EDWARDS INTUITY ELITE AORTIC VALVE 8300AB (REF 8300AB21A)Recalls & reported problems

Summary

The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 00690103194487), received between Mar 1, 2021 and Aug 3, 2026 — classified as 1 death, 52 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (24 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 53 reports, in the reporter's own words as published by the FDA.

• InjuryAug 3, 2026Calcified

  It was learned through Implant Patient Registry and investigation that a patient with a 21mm 8300AB aortic valve was explanted after an implant duration of 8 years, due to calcification and stenosis. The explanted valve was replaced with a 23mm 11500A valve. Per medical records, the patient presented with heart failure NYHA class III and underwent a redo AVR. Intraop, the prior 21mm valve was removed, the annulus was sized and a 23mm 11500A valve was implanted with pledgeted sutures and secured with Cor-Knots. Post TEE showed no evidence of malfunction or leak. The patient was transferred to ICU in stable condition.Hospital pathology report: gross exam shows that the valve has 3 yellow calcified leaflets.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 source

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 50123920 ↗
• InjuryJul 27, 2026Patient Device Interaction Problem

  It was learned through receipt of medical records, that a patient with a 21mm 8300AB aortic valve implanted had complete heart block requiring permanent pacemaker on POD#2.Per medical records, the patient underwent TAVR explant with placement of a 21mm Edwards Intuity surgical valve. Post-operative course was complicated by CHB s/p PPM on POD#2. The patient was discharged home with HH on POD#5.

  Patient problems: Heart Block

  MAUDE report 50015504 ↗
• InjuryNov 24, 2025Intravalvular regurgitation; Intravalvular regurgitation

  IT WAS REPORTED THAT A 21MM 8300AB INTUITY AORTIC VALVE IN AORTIC POSITION WAS DISABLED VIA VALVE IN VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 5 YEARS, 6 MONTHS DUE TO SEVERE AORTIC INSUFFICIENCY WITH PANNUS OBSERVED ON THE VALVE. THE PATIENT PRESENTED IN CHF/SHOCK. THE PROCEDURE WAS PERFORMED WITH A 20MM 9750TFX AND PATIENT WAS STABLE THROUGHOUT THE PROCEDURE. IT WAS LEARNED THROUGH PATIENT SUPPORT CENTER THAT THE PATIENT LATER EXPIRED.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 23638970 ↗
• InjuryNov 10, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY A 21MM 8300AB IMPLANTED IN THE AORTIC POSITION WAS EXPLANTED AFTER AN IMPLANT DURATION OF 8 YEARS AND 7 MONTHS DUE TO UNKNOWN REASON. THE VALVE WAS REPLACED WITH A 23MM 11500A BIOPROSTHETIC VALVE.

  Patient problems: Insufficient Information

  MAUDE report 23515363 ↗
• InjurySep 9, 2025Intravalvular regurgitation; Intravalvular regurgitation

  IT WAS REPORTED THAT A PATIENT WITH A 21MM 8300AB AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 6 YEARS, 5 MONTHS DUE TO SEVERE REGURGITATION AND MODERATE STENOSIS. THE TAVR WAS SUCCESSFULLY PERFORMED WITH A 20MM 9755RSL VALVE. THE PATIENT WAS STABLE POST-PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 23008540 ↗
• InjurySep 9, 2025Perivalvular Leak; Intravalvular regurgitation; Perivalvular Leak; Intravalvular regurgitation

  IT WAS REPORTED THAT A PATIENT WITH A 21MM 8300AB AORTIC VALVE HAS BEEN PLACED UNDER CONSIDERATION FOR A VALVE-IN-VALVE (SAVR) PROCEDURE AFTER AN IMPLANT DURATION OF 89 DAYS DUE TO PVL.

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

  MAUDE report 23000237 ↗
• InjuryAug 19, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 21MM 8300AB INTUITY VALVE UNDERWENT REDO AORTIC VALVE REPLACEMENT AFTER AN IMPLANT DURATION OF FOUR (4) YEARS, SIX (6) MONTHS DUE TO AORTIC STENOSIS. THE EXPLANTED VALVE WAS REPLACED WITH A 23MM 11500A INSPIRIS VALVE.

