EDWARDS INTUITY ELITE AORTIC VALVE 8300AB (REF 8300AB23A)Recalls & reported problems

Summary

The FDA's MAUDE database contains 60 adverse event reports that list this exact device (DI 00690103194494), received between Apr 7, 2021 and May 16, 2026 — classified as 60 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (27 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 60 reports, in the reporter's own words as published by the FDA.

• InjuryMay 16, 2026Degraded

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATED THAT A PATIENT WITH A 23MM 8300AB AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 7 YEARS, 5 MONTHS DUE TO DEGENERATION AND STENOSIS. PATIENT PRESENTED WITH SHORTNESS OF BREATH, CHEST PAIN AND LIGHTHEADEDNESS. THE EXPLANTED VALVE WAS REPLACED WITH A 25MM 11500A VALVE. PATIENT WAS TRANSFERRED TO ICU AND DISCHARGED ON POD#3. 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

  MAUDE report 25195102 ↗
• InjuryMar 30, 2026Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 23MM 8300AB AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 7 YEARS, 11 MONTHS DUE TO UNKNOWN REASON. THE EXPLANTED VALVE WAS REPLACED WITH A 23MM 3300TFX VALVE. THE PATIENT EXPIRED 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 24736846 ↗
• InjuryMar 20, 2026Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 8300AB 23MM AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 6 YEARS AND 4 MONTHS DUE TO UNKNOWN REASON. THE VALVE WAS REPLACED WITH A 11500A 25MM VALVE.

  Patient problems: Insufficient Information

  MAUDE report 24653753 ↗
• InjuryOct 20, 2025Intravalvular regurgitation; Intravalvular regurgitation

  IT WAS REPORTED THAT A PATIENT WITH A 23MM 8300AB AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 7 YEARS, 9 MONTHS DUE TO REGURGITATION. PATIENT PRESENTED WITH HEART FAILURE AND SHORTNESS OF BREATH. THE PROCEDURE WAS PERFORMED WITH A 23MM 9755RSL TRANSCATHETER VALVE. PATIENT WAS STABLE POST PROCEDURE. THIS IS A 4-YEAR-OLD MALE PATIENT.

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

  MAUDE report 23334127 ↗
• InjuryOct 15, 2025Degraded; Degraded

  IT WAS REPORTED AND LEARNED THROUGH THE INVESTIGATION AND THE INVESTIGATION THAT A PATIENT WITH A 23MM 8300AB AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF APPROXIMATELY 7 YEARS, 4 MONTHS DUE TO DEGENERATION AND STENOSIS. THE PATIENT PRESENTED WITH SYMPTOMS OF HEART FAILURE-SHORTNESS OF BREATH. THE PROCEDURE WAS PERFORMED WITH A 23MM 9755RSL TRANSCATHETER VALVE. THE PATIENT WAS IN STABLE CONDITION POST-PROCEDURE AND WAS DISCHARGED ON POD # 1.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 23284998 ↗
• InjurySep 17, 2025Device Stenosis; Device Stenosis

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A PATIENT WITH A 23MM 8300AB AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 6 YEARS, 9 MONTHS DUE TO REGURGITATION AND STENOSIS. THE PATIENT PRESENTED WITH SOB. THE EXPLANTED VALVE WAS REPLACED WITH A 23MM 3300TFX VALVE. THE PATIENT WAS TAKEN TO THE ICU IN STABLE CONDITION POST PROCEDURE. THE PATIENT WAS DISCHARGED POD #5. 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

  MAUDE report 23075179 ↗
• InjurySep 12, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 23MM 8300AB AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 7 YEARS, 6 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 23042116 ↗
• InjuryAug 18, 2025Device Stenosis; Intravalvular regurgitation; Device Stenosis; Intravalvular regurgitation

  IT WAS REPORTED THAT A PATIENT WITH A 31MM VALVE UNDERWENT A VALVE-IN-VALE PROCEDURE AFTER AN UNKNOWN IMPLANT DURATION DUE TO STENOSIS AND REGURGITATION. THE PROCEDURE WAS PERFORMED WITH A 29MM 9600TFX TRANSCATHETER VALVE. THE PATIENT WAS IN STABLE CONDITION POST PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 22835272 ↗
• InjuryAug 4, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 23MM 8300AB AORTIC VALVE IS UNDER CONSIDERATION FOR A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 6 YEARS, 8 MONTHS DUE TO STENOSIS AND REGURGITATION. PATIENT PRESENTED WITH SHORTNESS OF BREATH AND LOWER EXTREMITY EDEMA.

