EDWARDS INTUITY ELITE AORTIC VALVE 8300AB (REF 8300AB19A)Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00690103194470), received between Jan 28, 2021 and Aug 14, 2025 — classified as 24 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjuryAug 14, 2025Perivalvular Leak; Perivalvular Leak

  IT WAS REPORTED THAT A PATIENT WITH A 19MM 8300AB AORTIC VALVE UNDERWENT A PVL PLUG PLACEMENT PROCEDURE AFTER AN IMPLANT DURATION OF 3 MONTHS DUE TO SEVERE PVL. THE PATIENT PRESENTED WITH HEART FAILURE AND HEMOLYSIS. THE PHYSICIAN TREATED THE PVL WITH A NON-EDWARDS' PLUG DEVICE. THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: Dyspnea; Heart Failure/Congestive Heart Failure; Hemolysis; Hemolytic Anemia

  MAUDE report 22805024 ↗
• InjuryJul 8, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT WITH A 19MM 8300AB AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 5 YEARS, 3 MONTHS DUE TO UNKNOWN REASON. THE TAVR WAS SUCCESSFULLY PERFORMED WITH A 20MM 9750TFX VALVE WITHOUT ISSUES AND THE PATIENT IS STABLE.

  Patient problems: Insufficient Information

  MAUDE report 22437634 ↗
• InjuryMar 11, 2025Calcified; Calcified

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A PATIENT WITH A 19MM 8300AB AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 7 YEARS, 5 MONTHS DUE TO CALCIFICATION. THE PATIENT PRESENTED WITH SHORTNESS OF BREATH. THE EXPLANTED VALVE WAS REPLACED WITH A 23MM 11500A VALVE. THE PATIENT WAS TAKEN TO RECOVERY POST PROCEDURE AND DISCHARGES ON POD #1. 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 21573372 ↗
• InjuryFeb 5, 2025Degraded; Insufficient Device Problem Information; Device Stenosis; Degraded; Insufficient Device Problem Information; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 19MM 8300AB AORTIC VALVE IS BEING WORKED UP FOR A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF SEVEN (7) YEARS, TWO (2) MONTHS DUE TO DEGENERATION AND STENOSIS. THE PATIENT PRESENTED WITH SHORTNESS OF BREATH.

  Patient problems: Dyspnea; Insufficient Information

  MAUDE report 21314813 ↗
• InjuryJan 23, 2025Calcified; Fluid/Blood Leak; Difficult to Open or Close; Device Stenosis; Calcified; Fluid/Blood Leak; Difficult to Open or Close; Device Stenosis

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A 19MM 8300AB AORTIC VALVE, WAS EXPLANTED AFTER AN IMPLANT DURATION OF SIX (6) YEARS, THREE (3) MONTHS DUE TO MILD CALCIFICATION WITH LEAFLET IMMOBILITY AND TEARS, STENOSIS AND REGURGITATION. THE EXPLANTED VALVE WAS REPLACED WITH A 23MM 3300TFX VALVE. PER MEDICAL RECORDS, THE PATIENT PRESENTED WITH PROGRESSIVE DYSPNEA AND WAS FOUND TO HAVE MIXED AORTIC STENOSIS AND INSUFFICIENCY, AND RECURRENT TRICUSPID REGURGITATION. THE PATIENT UNDERWENT A REDO AVR, ANNULAR ENLARGEMENT WITH BOVINE PATCH, AND TRICUSPID VALVE REPLACEMENT. THE AV WAS SEVERELY ADHERENT TO SURROUNDING AORTA REQUIRING EXTENSIVE DEBRIDEMENT TO EXCISE. THE ANNULUS WAS SMALL, REQUIRED ENLARGEMENT TO ALLOW A 23MM 3300TFX VALVE TO BE IMPLANTED. THE NATIVE TRICUSPID VALVE WAS DILATED WITH FRAGILE LEAFLETS. THE PREVIOUS 30MM RING WAS EXPLANTED, INITIAL ATTEMPT WAS MADE TO REPAIR THE VALVE BY DOWNSIZING TO A 28MM 4900 TRICUSPID RING. AFTER COMING OFF CPB, TEE SHOWED RESIDUAL 2-3+ TRICUSPID REGURGITATION. THE DECISION WAS MADE TO GO BACK ON CPB AND REPLACED THE RING WITH A 31MM EPIC NON-EDWARDS VALVE. TEE SHOWED GOOD FUNCTION OF THE AORTIC AND TRICUSPID VALV

  Patient problems: Dyspnea

  MAUDE report 21222002 ↗
• InjuryJan 10, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED AND THROUGH INVESTIGATION THAT A PATIENT WITH A 19MM 8300AB AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 7 YEARS, 4 MONTHS DUE TO STENOSIS. THE PATIENT PRESENTED WITH DIZZINESS AND FATIGUE. THE PROCEDURE WAS PERFORMED SUCCESSFULLY WITH A 20MM 9755RSL TRANSCATHETER VALVE. PATIENT LEFT THE OR WITH STABLE VITALS AND WAS TAKEN TO RECOVERY.

