EDWARDS INTUITY ELITE AORTIC VALVE 8300AB (REF 8300AB25A)Recalls & reported problems

Summary

The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 00690103194500), received between May 5, 2021 and Mar 20, 2026 — classified as 1 death, 51 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (17 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 52 reports, in the reporter's own words as published by the FDA.

• InjuryMar 20, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 25MM 8300AB AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 7 YEARS, 6 MONTHS DUE TO UNKNOWN REASON. THE EXPLANTED VALVE WAS REPLACED WITH A 25MM 11060A 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: Aneurysm; Insufficient Information

  MAUDE report 24655981 ↗
• InjuryMar 2, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 25MM 8300AB AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 4 YEARS, 6 MONTHS DUE TO UNKNOWN REASON. THE EXPLANTED VALVE WAS REPLACED WITH A 23MM11500A 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

  MAUDE report 24491536 ↗
• InjuryFeb 19, 2026Device Stenosis

  IT WAS REPORTED VIA CLINICAL SAFETY THAT A PATIENT WITH A 25MM 8300AB AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 8 YEARS, 11 MONTHS DUE TO STENOSIS. PATIENT PRESENTED WITH SHORTNESS OF BREATH AND FATIGUE. THE PROCEDURE WAS PERFORMED WITH A 23MM 9755RSL TRANSCATHETER VALVE. THE PATIENT TOLERATED THE PROCEDURE WELL WITHOUT COMPLICATION AND TRANSFERRED TO ICU IN STABLE CONDITION. THE PATIENT DISCHARGED ON POD#3.

  Patient problems: Dyspnea

  MAUDE report 24392782 ↗
• DeathJan 30, 2026Calcified

  IT WAS REPORTED THAT A PATIENT WITH A 25MM 8300AB AORTIC VALVE HAS BEEN PLACED UNDER EVALUATION FOR A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 8 YEARS DUE TO SEVERELY CALCIFIED LEAFLETS, SEVERE STENOSIS, AND REGURGITATION. THE PATIENT PRESENTED WITH SYMPTOMS OF HEART FAILURE. PER FCS, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE REPLACEMENT AT PENROSE HOSPITAL. PER VCC/FCS, THE PATIENT PASSED AWAY THIS PAST WEEKEND ((B)(6) 2026) PRIOR TO PLANNED VIV PROCEDURE. HE HAD HEART BLOCK RELATED CARDIAC ARREST AND EXPIRED IN THE HOSPITAL.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 24223840 ↗
• InjuryJan 7, 2026Perivalvular Leak

  IT WAS REPORTED THAT A 8300AB 25MM AORTIC VALVE WAS EXPLANTED ON POD #7 DUE TO PERIVALVULAR LEAK. A 8300AB 27MM WAS IMPLANTED IN REPLACEMENT. AS REPORTED THE SIZERS HAD GOOD FIT IN THE ANNULUS, HOWEVER SURGEON STATED THERE WAS DIFFICULTY SEATING THE VALVE. PER MEDICAL RECORDS THE PATIENT INITIALLY UNDERWENT AVR AND CABG X 2. THE PATIENT HAD EXTENSIVE CALCIFICATION OF THE ASCENDING AORTA THAT WAS REMOVED ON THE LEFT SIDE. THERE WAS GOOD APPOSITION OF THE VALVE TO THE ANNULUS AND THE PATIENT WAS TRANSFERRED TO ICU IN STABLE CONDITION. POST-OPERATIVE ECHO SHOWED PERIVALVULAR LEAK. ON POD #7 THE PATIENT UNDERWENT REDO-AVR AND AORTIC ROOT ENLARGEMENT. THE LEAK WAS FOUND BETWEEN THE RIGHT AND THE LEFT CORONARY CUSP. THIS WAS MOSTLY PERIVALVULAR LEAK AROUND THE STENT OF THE VALVE. A NEW 8300AB VALVE WAS USED IN REPLACEMENT WITH GOOD APPOSITION TO THE ANNULUS. THE PATIENT WAS TRANSFERRED TO ICU IN STABLE CONDITION. PER PRODUCT EVALUATION CUSTOMER REPORTS OF DIFFICULTY SEATING AND PERIVALVULAR LEAK WERE UNABLE TO BE CONFIRMED THROUGH VISUAL OBSERVATIONS. AS RECEIVED, LEAFLET 1 HAD A 6MM CUT NEAR COMMISSURE 1 AND EDGES OF CUT APPEARED TO MATCH UP. REFERENCE MEASUREMENTS WERE TAKEN; THE EXTER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23992591 ↗
• InjuryDec 15, 2025Device Stenosis; Device Stenosis