  Patient problems: Insufficient Information

  MAUDE report 22841584 ↗
• InjuryAug 13, 2025Perivalvular Leak; Perivalvular Leak

  IT WAS REPORTED THAT A PATIENT WITH A 21MM 8300AB AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 7 YEARS, 8 MONTHS DUE TO PVL. THE PATIENT PRESENTED WITH SYMPTOMATIC SYMPTOMS OF CONGESTIVE HEART FAILURE, AND SHORTNESS OF BREATH. THE TAVR WAS SUCCESSFULLY PERFORMED WITH A 23MM 9755RSL VALVE.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 22794741 ↗
• InjuryJul 17, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED AND LEARNED FROM MEDICAL RECORDS THAT A PATIENT WITH A 21MM 8300AB AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 3 YEARS, 3 MONTHS DUE TO MODERATE AORTIC STENOSIS WITH PEAK GRADIENT OF 51MMHG, MEAN GRADIENT OF 34MMHG, AVA 0.67CM2 AND EF OF 40-45%. THE PATIENT PRESENTED WITH CHEST PAIN AND DYSPNEA. THE TAVR WAS SUCCESSFULLY PERFORMED WITH A 23MM 9755RSL VALVE WITHOUT COMPLICATIONS. THE PATIENT WAS DISCHARGED ON POD#1.

  Patient problems: Dyspnea

  MAUDE report 22532617 ↗
• InjuryJul 14, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED AND LEARNED THROUGH INVESTIGATION AND MEDICAL RECORDS, THAT A PATIENT WITH A 21MM 8300AB AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 7 YEARS, 2 MONTHS DUE TO SEVERE AORTIC STENOSIS, THICKENED VALVE LEAFLETS WITH RESTRICTED MOTION. THE PATIENT PRESENTED WITH SYMPTOMS OF HEART FAILURE. THE TMVR WAS PERFORMED SUCCESSFULLY WITH NON-EDWARDS DEVICE WITH NO COMPLICATIONS. THE PATIENT WAS SENT TO PACU POST PROCEDURE IN STABLE CONDITION AND WAS DISCHARGED ON POD#1. PER MEDICAL RECORDS, TEE DEMONSTRATED SEVERE BIOPROSTHETIC AORTIC STENOSIS WITH THICKENED LEAFLET AND RESTRICTED MOTION (MEAN GRADIENT 34 MMHG).

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 22494973 ↗
• InjuryJul 8, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED AND LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 21MM 8300AB AORTIC VALVE IN AORTIC POSITION UNDERWENT A VALVE EXCHANGE AFTER AN IMPLANT DURATION OF 5 YEARS, AND 11 MONTHS. AVR WAS COMPLETED WITH A 21MM 11500A RESILIA AORTIC VALVE.

  Patient problems: Insufficient Information

  MAUDE report 22436586 ↗
• InjuryJun 27, 2025Calcified; Insufficient Device Problem Information; Calcified; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 21MM 8300AB AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 6 YEARS, 11 MONTHS DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH A 23MM 11500A INSPIRIS RESILIA 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

  MAUDE report 22343243 ↗
• InjuryJun 12, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 21 MM 8300AB INTUITY VALVE HAS UNDERWENT A VALVE IN VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 8 YEARS, 7 MONTHS DUE TO SEVERE STENOSIS. THE PATIENT PRESENTED WITH HEART FAILURE. THE TAVR WAS PERFORMED WITH A 23 MM 9750TFX TRANSCATHETER VALVE. THE PATIENT WAS STABLE POST PROCEDURE AND DISCHARGED ON POD #1.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 22194554 ↗
• InjuryApr 30, 2025Device Stenosis; Device Stenosis

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A PATIENT WITH A 21MM 8300AB AORTIC VALVE, WAS EXPLANTED AFTER AN IMPLANT DURATION OF 7 YEARS, 2 MONTHS DUE TO STENOSIS. THE PATIENT PRESENTED WITH SYMPTOMS OF HEART FAILURE. THE EXPLANTED VALVE WAS REPLACED WITH A 23MM 11500A AORTIC VALVE. THE PATIENT WAS STABLE POST-PROCEDURE IN THE ICU AND WAS DISCHARGED ON POD #7. 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 21936632 ↗
• InjuryApr 4, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A PATIENT WITH A 21MM 8300AB AORTIC VALVE SYSTEM UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 7 YEARS AND TEN (10) MONTHS DAYS DUE TO UNKNOWN REASON. THE PROCEDURE WAS PERFORMED WITH A 23MM 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: Insufficient Information

  MAUDE report 21778512 ↗
• InjuryApr 1, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH RECEIPT OF DEVICE IN THE EDWARDS DECONTAMINATION LAB THAT A 21MM 8300AB AORTIC VALVE WAS EXPLANTED AFTER UNKNOWN IMPLANT DURATION DUE TO UNKNOWN REASONS. THE 21MM 8300AB AORTIC VALVE WAS IMPLANTED (B)(6) 2024.