  Patient problems: Dizziness; Fatigue

  MAUDE report 21131894 ↗
• InjurySep 3, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THROUGH IMPLANT PATIENT REGISTRY IT WAS LEARNED A 19MM 8300AB AORTIC VALVE IMPLANTED SEVEN (7) YEARS, EIGHT (8) MONTHS, WAS EXPLANTED DUE TO UNKNOWN REASONS. THE EXPLANTED DEVICE WAS REPLACED WITH A 21MM 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 20126725 ↗
• InjuryJul 3, 2024Calcified; Calcified

  IT WAS REPORTED THAT A PATIENT WITH A 19MM 8300AB AORTIC VALVE IN AORTIC POSITION IS UNDER EVALUATION FOR A POSSIBLE VALVE IN VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 7 YEARS, 2 MONTHS DUE TO CALCIFICATION. TAVR HAS NOT BEEN SCHEDULED.

  Patient problems: Insufficient Information

  MAUDE report 19667035 ↗
• InjuryJun 13, 2024Device Stenosis; Device Stenosis

  IT WAS LEARNED THROUGH THE IMPLANT PATIENT REGISTRY THAT A 19MM 8300AB AORTIC VALVE, WAS EXPLANTED AFTER AN IMPLANT DURATION OF FOUR (4) YEARS, SIX (6) MONTHS DUE TO STENOSIS. THE PATIENT PRESENTED WITH DYSPNEA. THE EXPLANTED VALVE WAS REPLACED WITH A 25MM 11500A VALVE. PER MEDICAL RECORDS, PATIENT HAD SEVERE LVOT NARROWING AND AORTIC STENOSIS THAT REQUIRED A KONNO ANTERIOR VENTRICULAR SEPTAL MYOPLASTY. INTRAOPERATIVELY, THE VALVE LEAFLETS DID NOT LOOK GROSSLY DYSMORPHIC, BUT IT WAS A CLEAR THAT THIS WAS A SMALL VALVE. A RIGHT VENTRICULOTOMY WAS MADE AND THE INCISION WAS CARRIED DOWN THE COMMISUE BETWEEN THE RIGHT AND LEFT CORONARY SINUSES TO CREATE A VENTRICULAR SEPTAL DEFECT CONNECTION. A BOVINE PERICARDIAL PATCH WAS USED TO PATCH THE LEFT VENTRICULAR SIDE UP THROUGH THE RV ALL THE WAY UP THE ANNULAR JUNCTION. A SEPARATE 4-0 PROLENE SUTURE WAS USED TO DO A SECONDARY HEMOSTATIC LAYER ON THE RV SIDE. THE PATIENT'S ANNULUS WAS INCREASED FROM 19MM TO 25 WITH A WIDE OPEN LVOT. A 25MM 11500 VALVE WAS SUTURED IN PLACE. THERE WAS NO RESIDUAL VENTRICULAR SEPTAL DEFECT AD THE PULMONARY VALVE WAS UNAFFECTED. THE PATIENT WAS WEANED OFF CARDIOPULMONARY BYPASS. BOTH ECHO AND VISUAL GUIDANCE WE

  Patient problems: Dyspnea

  MAUDE report 19530159 ↗
• InjuryJun 11, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 19MM 8300AB AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF SIX (6) YEARS, THREE (3) MONTHS DUE TO UNKNOWN REASON. THE PROCEDURE WAS PERFORMED WITH A 20MM 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 19515803 ↗
• InjuryJun 11, 2024Calcified; Insufficient Device Problem Information; Calcified; Insufficient Device Problem Information

  IT WAS REPORTED THAT A 19MM 8300AB IN THE AORTIC POSITION, UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 7 YEARS, 7 MONTHS DUE TO CALIFICATION AND STENOSIS. THE PATIENT PRESENTED WITH HEART FAILURE, DYSPNEA, LE EDEMA, AND FATIGUE. THE TAVR WAS PERFORMED WITH A 20MM 9755RSL TRANSCATHETER VALVE.

