KONECT RESILIA 11060A (REF 11060A23)Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00690103201383), received between Sep 17, 2021 and Jan 30, 2026 — classified as 1 death, 21 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (13 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 16, 2026.

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryJan 30, 2026Patient-Device Incompatibility

  IT WAS LEARNED THROUGH MEDICAL RECORDS RECEIVED THAT AFTER IMPLANT OF A 23MM 11060A AORTIC VALVED CONDUIT (AVC), THERE WAS SEVERE NATIVE MITRAL VALVE REGURGITATION. THE NATIVE MITRAL VALVE WAS REPLACED WITH A 25MM MITRIS VALVE. THE PATIENT UNDERWENT A REDO AVR FOR ENDOCARDITIS. A 23MM 11060A AVC WAS IMPLANTED IN REPLACEMENT AND THE VALVE ITSELF SEATED WELL. WHILE WEANING FROM BYPASS IT BECAME APPARENT THE NATIVE MITRAL VALVE WAS SEVERELY REGURGITANT, LIKELY SECONDARY TO ANTERIOR LEAFLET OF THE ANNULUS WAS RESTRICTED OR FORESHORTENED AS PART OF THE IMPLANTATION OF THE AVC IN THE LVOT. THE DECISION WAS MADE TO REPLACE THE MITRAL VALVE, TRANSSEPTAL APPROACH WAS USED BUT STILL DIFFICULTY VISUALIZING THE ANTERIOR LEAFLET. A 25MM MITRIS VALVE WAS IMPLANTED WITH PLEDGETED SUTURES AND SECURED WITH COR-KNOTS. POST CPB TEE SHOWED 23MM AVC AND THE 25MM MITRIS VALVE WELL-SEATED WITH NORMAL FUNCTION AND NO PVL. WHILE WEANING FROM BYPASS THERE WAS EXTENSIVE BLEEDING FROM THE PROXIMAL END OF THE AORTIC ROOT REPLACEMENT SUTURE LINE. DESPITE ATTEMPTS TO GAIN HEMOSTASIS, THE HEMORRHAGE WAS UNSURVIVABLE. THE DECISION WAS MADE TO STOP FURTHER RESUSCITATION AND THE PATIENT EXPIRED IN THE OR.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 24226224 ↗
• InjuryDec 1, 2025Device Dislodged or Dislocated; Insufficient Device Problem Information; Device Dislodged or Dislocated; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 23MM 11060A AORTIC VALVED CONDUIT WAS EXPLANTED AFTER AN IMPLANT DURATION OF 1 YEARS, 5 MONTHS DUE TO DEHISCENCE WITH PSEUDOANEURYSM. PATIENT PRESENTED WITH NYHA CLASS II HEART FAILURE AND FATIGUE. THE EXPLANTED VALVE WAS REPLACED WITH A 25MM 11060A VALVED CONDUIT. PER MEDICAL RECORDS, PREVIOUS ANNULAR ATTACHMENT DEHISCENCE REPORTED WITH PSEUDOANEURYSM OR ENTIRE AORTIC ROOT COMPLEX. THE PATIENT UNDERWENT REDO AVR WITH PSEUDOANEURYSM REPAIR WITH A 25MM 11060A VALVED AORTIC CONDUIT. THE PATIENT WAS TAKEN TO SICU IN STABLE CONDITION AND DISCHARGED ON POD#9. THIS IS 62-YEAR-OLD MALE PATIENT 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 MEMB