  IT WAS LEARNED VIA THE PATIENT REGISTRY THAT A PATIENT WITH A 25MM 8300AB INTUITY VALVE IN THE AORTIC POSITION UNDERWENT REDO AORTIC VALVE REPLACEMENT AFTER AN IMPLANT DURATION OF SEVEN (7) YEARS, NINE (9) MONTHS DUE TO AORTIC STENOSIS AND REGURGITATION. THE PATIENT INITIALLY PRESENTED WITH HEART FAILURE AND SHORTNESS OF BREATH. THE EXPLANTED VALVE WAS REPLACED WITH A 25MM 11500A INSPIRIS VALVE. THE PATIENT WENT TO ICU POST SURGERY AND THEN WAS DISCHARGED HOME 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: Dyspnea; Heart Failure/Congestive Heart Failure

  MAUDE report 23811465 ↗
• InjuryOct 24, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED VIA THE PATIENT REGISTRY THAT A PATIENT WITH A 25MM 8300AB INTUITY VALVE IN THE AORTIC POSITION UNDERWENT REDO AORTIC VALVE REPLACEMENT AFTER AN IMPLANT DURATION OF EIGHT (8) YEARS, FIVE (5) 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 23382564 ↗
• InjuryOct 15, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A PATIENT WITH A 25MM 8300AB AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 7 YEARS, 7 MONTHS DUE TO POOR LEAFLET MOBILITY CAUSING STENOSIS AND MODERATE TO SEVERE REGURGITATION. THE PATIENT PRESENTED WITH SOB AND CHEST PAIN. THE PATIENT WAS TAKEN TO THE ICU 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: Dyspnea

  MAUDE report 23294320 ↗
• InjurySep 19, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 25MM 8300AB AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 7 YEARS, 4 MONTHS DUE TO STENOSIS (MG 41MMHG). THE PATIENT PRESENTED WITH SHORTNESS OF BREATH AND FATIGUE. THE TAVR PROCEDURE WAS SUCCESSFULLY PERFORMED WITH A 26MM 9755RSL VALVE. THE PATIENT WAS IN RECOVERY POST PROCEDURE AND DISCHARGED ON POD #2.

  Patient problems: Dyspnea; Fatigue; Insufficient Information

  MAUDE report 23095522 ↗
• InjuryAug 22, 2025Calcified; Perivalvular Leak; Calcified; Perivalvular Leak

  IT WAS LEARNED FROM IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A PATIENT WITH A 25MM 8300AB AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 8 YEARS, 5 MONTHS DUE TO CALCIFICATION WITH DEGENERATION, STENOSIS AND PVL. THE PATIENT PRESENTED WITH FATIGUE AND HEMOLYTIC ANEMIA. THE EXPLANTED VALVE WAS REPLACED WITH A 25MM 11500A VALVE. THE PATIENT WAS IN RECOVERY AND STABLE CONDITION POST PROCEDURE. PATIENT WAS DISCHARGE ON 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: Fatigue; Hemolytic Anemia

  MAUDE report 22879338 ↗
• InjuryAug 4, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 25MM 8300AB AORTIC VALVE BEEN PLACED UNDER CONSIDERATION FOR A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 6 YEARS, 3 MONTHS DUE TO SEVERE STENOSIS. THE PATIENT PRESENTED WITH FATIGUE.

  Patient problems: Fatigue

  MAUDE report 22708467 ↗
• InjuryJul 14, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 25MM 8300AB AORTIC VALVE HAS BEEN PLACED UNDER EVALUATION FOR A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 6 YEARS DUE TO AORTIC STENOSIS AND INSUFFICIENCY.

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

  MAUDE report 22495209 ↗
• InjuryJul 2, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT WITH A 8300AB 25MM AORTIC VALVE IS BEING EVALUATED FOR A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 7 YEARS, 10 MONTHS DUE TO UNKNOWN REASONS.

  Patient problems: Insufficient Information

  MAUDE report 22383714 ↗
• InjuryJun 30, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED AND LEARNED THROUGH MEDICAL RECORDS THAT A PATIENT WITH A 25MM 8300AB INTUITY AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 2 YEARS, 4 MONTHS DUE TO SEVERE AORTIC STENOSIS AND MODERATE AORTIC INSUFFICIENCY. THE PATIENT PRESENTED DYSPNEA ON EXERTION. THE TAVR WAS PERFORMED WITH A 26MM 9750TFX TRANSCATHETER VALVE. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS DISCHARGED ON POD#1. PER MEDICAL RECORDS, THE PATIENT PRESENTED WITH WORSENING EXERTIONAL CHEST PRESSURE AND DOE. TEE AND ECHOCARDIOGRAM DEMONSTRATED SEVERE AORTIC STENOSIS WITH HIGH GRADIENT. THE PATIENT UNDERWENT TAVR PROCEDURE AND 26MM 9750TFX TRANSCATHETER VALVE WAS DEPLOYED SUCCESSFULLY WITHOUT COMPLICATIONS. TEE DEMONSTRATED A WELL SEATED VALVE WITH A MEAN GRADIENT OF 12 MMHG. THE PATIENT WAS DISCHARGED ON POD #1.