  Patient problems: Dyspnea; Fatigue; Heart Failure/Congestive Heart Failure; Insufficient Information; Swelling/ Edema

  MAUDE report 19510848 ↗
• InjuryJun 5, 2024Perivalvular Leak; Perivalvular Leak

  IT WAS REPORTED THAT PATIENT WITH A 19MM 8300AB AORTIC VALVE, UNDERWENT AN AMPLATZER OCCLUDER PLUG PROCEDURE AFTER AN IMPLANT DURATION OF SIX (6) MONTHS DUE TO PVL.

  Patient problems: Insufficient Information

  MAUDE report 19473301 ↗
• InjuryJun 5, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT PATIENT WITH A 19MM 8300AB AORTIC VALVE, UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF SEVEN (7) YEARS, SEVEN (7) MONTHS DUE TO AORTIC INSUFFICIENCY. THE PATIENT PRESENTED WITH HEART FAILURE, AND SHORTNESS OF BREATH. THE PROCEDURE WAS PERFORMED WITH A 20MM 9755RSL VALVE. ON POD #1, THE PATIENT WAS DISCHARGED IN STABLE CONDITION.

  Patient problems: Dyspnea; Heart Failure/Congestive Heart Failure

  MAUDE report 19473095 ↗
• InjuryMay 2, 2024Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 19MM 8300AB INTUITY VALVE IN THE AORTIC POSITION WAS PLACED UNDER EVALUATION FOR VALVE-IN-VALVE INTERVENTION AFTER AN IMPLANT DURATION OF FIVE (5) YEARS, THREE (3) MONTHS DUE TO AORTIC STENOSIS.

  Patient problems: Insufficient Information

  MAUDE report 19231263 ↗
• InjuryApr 16, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 19MM 8300AB AORTIC VALVE, UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF SIX (6) YEARS, TEN (10) MONTHS DUE TO UNKNOWN REASON. THE PROCEDURE WAS PERFORMED WITH A 29MM 9755RSL 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 19120195 ↗
• InjuryApr 9, 2024Device Stenosis; Device Stenosis

  IT WAS LEARNED VIA THE PATIENT REGISTRY THAT A PATIENT WITH A 19MM 8300AB INTUITY VALVE IN AORTIC POSITION UNDERWENT A REDO AORTIC VALVE REPLACEMENT PROCEDURE AFTER AN IMPLANT DURATION OF SIX (6) YEARS, FOUR (4) MONTHS AND 24 DAYS DUE TO AORTIC STENOSIS. THE PATIENT INITIALLY PRESENTED WITH SHORTNESS OF BREATH AND DIZZINESS. THE EXPLANTED VALVE WAS REPLACED WITH A 25MM 11500A INSPIRIS VALVE. THE PATIENT WAS NOTED TO BE IN STABLE CONDITION POST PROCEDURE.

  Patient problems: Dizziness; Dyspnea

  MAUDE report 19074941 ↗
• InjuryJan 25, 2024Gradient Increase; Perivalvular Leak; Gradient Increase; Perivalvular Leak

  IT WAS REPORTED THAT A PATIENT WITH A 19MM 8300AB VALVE IN THE AORTIC POSITION, UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF FOUR (4) YEARS, THREE (3) MONTHS DUE TO STENOSIS AND PERIVALVULAR REGURGITATION. THE PATIENT PRESENTED WITH WORSENING SHORTNESS OF BREATH, LE EDEMA, DIZZINESS, AND FATIGUE. THE TAVR WAS PERFORMED WITH A 20MM 9755RSL TRANSCATHETER VALVE.

  Patient problems: Dizziness; Dyspnea; Fatigue; Swelling/ Edema

  MAUDE report 18581498 ↗
• InjurySep 18, 2023Degraded; Insufficient Device Problem Information; Degraded; Insufficient Device Problem Information

  IT WAS REPORTED A PATIENT WITH A 19MM 8300AB AORTIC VALVE IMPLANTED SIX (6) YEARS, UNDERWENT VALVE-IN-VALVE PROCEDURE DUE TO DEGENERATION. PATIENT PRESENTED WITH SHORTNESS OF BREATH AND FATIGUE. TAVR WAS SUCCESSFULLY PERFORMED WITH A 20MM 9755RSL TRANSCATHETER VALVE. THE PATIENT WAS STABLE AT THE END OF THE PROCEDURE AND WAS DISCHARGED ON POD# 1.