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

  MAUDE report 23679317 ↗
• InjuryNov 25, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 23MM 11060A AORTIC VALVE IN AORTIC POSITION WAS EXPLANTED AND REPLACED WITH A 25MM 11060A KONECT VALVED CONDUIT AFTER AN IMPLANT DURATION OF 1 YEAR, 2 MONTHS AND 2 DAYS. REASON FOR REINTERVENTION WAS NOT 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 23648155 ↗
• InjuryOct 16, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS LEARNED THROUGH MEDICAL RECORDS THAT A PATIENT WITH A 23MM 11060A AORTIC VALVED CONDUIT UNDERWENT PERCUTANEOUS INTERVENTION DUE TO CORONARY OBSTRUCTION. THE PATIENT WAS TAKEN TO THE ICU IN STABLE CONDITION POST PROCEDURE. PER MEDICAL RECORDS, THE PATIENT WAS ASYMPTOMATIC UPON PRESENTATION. TTE ((B)(6) 2025) REVEALED SEVERE BIOPROSTHETIC AORTIC STENOSIS WITH EF OF 55-60%. REDO STERNOTOMY WAS PERFORMED TO EXPLANT THE PREVIOUS 23MM MANGA AORTIC VALVE (B)(4). THE PREVIOUS VALVE WAS EXPLANTED AND THE AREA WAS DEBRIDED. THE SURGEON WENT TO PLACE A 23MM INSPIRIS VALVE BUT FOUND THAT THE LEFT MAIN CORONARY OSTIUM WAS OBSTRUCTED BY THE SEWING RING. THIS PROMPTED THE SURGEON TO REMOVE THE 23MM INSPIRIS AND REPLACE THE AORTIC ROOT WITH A 23MM KONECT VALVED CONDUIT INSTEAD (B)(4). ONCE OFF BYPASS, THERE WAS MILD TO MODERATE RV DYSFUNCTION. PRIOR TO LEAVING THE OR, THE PATIENT DEVELOPED VENTRICULAR FIBRILLATION ON SEVERAL OCCASIONS AND WAS DEFIBRILLATED EACH TIME SUCCESSFULLY. THE SURGEON HAD A CONCERN ABOUT THE INTEGRITY OF THE PATIENT'S RIGHT CORONARY ARTERY. THE PATIENT WAS TAKEN TO THE CATH LAB FOR CARDIAC CATHETERIZATION WHERE THE PATIENT'S RIGHT CORONARY ARTERY WAS STENTED AND FLOW

  Patient problems: Coronary obstruction/occlusion

  MAUDE report 23316351 ↗
• InjuryAug 6, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED VIA IMPLANT PATIENT REGISTRY THAT A 11060A 23MM AORTIC VALVED CONDUIT WAS EXPLANTED AND REPLACED WITH A 11500A 25MM AFTER AN IMPLANT DURATION OF 3 YEARS, 2 MONTHS DUE TO UNKNOWN REASONS. 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 22723897 ↗
• InjuryAug 1, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 23MM 11060A AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 1 YEARS DUE TO UNKNOWN REASON. THE VALVE WAS REPLACED WITH A 23MM 11060A VALVE.

  Patient problems: Insufficient Information

  MAUDE report 22690610 ↗
• InjuryJul 1, 2025Calcified; Mechanical Jam; Calcified; Mechanical Jam

  IT WAS REPORTED AND LEARNED FROM MEDICAL RECORDS, THAT A PATIENT WITH A 23MM 11060A KONECT RESILIA AORTIC VALVED CONDUIT HAS BEEN PLACED UNDER EVALUATION FOR A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 1 YEAR, 6 MONTHS DUE TO SEVERE STENOSIS, MODERATE REGURGITATION AND MODERATE PROSTHETIC LEAFLET RESTRICTION. THE PATIENT PRESENTED WITH NYHA CLASS III.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 22371450 ↗
• InjuryAug 20, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY (IPR). 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. IT WAS REPORTED VIA THE IMPLANT PATIENT REGISTRY THAT THIS VALVED CONDUIT MODEL 11060A23 WAS EXPLANTED FROM THE AORTIC POSITION AFTER AN IMPLANT DURATION OF ONE (1) YEAR AND ELEVEN (11) MONTHS FOR UNKNOWN REASON. A 23MM VALVED CONDUIT WAS IMPLANTED IN REPLACEMENT.