  Patient problems: Dyspnea

  MAUDE report 22710460 ↗
• InjuryAug 1, 2025Perivalvular Leak; Perivalvular Leak

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A PATIENT WITH A 23MM 8300AB AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 3 YEARS, 10 MONTHS DUE TO A MODERATE-SEVERE PERIVALVULAR LEAK. THE EXPLANTED VALVE WAS REPLACED WITH A 27MM 11500A VALVE. PER MEDICAL RECORDS, THE PATIENT PRESENTED WITH CONGESTIVE HEART FAILURE. PRE-OP TEE SHOWED PVL ORIGINATED CLOSE TO SEPTUM AND RCC. BAV WAS ATTEMPTED TO ENHANCE THE CUFF OF THE INTUITY VALVE, HOWEVER THE GAP WAS FOUND TO BE RATHER LARGE SO IC DECIDED NOT TO CONTINUE AS THE PATIENT WILL NEED AVR. THE PATIENT UNDERWENT REDO MIS AVR, RUL WEDGE RESECTION, CRYOABLATION AND LAA CLOSURE/EPICARDIAL CLIP. INTRAOPERATIVE FINDINGS SHOWED MAIN LEAK BETWEEN THE AREA OF THE COMMISSURE WITH RCC AND NCC, THIS DISRUPTION EXTENDED ALL THE WAY TO THE SUTURE THAT WAS IN THE NADIR OF THE NCC. THE VALVE WAS REMOVED WITH ALL 3 SUTURES AND COR-KNOTS. A 27MM 11500A WAS IMPLANTED WITH HORIZONTAL MATTRESS SUTURES AND SECURED WITH COR-KNOTS. THERE WAS GOOD COAPTATION OF THE VALVE TO THE ANNULUS. THE PATIENT WAS TRANSFERRED TO THE ICU IN CRITICAL, BUT STABLE CONDITION AND DISCHARGED ON POD #6. EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PA

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 22693151 ↗
• InjuryJun 26, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A PATIENT WITH A 23MM 8300AB INTUITY VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF SEVEN (7) YEARS AND 10 MONTHS DUE TO UNKNOWN REASON. THE PROCEDURE 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 22342592 ↗
• InjuryJun 21, 2025Intravalvular regurgitation; Intravalvular regurgitation

  IT WAS REPORTED THAT A PATIENT WITH A 23MM 8300AB INTUITY VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF THREE (3) YEARS AND SIX (6) DAYS DUE REGURGITATION. THE PROCEDURE WAS PERFORMED WITH 26MM 9755RSL TRANSCATHETER VALVE.

  Patient problems: Insufficient Information

  MAUDE report 22303946 ↗
• InjuryJun 10, 2025Degraded; Degraded

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND MEDICAL RECORDS THAT A PATIENT WITH A 23MM 8300AB AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 7 YEARS, 5 MONTHS DUE TO STRUCTURAL VALVE DEGENERATION, SEVERE STENOSIS, AND MODERATE REGURGITATION. THE PATIENT PRESENTED WITH NYHA III HEART FAILURE, SOB, AND FATIGUE. THE PROCEDURE WAS PERFORMED WITH A 23MM 9755RSL TRANSCATHETER VALVE. THE PATIENT WAS TAKEN TO THE CVU POST PROCEDURE AND DISCHARGED POD #2. PER MEDICAL RECORDS, THE PATIENT PRESENTED WITH NYHA III HEART FAILURE, SOB, AND FATIGUE. PRE-OP TTE ((B)(6) 2024) REVEALED LVEF 30-35% WITH MOD AORTIC STENOSIS AND MOD MITRAL REGURGITATION. TAVR PROCEDURE WAS PERFORMED TO REPLACE THE 23MM 8300AB WITH A 23MM 9755RSL. THE PROCEDURE WAS SUCCESSFUL WITH NO COMPLICATIONS. THE PATIENT WAS TAKEN TO THE CVU POST PROCEDURE AND DISCHARGED POD #2. 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 A

  Patient problems: Dyspnea; Heart Failure/Congestive Heart Failure

  MAUDE report 22178581 ↗
• InjuryJun 10, 2025Inadequacy of Device Shape and/or Size; Insufficient Device Problem Information; Thickening of Material; Inadequacy of Device Shape and/or Size; Insufficient Device Problem Information; Thickening of Material

  IT WAS REPORTED A PATIENT WITH A 23MM 8300AB AORTIC VALVE IMPLANTED FOUR (4) YEARS, TWO (2) MONTHS, UNDERWENT VALVE-IN-VALVE PROCEDURE DUE TO UNKNOWN REASONS. TAVR WAS PERFORMED WITH A NON-EDWARDS TRANSCATHETER VALVE. TWO (2) WEEKS POST TAVR THE PATIENT REQUIRED TMVR AND THE TEAM FELT THAT THE 8300AB POSSIBLY LED TO THE FAILURE OF THE NON-EDWARDS SURGICAL VALVE IN THE MITRAL POSITION.

