EDWARDS INTUITY ELITE AORTIC VALVE 8300AB (REF 8300AB27A)Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00690103194517), received between Mar 9, 2021 and Aug 20, 2025 — classified as 16 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (10 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryAug 20, 2025Calcified; Insufficient Device Problem Information; Calcified; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 27MM 8300AB AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 8 YEARS, 1 MONTHS DUE TO UNKNOWN REASON. 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: Dyspnea; Insufficient Information

  MAUDE report 22852291 ↗
• InjuryAug 1, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED A PATIENT WITH A 27MM 8300AB AORTIC VALVE IMPLANTED SIX (6) YEARS, UNDERWENT VALVE-IN-VALVE PROCEDURE DUE TO SEVERE AORTIC STENOSIS. TAVR WAS SUCCESSFULLY PERFORMED WITH A 23MM S3UR TRANSCATHETER VALVE. PATIENT WAS STABLE AT THE END OF THE PROCEDURE.

  Patient problems: Dyspnea; Insufficient Information

  MAUDE report 22688862 ↗
• InjuryJul 28, 2025Calcified; Insufficient Device Problem Information; Calcified; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 27MM 8300AB AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 7 YEARS, 11 MONTHS DUE TO UNKNOWN REASONS. THE PROCEDURE WAS PERFORMED WITH A 26MM 9755RSL TRANSCATHETER 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

  MAUDE report 22636073 ↗
• InjuryMar 27, 2025Perivalvular Leak; Device Stenosis; Perivalvular Leak; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 27MM 8300AB INTUITY AORTIC VALVE SYSTEM UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF FOUR (4) YEARS AND FIVE (5) MONTHS DAYS DUE TO MILD-MODERATE STENOSIS, MODERATE-SEVERE PARAVALVULAR LEAK. THE PATIENT WAS PRESENTED WITH HEART FAILURE. THE PROCEDURE WAS PERFORMED WITH A 26MM 9755RSL TRANSCATHETER VALVE WITH PVL CLOSURE USING 8MM AMPLATZER.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 21709446 ↗
• InjurySep 13, 2024Calcified; Insufficient Device Problem Information; Calcified; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND PATHOLOGY REPORT THAT A 27MM 8300AB AORTIC VALVE IN AORTIC POSITION WAS EXPLANTED AND REPLACED WITH A 27MM 11500A AORTIC VALVE AFTER AN IMPLANT DURATION OF 6 YEARS, 8 MONTHS DUE TO DEGENERATION AND CALCIFICATION. THE PATIENT WAS IN RECOVERY POST-OPERATIVE. PER PATHOLOGY, GROSS EXAMINATION SHOWED LEAFLETS TO BE CALCIFIED AND STIFF. ONE LEAFLET SHOWED A 0.5CM PENETRATING DEFECT NEAR THE SUTURE RING. NO VEGETATIONS. MICROSCOPIC EXAMINATION SHOWED VALVE TISSUE THICKENING, FIBRINOID DEGENERATION, AND CALCIFICATION.

  Patient problems: Insufficient Information

  MAUDE report 20218106 ↗
• InjuryJul 10, 2024Insufficient Device Problem Information; Device Stenosis; Insufficient Device Problem Information; Device Stenosis

  THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION, IT WAS LEARNED A 27MM 8300AB AORTIC VALVE IMPLANTED SEVEN (7) YEARS, SIX (6) MONTHS, WAS EXPLANTED DUE TO STENOSIS. PATIENT PRESENTED WITH SHORTNESS OF BREATH. THE EXPLANTED DEVICE WAS REPLACED WITH A 27MM 11500A AORTIC VALVE. PATIENT WAS STABLE AT THE END OF THE OPERATION.

  Patient problems: Dyspnea; Insufficient Information

  MAUDE report 19713009 ↗
• InjuryJun 21, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THROUGH IMPLANT PATIENT REGISTRY IT WAS LEARNED THAT A 27MM 8300AB VALVE IN THE AORTIC POSITION WAS EXPLANTED AFTER AN IMPLANT DURATION OF 1 YEAR, 3 MONTHS DUE TO UNKNOWN REASON. THE EXPLANTED VALVE WAS REPLACED WITH A 29MM 11500A VALVE.

  Patient problems: Insufficient Information

  MAUDE report 19586382 ↗
• InjuryMay 17, 2024Microbial Contamination of Device; Insufficient Device Problem Information; Microbial Contamination of Device; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 27MM 8300A AORTIC VALVE IN AORTIC POSITION WAS EXPLANTED AFTER AN IMPLANT DURATION OF FIVE (5) YEARS, 11 MONTHS DUE TO UNKNOWN CAUSE. AVR WAS COMPLETED WITH A 29MM 11500A INSPIRIS RESILIA AORTIC VALVE. THE PATIENT WAS IN RECOVERY POST OPERATIVE. 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 19347234 ↗
• InjuryMay 7, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 8300AB 27MM VALVE, IN AORTIC POSITION, WAS EXPLANTED AFTER AND IMPLANT DURATION OF 11 DAYS DUE TO UNKNOWN REASON. THE VALVE WAS REPLACED WITH A 11500A 27MM VALVE.