  Patient problems: Dyspnea

  MAUDE report 22358053 ↗
• InjuryJun 16, 2025Intravalvular regurgitation; Intravalvular regurgitation

  IT WAS REPORTED AND LEARNED THROUGH INVESTIGATION THAT A PATIENT WITH A 25MM 8300AB AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 7 YEARS, 3 MONTHS DUE TO SEVERE REGURGITATION AND STENOSIS. THE PATIENT PRESENTED WITH SOB AND HYPOXIA. THE PROCEDURE WAS PERFORMED WITH A 26MM 9755RSL TRANSCATHETER VALVE. THE PATIENT WAS TAKEN TO RECOVERY IN STABLE CONDITION POST PROCEDURE.

  Patient problems: Dyspnea; Hypoxia

  MAUDE report 22213346 ↗
• InjuryJun 1, 2025Device Stenosis; Unspecified Valve Regurgitation; Device Stenosis; Unspecified Valve Regurgitation

  IT WAS REPORTED AND LEARNED THROUGH INVESTIGATION THAT A PATIENT WITH A 25MM 8300AB AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 8 YEARS, 4 MONTHS DUE TO REGURGITATION AND STENOSIS. PATIENT PRESENTED WITH HEART FAILURE. THE PROCEDURE WAS PERFORMED WITH A 26MM 9750TFX TRANSCATHETER VALVE. PATIENT WAS STABLE AND WAS DISCHARGED ON POD#2. THIS IS AN 80-YEAR-OLD MALE PATIENT.

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

  MAUDE report 22121352 ↗
• InjuryMay 28, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 25MM 8300AB AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 5 YEARS AND 1 MONTH DUE TO UNKNOWN REASON. THE VALVE WAS REPLACED WITH A 11500A 27MM BIOPROSTHETIC 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 22097534 ↗
• InjuryMay 27, 2025Calcified; Calcified

  IT WAS REPORTED AND LEARNED THROUGH INVESTIGATION THAT A PATIENT WITH A 25MM 8300AB AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF EIGHT (8) YEARS, SIX (6) MONTHS DUE TO CALCIFICATION, DEGENERATION, AND STENOSIS. THE PATIENT PRESENTED WITH SYMPTOMS OF HEART FAILURE - SHORTNESS OF BREATH. THE PROCEDURE WAS PERFORMED WITH A 26MM 9755RSL TRANSCATHETER VALVE SUCCESSFULLY. PATIENT WAS IN STABLE CONDITION POST PROCEDURE AND WAS DISCHARGED ON POD #6.

  Patient problems: Dyspnea; Heart Failure/Congestive Heart Failure

  MAUDE report 22092247 ↗
• InjuryMay 8, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 25MM 8300AB VALVE, IMPLANTED IN AORTIC POSITION, WAS EXPLANTED AFTER AN IMPLANT DURATION OF 7 YEARS AND 5 MONTHS DUE TO UNKNOWN REASON. THE VALVE WAS REPLACED WITH A 11500M VALVE.

  Patient problems: Insufficient Information

  MAUDE report 21990510 ↗
• InjuryApr 22, 2025Calcified; Calcified

  IT WAS REPORTED AND LEARNED THROUGH MEDICAL RECORDS THAT A PATIENT WITH A 25MM 8300AB AORTIC VALVE HAS BEEN PLACED UNDER CONSIDERATION FOR A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 4 YEARS, 10 MONTHS DUE TO CALCIFICATION. THE PATIENT PRESENTED WITH HEART FAILURE AND SEVERE SOB. THE TAVR HAS NOT BEEN SCHEDULED AT THIS TIME. PER MEDICAL RECORDS, ECHO (B)(6) 2025) REVEALED SEVERE AORTIC STENOSIS.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 21886250 ↗
• InjuryFeb 5, 2025Insufficient Device Problem Information; Intravalvular regurgitation; Insufficient Device Problem Information; Intravalvular regurgitation

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 25MM 8300AB AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 5 YEARS, 10 MONTHS DUE TO REGURGITATION. THE PATIENT PRESENTED WITH HEART FAILURE AND SHORTNESS OF BREATH. THE TAVR WAS PERFORMED WITH A 26MM 9750TFX TRANSCATHETER VALVE. THE PATIENT WAS STABLE POST PROCEDURE AND DISCHARGED ON POD #4.