  Patient problems: Insufficient Information

  MAUDE report 20000698 ↗
• InjuryAug 8, 2024Intravalvular regurgitation; Intravalvular regurgitation

  IT WAS REPORTED THAT A 23MM 11060A VALVED CONDUIT IN THE AORTIC POSITION IS UNDER EVALUATION FOR A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 2 YEARS, 10 MONTHS DUE TO INSUFFICIENCY. INTERVENTION HAS NOT BEEN SCHEDULED YET.

  Patient problems: Insufficient Information

  MAUDE report 19940098 ↗
• InjuryMar 28, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  EDWARDS RECEIVED NOTIFICATION THAT A KONECT MODEL 11060A23 WAS EXPLANTED AFTER AN UNKNOWN DURATION DUE TO DEHISCENCE FROM THE ANNULUS OF THE PATIENT. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. ANOTHER KONECT MODEL 11060A SIZE 21 WAS SUCCESSFULLY IMPLANTED IN REPLACEMENT. AS REPORTED, PATIENT HAD SIGNIFICANT BLOOD LOSS, HEART ARRESTED AFTER DECANNULATION AND THE TEAM DECIDED NOT TO RESUSCITATE FURTHER AND PATIENT DIED. THERE WAS NO ALLEGATION THAT THE DEVICE WAS IMPLICATED. THE SURGEON WAS VERY EXPERIENCED WITH KONECT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Insufficient Information

  MAUDE report 18996840 ↗
• InjuryMar 12, 2024Adverse 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 THAT A PATIENT WITH A 23MM 11060A AORTIC VALVED CONDUIT WAS EXPLANTED AFTER AN IMPLANT DURATION OF 1 YEAR DUE TO ENDOCARDITIS. 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: Endocarditis; Insufficient Information

  MAUDE report 18887145 ↗
• InjuryDec 13, 2023Microbial Contamination of Device; Insufficient Device Problem Information; Microbial Contamination of Device; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 23MM 11060A AORTIC VALVE IN AORTIC POSITION WAS EXPLANTED AFTER AN IMPLANT DURATION OF TWO (2) MONTHS, TWENTY-THREE (23) DAYS DUE TO UNKNOWN REASON. THE REPLACEMENT IS ANOTHER 23MM 11060A KONECT RESILIA 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: Endocarditis; Insufficient Information

  MAUDE report 18319632 ↗
• InjuryDec 8, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND MEDICAL RECORD THAT A 23MM 11060A AORTIC VALVED CONDUIT IN AORTIC POSITION WAS EXPLANTED AFTER AN IMPLANT DURATION OF TWO (2) MONTHS, TWENTY-THREE (23) DAYS DUE TO RECURRENT BIOPROSTHETIC ENDOCARDITIS. THE REPLACEMENT IS ANOTHER 23MM 11060A KONECT AVC. THE PATIENT WAS DISCHARGED ON POD #16. PER MEDICAL RECORD: THE PATIENT WAS DISCHARGED AND COMPLETED 6 WEEKS OF ANTIBIOTICS FROM HER INDEX AORTIC VALVED CONDUIT IMPLANT DUE TO ENDOCARDITIS. THE PATIENT PRESENTED TWO (2) MONTHS AND 21 DAYS LATER WITH RIGHT ELBOW PAIN FOR WHICH THERE WAS CONCERN FOR SEPTIC ELBOW, THE CULTURES WERE NEGATIVE, ELBOW PAIN PRESUMED EMBOLIC. A TEE REVEALED A NEW VEGETATION ON THE AORTIC VALVE AND MODERATE MR. THE INDICATION FOR SURGERY RECURRENT ENDOCARDITIS. THE PATIENT UNDERWENT REDO STERNOTOMY, AORTIC ANNULAR RECONSTRUCTION WITH BOVINE PERICARDIUM, AORTIC ROOT REPLACEMENT USING A 23MM 11060A AORTIC VALVE USING A CABROL TECHNIQUE WITH REIMPLANTATION OF THE CORONARIES AND MVR USING A 27MM MITRIS VALVE, AND PACEMAKER GENERATOR AND LEAD REMOVAL. VEGETATIONS ON THE AORTIC VALVE WERE SENT FOR CULTURE. THERE WAS PHLEGMON AROUND THE AORTIC ROOT. THE MITRAL VALVE