  Patient problems: Insufficient Information

  MAUDE report 19262143 ↗
• InjuryApr 30, 2024Degraded; Gradient Increase; Degraded; Gradient Increase

  IT WAS REPORTED THAT PATIENT WITH A 27MM 8300AB AORTIC VALVE, HAS BEEN PLACED UNDER EVALUATION FOR A RE-INTERVENTION AFTER IMPLANT DURATION OF FIVE (5) YEARS, EIGHT (8) MONTHS DUE TO DEGENERATION AND STENOSIS. THE PATIENT PRESENTED WITH HEART FAILURE, CHEST PAIN WITH EXERTION, AND ORTHOPNEA. THE PROCEDURE NOT SCHEDULED YET.

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

  MAUDE report 19217208 ↗
• InjuryJul 21, 2023Degraded; Insufficient Device Problem Information; Degraded; Insufficient Device Problem Information

  IT WAS REPORTED, THAT A PATIENT WITH A 27MM 8300AB VALVE. UNDERWENT A VALVE-IN-VALVE PROCEDURE, AFTER AN IMPLANT DURATION OF SIX (6) YEARS, TWO (2) MONTHS, DUE TO UNKNOWN REASONS. THE TAVR WAS PERFORMED WITH A 26MM, 9755RSL TRANSCATHETER VALVE. PATIENT WAS IN RECOVERY POST PROCEDURE.

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

  MAUDE report 17374534 ↗
• InjuryOct 13, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  THROUGH IMPLANT PATIENT REGISTRY IT WAS LEARNED THAT A 27MM 8300AB VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 3 YEARS, 17 DAYS DUE TO UNKNOWN REASON. THE EXPLANTED VALVE WAS REPLACED WITH A 29MM 3300TFX VALVE. THE PATIENT WAS IN RECOVERY POST PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 15596729 ↗
• InjuryDec 14, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THROUGH THE IMPLANT PATIENT REGISTRY, IS WAS LEARNED THAT A PATIENT WITH A 27MM 8300AB AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF THREE YEARS, NINE MONTHS DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH A 29MM 11060A VALVE. THE PATIENT NOTED TO BE IN RECOVERY. NO OTHER DETAILS WERE 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 13003579 ↗
• InjuryDec 6, 2021Perivalvular Leak; Perivalvular Leak

  IT WAS REPORTED THAT A PATIENT WITH A 27MM AORTIC VALVE IS BEING EVALUATED FOR A BALLOON AORTIC VALVULOPLASTY PROCEDURE AFTER AN IMPLANT DURATION OF 4 YEARS DUE TO MODERATE PERIVALVULAR LEAK. THE PATIENT PRESENTED WITH NYHA CLASS II.

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

  MAUDE report 12934605 ↗
• InjuryMar 19, 2021Perivalvular Leak; Perivalvular Leak

  THROUGH REVIEW OF MEDICAL RECORDS, EDWARDS LEARNED THAT A PATIENT WITH A 27MM 8300AB AORTIC VALVE UNDERWENT PVL CLOSURE AFTER AN IMPLANT DURATION OF APPROXIMATELY FOUR (4) MONTHS DUE TO PERIVALVULAR LEAK (PVL). POST-PROCEDURE THE PATIENT'S CLINICAL CONDITION IMPROVED.

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

  MAUDE report 11529921 ↗
• InjuryMar 9, 2021Perivalvular Leak; Perivalvular Leak

  THROUGH IMPLANT PATIENT REGISTRY, IT WAS REPORTED THAT A 27MM 8300AB AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF ONE (1) YEAR, THREE (3) MONTHS DUE TO MODERATE-SEVERE PERIVALVULAR LEAK (PVL). THE EXPLANTED VALVE WAS REPLACED WITH A 29MM 3300TFX AORTIC VALVE. THE IMPLANTATION DATA CARD INDICATED THAT THE DEVICE EXPLANT WAS NOT DUE TO DEFICIENCY OF THE ORIGINAL DEVICE. PER MEDICAL RECORDS, THE PERIVALVULAR LEAK WAS IDENTIFIED BETWEEN THE RIGHT AND NONCORONARY CUSP. THE 27MM VALVE AND AMPLATZER SEPTAL OCCLUDERS X2 WERE EXPLANTED AND REPLACED WITH A 29MM 3300TFX AORTIC VALVE. A MV REPAIR WITH A NON-EDWARDS ANNULOPLASTY RING WAS ALSO PERFORMED. POSTOPERATIVE TEE REVEALED EXCELLENT VALVE FUNCTION WITH NO SIGNIFICANT PVL. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TRANSFERRED TO THE ICU IN STABLE CONDITION. 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 STA

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 11447232 ↗