 ↗
• InjurySep 17, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 29MM 11500A AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 2 YEARS AND 7 MONTHS DUE TO UNKNOWN REASON. THE VALVE WAS REPLACED WITH A 27MM 11500A AORTIC VALVE.

  Patient problems: Insufficient Information

  MAUDE report 23070189 ↗
• InjurySep 4, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 29MM 11500A RESILIA AORTIC VALVE IN AORTIC POSITION WAS EXPLANTED AND REPLACED WITH A 25MM 11060A KONECT VALVED CONDUIT AFTER AN IMPLANT DURATION OF 2 YEARS, 10 MONTHS. REASON FOR REINTERVENTION WAS NOT PROVIDED. 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 22965887 ↗
• InjuryAug 18, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED VIA THE PATIENT REGISTRY THAT A PATIENT WITH A 29MM 11500A INSPIRIS VALVE UNDERWENT REDO AORTIC VALVE REPLACEMENT AFTER AN IMPLANT DURATION OF THREE (3) 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 22829898 ↗
• InjuryAug 12, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 29MM 11500A RESILIA AORTIC VALVE IN AORTIC POSITION WAS EXPLANTED AND REPLACED WITH A 29MM 11060A KONECT VALVED CONDUIT AFTER AN IMPLANT DURATION OF 2 YEARS, 5 MONTHS. REASON FOR REINTERVENTION WAS NOT PROVIDED. 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 22782587 ↗
• InjuryAug 12, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 29MM 11500A RESILIA AORTIC VALVE WAS EXPLANTED AND REPLACED WITH A 27MM 11500A RESILIA AORTIC VALVE AFTER AN IMPLANT DURATION OF 6 YEARS, 1 MONTH 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 22782429 ↗