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

  MAUDE report 21314070 ↗
• InjuryJan 20, 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 25MM 8300AB AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 2 YEARS, 2 MONTHS DUE TO ENDOCARDITIS (STREP SANGUINIS). THE EXPLANTED VALVE WAS REPLACED WITH A 23MM 11500A VALVE. THE PATIENT WAS IN RECOVERY POST PROCEDURE. PER MEDICAL RECORDS, THE PATIENT PRESENTED WITH EPIGASTRIC PAIN, DYSPNEA AND GENERALIZED WEAKNESS, AND WAS INITIALLY DIAGNOSED WITH RENAL INFARCTS, STREP SANGUINIS BACTEREMIA AND ENDOCARDITIS. PATIENT WAS STARTED ON IV ANTIBIOTICS. THE PATIENT UNDERWENT REDO-AVR WITH A 23MM 11500A VALVE. INTRAOPERATIVELY, THE PROSTHETIC AV LEAFLETS ARE SEVERELY THICKENED, WITH MOBILE ECHO DENSITIES SEEN INVOLVING THE NON-CORONARY AND LEFT CORONARY CUSPS. THE PATIENT TOLERATED THE PROCEDURE WELL, AND RECOVERED IN THE ICU. POD #4 ECHO SHOWED A WELL SEATED AV WITH NO REGURGITATION

  Patient problems: Endocarditis; Insufficient Information

  MAUDE report 21194367 ↗
• InjuryDec 10, 2024Calcified; Calcified

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A PATIENT WITH A 25MM 8300AB AORTIC VALVE, WAS EXPLANTED AFTER AN IMPLANT DURATION OF SIX (6) YEARS, ONE (1) MONTH DUE TO CALCIFICATION. THE PATIENT PRESENTED WITH SYMPTOMS OF HEART FAILURE. THE EXPLANTED VALVE WAS REPLACED WITH A 27MM 11500A VALVE. ON POD #1, THE PATIENT EXPIRED DUE TO POST-BYPASS PROTAMINE REACTION WITH CARDIOGENIC SHOCK. 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 20894358 ↗
• InjuryNov 8, 2024Perivalvular Leak; Perivalvular Leak

  IT WAS LEARNED THROUGH MEDICAL RECORDS (B)(6) THAT A 25MM 8300AB VALVE IMPLANTED IN THE AORTIC POSITION HAD PVL. PER MEDICAL RECORDS, THE PATIENT INITIALLY UNDERWENT REDO AVR AS A RESULT OF ENDOCARDITIS (B)(6) WITH PERIVALVULAR ABSCESSES, PARTIALLY DEHISCED WITH SLIGHT ROCKING MOTION, SEVERE PARAVALVULAR REGURGITATION. IT WAS DECIDED TO IMPLANT A 25MM 8300AB VALVE, EXPANDING IT TO HELP FILL THE ABSCESS CAVITIES. THE SUBANNULAR ABSCESS CAVITY HAD VERY POOR INTEGRITY, AND IT WAS STILL POSSIBLE TO DISTRACT THE TISSUES AROUND THE DEPLOYED VALVE. IT WAS DETERMINED THAT THERE WAS NO OTHER OPTION AND THE AORTOTOMY WAS THEN CLOSED. POST BYPASS TEE DEMONSTRATED SIGNIFICANT PARAVALVULAR LEAK, AS EXPECTED FOLLOWING INSPECTION OF THE DEPLOYED 25MM 8300AB VALVE. HOWEVER, THERE WAS SIMPLY NO OTHER WAY TO PROVIDE THE PATIENT WITH AN AORTIC VALVE, SO NO FURTHER INTERVENTIONS WERE PERFORMED. THE ABSCESS/INFECTION WAS SUBANNULAR AND HAD UNFORTUNATELY DESTROYED THE TISSUES TO THE POINT THAT FURTHER ATTEMPTS AT REPAIR WOULD UNDOUBTEDLY BE UNSUCCESSFUL. THE PATIENT WAS TAKEN INTO THE ICU IN CRITICAL CONDITION. THE PATIENT WAS TRANSITIONED TO COMFORT CARE MEASURES ONLY AND THE PATIENT EXPIRED ON POD#1.

  Patient problems: Insufficient Information

  MAUDE report 20642852 ↗
• InjuryNov 1, 2024Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 25MM 8300AB AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF SEVEN (7) YEARS DUE TO STENOSIS. THE TAVR WAS PERFORMED WITH A NON-EDWARDS DEVICE. THE PATIENT IS DOING WELL.

  Patient problems: Insufficient Information

  MAUDE report 20593760 ↗