  Patient problems: Insufficient Information

  MAUDE report 18291891 ↗
• InjuryNov 19, 2023Calcified; Insufficient Device Problem Information; Calcified; Insufficient Device Problem Information

  IT WAS REPORTED A PATIENT WITH A 25MM 11500A AORTIC VALVE IMPLANTED FOUR (4) YEARS, ONE (1) MONTH, UNDERWENT VALVE-IN-VALVE PROCEDURE DUE TO SEVERE AORTIC INSUFFICIENCY AND MODERATE CALCIFICATION. PATIENT PRESENTED WITH CONGESTIVE HEART FAILURE. TAVR WAS SUCCESSFULLY PERFORMED WITH A 26MM 9755RSL TRANSCATHETER VALVE. PATIENT TOLERATED THE PROCEDURE WELL AND WAS TRANSFERRED TO CCU IN STABLE CONDITION. PATIENT WAS DISCHARGED HOME ON POD # 1.

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

  MAUDE report 18167298 ↗
• InjuryJul 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS LEARNED THROUGH (B)(6) AND MEDICAL RECORDS THAT A PATIENT WITH A 23MM 11060A AORTIC VALVED CONDUIT DEVELOPED THROMBUS ON POD #1. THE PATIENT EXPIRED ON POD #5. PER MEDICAL RECORDS: THE PATIENT PRESENTED APPROXIMATELY TWO (2) YEARS AND FIVE (5) MONTH POST TAVR VALVE WITH AN ACUTE CHF EXACERBATION AND HAD SEVERE RECURRENT AORTIC VALVE REGURGITATION, AND AORTIC STENOSIS. A PREOPERATIVE CATH SHOWED SEVERE PULMONARY HTN WITH PRESSURES 95/35MMHG AND NATIVE MV STENOSIS. PRIOR TO HEART SURGERY THE PATIENT UNDERWENT ID WORKUP, DENTAL EXTRACTIONS AND RENAL FAILURE REQUIRING DIALYSIS. THE 21MM 3300TFX AND NON-EDWARDS TAVR VALVE WERE REMOVED, AND THE PATIENT UNDERWENT ASCENDING AND AORTIC ROOT REPLACEMENT WITH A 23MM 11060A AORTIC VALVED CONDUIT WITH REIMPLANTATION OF THE CORONARIES AND CABG X2. IT IS NOTED THERE WAS SEVERE PROSTHETIC LEAFLET DEGENERATION/DESTRUCTION, POSSIBLY SUGGESTIVE OF PRIOR SUB ENDOCARDITIS. IT IS NOTED DUE TO THE LONG DURATION OF CPB, THE PATIENT WAS LEFT ON CENTRAL VA ECMO WITH AN OPEN CHEST. ON POD # 1 THE PATIENT RETURNED TO OR IN NEED OF WASHOUT, THE TEE SHOWED SIGNIFICANT THROMBUS ATTACHED TO THE VALVE AND OBSTRUCTING THE LVOT AND AT RISK OF EMBOLIZATION. TH

  Patient problems: Thrombosis/Thrombus

  MAUDE report 17394202 ↗
• InjuryMar 10, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 23MM 11060A VALVE IN THE AORTIC POSITION UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 2 MONTHS DUE TO UNKNOWN REASON. THE PROCEDURE WAS PERFORMED WITH A 23MM 9750TFX TRANSCATHETER VALVE. THE PATIENT POST-PROCEDURE STATUS IN RECOVERY. 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 16527083 ↗
• InjuryMar 10, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THAT A PATIENT WITH A 23MM 11060A AORTIC VALVE WAS EXPLANTED SAME DATE OF SURGERY LATER THAT NIGHT DUE TO UNKNOWN REASONS. REPLACEMENT VALVE IS UNKNOWN .