  Patient problems: Dyspnea; Fatigue; Insufficient Information

  MAUDE report 17769754 ↗
• InjurySep 11, 2023Gradient Increase; Patient-Device Incompatibility; Insufficient Device Problem Information; Gradient Increase; Patient-Device Incompatibility; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND MEDICAL RECORDS THAT A 19MM 8300AB AORTIC VALVE IN AORTIC POSITION WAS EXPLANTED AFTER AN IMPLANT DURATION OF FOUR(4) YEARS, NINE (9)MONTHS AND 14 DAYS DUE TO SMALL UNDERSIZED VALVE WITH SEVERE AORTIC STENOSIS. THE PATIENT PRESENTED WITH NSTEMI. THE REPLACEMENT VALVE IS A 21MM 11500A AORTIC VALVE. THE PATIENT WAS DISCHARGED ON POD# 7. THE PATIENT UNDERWENT REDO STERNOTOMY AND REDO AVR. THE PATIENT UNDERWENT CONCOMITANT MVR WITH A 25MM MITRIS VALVE. THE ECHO SHOWED THE VALVES WORKING WELL WITH NO PVL. THE PATIENT TOLERATED THE PROCEDURE WELL AND TRANSFERRED TO ICU.

  Patient problems: Insufficient Information; Myocardial Infarction

  MAUDE report 17726348 ↗
• InjuryAug 30, 2023Fluid/Blood Leak; Gradient Increase; Fluid/Blood Leak; Gradient Increase

  IT WAS REPORTED THAT A 19MM 8300AB INTUITY AORTIC VALVE WAS EXPLANTED AND REPLACED WITH A 21MM 11500A INSPIRIS VALVE AFTER AN IMPLANT DURATION OF FOUR YEARS, NINE MONTHS DUE A GRADIENT OF 40MMHG AND MILD TO MODERATE REGURGITATION. THE CASE WENT WITHOUT COMPLICATION AND THE PATIENT IS DOING WELL. THE PATIENT UNDERWENT CONCOMITANT MV REPAIR WITH A 28MM 5200 PHYSIO 11 RING. THE IS A 58-YEAR-OLD FEMALE.

  Patient problems: Insufficient Information; Myocardial Infarction

  MAUDE report 17657544 ↗
• InjuryMay 31, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED VIA THE PATIENT REGISTRY THAT A PATIENT WITH A 19MM 8300AB PERICARDIAL AORTIC VALVE UNDERWENT A REDO AORTIC VALVE REPLACEMENT PROCEDURE AFTER AN IMPLANT DURATION OF FOUR (4) YEARS, FIVE (5) MONTHS DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH A 21MM 11500A PERICARDIAL VALVE.

  Patient problems: Insufficient Information

  MAUDE report 14548501 ↗
• InjuryApr 29, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED VIA IMPLANT PATIENT REGISTRY THAT A 19MM 8300AB AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 4 YEARS, 5 MONTHS DUE TO UNKNOWN REASON. THE EXPLANTED VALVE WAS REPLACED WITH A 21MM 11500A AORTIC VALVE. 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 14255406 ↗
• InjurySep 28, 2021Calcified; Fluid/Blood Leak; Gradient Increase; Calcified; Fluid/Blood Leak; Gradient Increase

  IT WAS REPORTED THAT A PATIENT WITH A 19MM 8300AB INTUITY VALVE, IMPLANTED IN THE AORTIC POSITION, UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF THREE (3) YEARS, SEVEN (7) MONTHS DUE TO STENOSIS AND REGURGITATION. THE PATIENT UNDERWENT INTENTIONAL FRACTURE OF SURGICAL VALVE WITH A 22MM ATLAS GOLD BALLOON. THE TAVR WAS PERFORMED SUCCESSFULLY WITH A 23MM 9750TFX TRANSCATHETER VALVE WITH NO COMPLICATIONS. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

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

  MAUDE report 12542518 ↗
• InjuryJan 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EDWARDS RECEIVED INFORMATION THAT ATRIAL FIBRILLATION WAS DETECTED ON THE FOLLOWING DAY OF THE IMPLANTATION SURGERY OF A 19MM 8300AB AORTIC VALVE. THIS DEVICE WAS ORIGINALLY IMPLANTED TO CORRECT AORTIC STENOSIS AND REGURGITATION SECONDARY TO MILD CALCIFICATION. ATRIAL FIBRILLATION ALMOST DISAPPEARED BY PACING, MEDICATION, AND REMOVING WATER. THE PATIENT STATUS WAS REPORTED AS 'RECOVERED'. THE SURGEON COMMENTED THAT IT WAS UNKNOWN WHETHER THIS EVENT WAS DEVICE RELATED, AND IT WAS LIKELY DUE TO PRESSURE LOAD TO THE ATRIUM. OF NOTE, A MVR WAS ALSO PERFORMED AT THE INITIAL SURGERY.

  Patient problems: Atrial Fibrillation

  MAUDE report 11247985 ↗