  Patient problems: Insufficient Information

  MAUDE report 21748614 ↗
• InjuryMar 18, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 21MM 8300AB AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 6 YEARS, 5 MONTHS DUE TO REGURGITATION. THE PATIENT PRESENTED WITH SOB. THE PROCEDURE WAS PERFORMED WITH A 23MM 9600TFX TRANSCATHETER VALVE. THE PATIENT WAS IN STABLE CONDITION POST PROCEDURE AND DISCHARGED POD #2.

  Patient problems: Dyspnea

  MAUDE report 21634974 ↗
• InjuryJan 28, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED VIA THE PATIENT REGISTRY THAT A PATIENT WITH A 21MM 8300AB INTUITY VALVE IN THE AORTIC POSITION UNDERWENT REDO AORTIC VALVE REPLACEMENT AFTER AN IMPLANT DURATION OF SEVEN (7) YEARS, ONE (1) MONTH DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH A 23MM 11060A KONECT 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 21259638 ↗
• InjuryJan 9, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 8300AB 21MM AORTIC VALVE IS BEING EVALUATED FOR A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 6 YEARS, 5 MONTHS DUE TO STENOSIS. THE PATIENT PRESENTED WITH HF.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 21113183 ↗
• InjuryJan 6, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS LEARNED THROUGH RECEIPT OF MEDICAL RECORDS, THAT PATIENT WITH A 21MM 8300AB AORTIC VALVE IMPLANTED HAD HEART BLOCK REQUIRING PPM ON POD #1.

  Patient problems: Heart Block

  MAUDE report 21086159 ↗
• InjuryDec 5, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT WITH A 21MM 8300AB AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 7 YEARS, 1 MONTHS DUE TO UNKNOWN REASONS. THE PROCEDURE WAS PERFORMED WITH A 20MM 9755RSL TRANSCATHETER VALVE. THE PATIENT WAS TAKEN TO RECOVERY POST PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 20856851 ↗
• InjuryNov 15, 2024Calcified; Calcified

  IT WAS REPORTED A PATIENT WITH A 21MM 8300AB AORTIC VALVE IMPLANTED THREE (3) YEARS, EIGHT (8) MONTHS, IS BEING EVALUATED FOR VALVE-IN-VALVE PROCEDURE DUE TO LEAFLET CALCIFICATION.

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

  MAUDE report 20696543 ↗
• InjuryOct 15, 2024Fluid/Blood Leak; Insufficient Device Problem Information; Device Stenosis; Fluid/Blood Leak; Insufficient Device Problem Information; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 21MM 8300AB INTUITY VALVE UNDERWENT VALVE-IN-VALVE INTERVENTION AFTER AN IMPLANT DURATION OF SIX (6) YEARS, THREE (3) MONTHS DUE TO AORTIC STENOSIS AND REGURGITATION. THE TAVR PROCEDURE WAS PERFORMED WITH A 23MM NON-EDWARDS TRANSCATHETER VALVE. THE PATIENT LEFT THE PROCEDURE IN STABLE CONDITION.

  Patient problems: Insufficient Information

  MAUDE report 20453018 ↗
• DeathSep 13, 2024Degraded; Degraded

  IT WAS REPORTED AND LATER LEARNED THAT A PATIENT WITH A 21MM 8300AB AORTIC VALVE HAS BEEN PLACED UNDER CONSIDERATION FOR A VALVE-IN-VALVE AFTER AN IMPLANT DURATION OF 6 YEARS, 9 MONTHS DUE TO DEGENERATION. THE PATIENT PRESENTED WITH CHRONIC HEART FAILURE. THE RE-INTERVENTION PROCEDURE DID NOT OCCUR AS THE PATIENT EXPIRED DUE TO SEVERE LIVER FAILURE.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 20217539 ↗
• InjurySep 9, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THROUGH IMPLANT PATIENT REGISTRY IT WAS LEARNED A PATIENT WITH A 21MM 8300AB AORTIC VALVE IMPLANTED SIX (6) YEARS, SEVEN (7) MONTHS, UNDERWENT VALVE-IN-VALVE PROCEDURE DUE TO UNKNOWN REASONS. TAVR WAS PERFORMED WITH A 23MM 9750TFX 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: Insufficient Information

  MAUDE report 20176932 ↗