  Patient problems: Dyspnea; Insufficient Information

  MAUDE report 22177559 ↗
• InjuryJun 10, 2025Calcified; Calcified

  IT WAS REPORTED THAT A PATIENT WITH A 23MM 8300AB AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 7 YEARS, 3 MONTHS DUE TO CALCIFICATION, SEVERE STENOSIS, AND MILD REGURGITATION. THE PATIENT PRESENTED WITH HEART FAILURE. THE TAVR WAS SUCCESSFULLY PERFORMED WITH A 23MM 9755RSL VALVE. THE PATIENT WAS IN STABLE CONDITION POST PROCEDURE AND DISCHARGED ON THE SAME DAY.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 22177077 ↗
• InjuryMay 15, 2025Calcified; Calcified

  IT WAS REPORTED THAT A PATIENT WITH A 23MM 8300AB AORTIC VALVE, UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER IMPLANT DURATION OF 7 YEARS DUE TO CALCIFICATION. THE PATIENT PRESENTED WITH FATIGUE. THE TAVR PROCEDURE WAS SUCCESSFULLY PERFORMED WITH A 23MM 9755RSL AORTIC VALVE. THE PATIENT WAS STABLE POST-PROCEDURE.

  Patient problems: Fatigue

  MAUDE report 22029894 ↗
• InjuryMay 9, 2025Insufficient Device Problem Information; Device Stenosis; Insufficient Device Problem Information; Device Stenosis

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 23MM 8300AB AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 7 YEARS, 9 MONTHS DUE TO UNKNOWN REASON. THE EXPLANTED VALVE WAS REPLACED WITH A 25MM 11500A VALVE. PER IDC 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: Insufficient Information

  MAUDE report 21996220 ↗
• InjuryApr 30, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT WITH A 23MM 8300AB AORTIC VALVE HAS BEEN PLACED UNDER EVALUATION FOR A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 7 YEARS, 1 MONTHS DUE TO UNKNOWN REASONS.

  Patient problems: Insufficient Information

  MAUDE report 21937474 ↗
• InjuryMar 14, 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 23MM 8300AB AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 3 YEARS DUE TO BACTERIAL ENDOCARDITIS. THE EXPLANTED VALVE WAS REPLACED WITH A 25MM 11060A AORTIC VALVED CONDUIT (AVC). PER MEDICAL RECORDS THE PATIENT DEVELOPED ACUTE BACTERIAL ENDOCARDITIS AND UNDERWENT REDO AVR, REDO BENTALL PROCEDURE, MVR WITH 25MM MITRIS, AND CLOSURE OF VSD/ASD. INTRAOPERATIVE FINDINGS, ROOT ABSCESS, VENTRICULAR SEPTUM AND AORTO-MITRAL CURTAIN WERE INVOLVED. THE PREVIOUS GRAFT/VALVE WERE REMOVED, AFTER ALL INFECTED TISSUE DEBRIDED, A 25MM AVC WAS IMPLANTED WITH SUTURES AND SECURED WITH COR-KNOTS. THE PATIENT WAS TRANSFERRED TO THE ICU IN STABLE CONDITION AND WAS DISCHARGED ON POD #12.

  Patient problems: Endocarditis; Insufficient Information

  MAUDE report 21608042 ↗
• InjuryFeb 10, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT WITH A 23MM 8300AB INTUITY VALVE UNDERWENT VALVE-IN-VALVE INTERVENTION AFTER AN IMPLANT DURATION OF SEVEN (7) YEARS, SEVEN (7) MONTHS DUE TO UNKNOWN REASONS. THE TAVR PROCEDURE WAS PERFORMED WITH A 26MM 9755RSL TRANSCATHETER VALVE. THE CASE WENT AS PLANNED WITH A SUCCESSFUL VALVE DEPLOYMENT.

  Patient problems: Insufficient Information

  MAUDE report 21351358 ↗
• InjuryJan 9, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED VIA THE PATIENT REGISTRY THAT A PATIENT WITH A 23MM 8300AB AORTIC VALVE UNDERWENT REDO AORTIC VALVE REPLACEMENT AFTER AN IMPLANT DURATION OF SIX (6) YEARS, SIX (6) MONTHS DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH A 29MM 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 21120416 ↗
• InjuryNov 14, 2024Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 23MM 8300AB INTUITY VALVE UNDERWENT VALVE-IN-VALVE INTERVENTION AFTER AN IMPLANT DURATION OF THREE (3) YEARS, ONE (1) MONTH DUE TO AORTIC STENOSIS WITH A MEAN GRADIENT OF 52MMHG. THE PATIENT INITIALLY PRESENTED WITH FATIGUE AND DYSPNEA WITH NORMAL ACTIVITY. THE TAVR PROCEDURE WAS PERFORMED WITH A 26MM NON-EDWARDS TRANSCATHETER VALVE. THE PATIENT RECOVERED WELL AND WAS NOTED TO BE FEELING DRAMATICALLY BETTER.

  Patient problems: Dyspnea; Fatigue

  MAUDE report 20687117 ↗
• InjuryOct 25, 2024Device Stenosis; Device Stenosis

  IT WAS REPORTED A PATIENT WITH A 23MM 8300AB AORTIC VALVE IMPLANTED FIVE (5) YEARS, NINE (9) MONTHS, UNDERWENT VALVE-IN-VALVE PROCEDURE DUE TO AORTIC STENOSIS. PATIENT PRESENTED WITH SHORTNESS OF BREATH. TAVR WAS SUCCESSFULLY PERFORMED WITH A 23MM 9750TFX TRANSCATHETER VALVE. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TRANSFERRED TO STEPDOWN UNIT IN STABLE CONDITION.

  Patient problems: Dyspnea

  MAUDE report 20534427 ↗
• InjuryAug 26, 2024Calcified; Calcified

  IT WAS REPORTED THAT A 23MM 8300AB VALVE IN THE AORTIC POSITION UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 7 YEARS 2 MONTHS DUE TO LEAFLET CALCIFICATION. THE PATIENT PRESENTED WITH SYNCOPE. THE TAVR WAS PERFORMED WITH A 23MM 9750TFX TRANSCATHETER VALVE. THE PATIENT WAS DISCHARGED ON POD # 1.

  Patient problems: Syncope/Fainting

  MAUDE report 20071224 ↗
• InjuryAug 21, 2024Perivalvular Leak; Perivalvular Leak

  THROUGH IMPLANT PATIENT REGISTRY AND MEDICAL RECORDS, IT WAS LEARNED A 23MM 8300AB AORTIC VALVE, WAS EXPLANTED AFTER AN IMPLANT DURATION OF FOUR (4) MONTHS DUE TO A PARAVALVULAR LEAK RESULTING IN REGURGITATION. THE PATIENT PRESENTED TO THE HOSPITAL WITH HEART FAILURE AND PROGRESSIVE DYSPNEA. THE EXPLANTED DEVICE WAS REPLACED WITH A 27MM 11500A VALVE. PER MEDICAL RECORDS, PATIENT PRESENTED TO OSH 06/2024 IN THE SETTING OF DECOMPENSATED HEART FAILURE. A TEE AT THAT TIME REVEALED PVL ON THE BIOPROSTHETIC VALVE PLACED 03/2024. THE PATIENT WAS DISCHARGED HOME AND REFERRED TO ANOTHER FACILITY FOR SURGICAL EVALUATION. REPEAT IMAGING REVEALED SEVERE PVL AND THE 23MM 8300AB TO BE UNSTABLE. THE PATIENT UNDERWENT A RE-DO AVR WITH A 27MM 11500A. INTRAOPERATIVELY, A LARGE GAP WAS NOTED BETWEEN THE NATIVE AORTIC ANNULUS AND BIOPROSTHETIC VALVE WHICH WAS DETERMINED TO BE THE CAUSE OF A SEVERE PVL AS WELL AS AN INCOMPLETE DEBRIDEMENT WITH EXTENSIVE CALCIFICATION OF THE AORTIC ANNULUS. THE 23MM 11500A VALVE WAS EXPLANTED, THE ANNULUS WAS METICULOUSLY DEBRIDED AND A 27MM 11500A WAS SEATED. A FINAL POST-BYPASS TEE REVEALED A MEAN GRADIENT OF 10MMHG ACROSS THE AORTIC PROSTHESIS WITH NO PVL IDENTIFIED.

  Patient problems: Dyspnea; Heart Failure/Congestive Heart Failure

  MAUDE report 20013153 ↗