  Patient problems: Insufficient Information

  MAUDE report 16526309 ↗
• InjuryDec 13, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS LEARNED THROUGH THE IMPLANT REGISTRY THAT THE GRAFT PART ONLY OF A 23MM 11060A AORTIC VALVED CONDUIT WAS IMPLANTED. POST OPERATIVELY THE PATIENT UNDERWENT EMERGENCY MEDIASTINAL EXPLORATION FOR BLEEDING. PER MEDICAL RECORDS THIS CASE INVOLVED A 43-YEAR-OLD MALE PATIENT WITH A HISTORY OF MARIJUANA USE. THE PATIENT WAS ADMITTED WITH A TYPE A FOCAL IN THE ASCENDING AORTA WITH ANEURYSMAL PROXIMAL ASCENDING AORTA WITH EVIDENCE OF INTRAMURAL VERSUS SUBEPICARDIAL HEMATOMA AND MODERATE TO SEVERE NATIVE AORTIC INSUFFICIENCY. THE PATIENT HAD ALTERED LOC, DRUG SCREEN WAS POSITIVE FOR COCAINE. THE PATIENT UNDERWENT EMERGENCY SURGERY. THE PATIENT UNDERWENT AVR AND REPLACEMENT OF THE ASCENDING AORTA THE AORTIC VALVE WAS REPLACED WITH A 23MM 11500A AORTIC VALVE. IT IS NOTED BOTH CORONARY OSTIA WERE VISUALIZED AND WERE UNOBSTRUCTED. THE 26MM DACRON GRAFT WAS PREPARED AND TAILORED APPROPRIATELY FOR THE DISTAL ANASTOMOSIS. THE PROXIMAL PORTION OF THE GRAFT WAS TAILORED APPROPRIATELY, AND THE PROXIMAL ANASTOMOSIS FASHIONED WITH CONTINUOUS 3-0 PROLENE. IT IS NOTED ALONG THE ROOT THERE WAS A FOCAL DEFECT IN THE AORTA JUST DISTAL TO THE STJ ABOVE THE COMMISSURE OF THE LEFT AND RIGHT CORONARY CUSPS

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15966079 ↗
• InjuryOct 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS LEARNED THROUGH MEDICAL RECORDS THAT A 23MM 11060A AORTIC VALVED CONDUIT WAS IMPLANTED AND BLEEDING WAS OBSERVED AFTER DE-CANNULATION WHILST STILL IN OR. THE BLEEDING WAS IDENTIFIED TO ORIGINATE IN THE BASE OF THE VALVE CONDUIT AT THE LEVEL OF THE LEFT VENTRICULAR OUTFLOW TRACT. THIS AREA IS VERY DIFFICULT TO ASSESS THEREFORE THE PATIENT WAS RECANNULATED. CPB WAS RESUMED. THE BLEEDING AREA AT THE ANASTOMOSIS BETWEEN THE VENTRICLE AND THE AORTIC VALVE CONDUIT WAS REPAIRED. A POST IMPLANT TEE SHOWED WELL PRESERVED LV AND RV FUNCTION AND THE AORTIC VALVE APPEARED TO BE FUNCTIONING NORMALLY . THE PATIENT WAS TRANSFERRED TO THE ICU IN STABLE CONDITION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15522769 ↗
• InjuryAug 15, 2022Detachment of Device or Device Component; Insufficient Device Problem Information; Detachment of Device or Device Component; Insufficient Device Problem Information

  IT WAS REPORTED THAT A 23MM 11060A VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 1 DAY DUE TO UNKNOWN REASON. THE EXPLANTED VALVE WAS REPLACED WITH A 23MM 11060A VALVE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Insufficient Information

  MAUDE report 15230471 ↗
• InjuryMar 3, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  EDWARDS IMPLANT PATIENT REGISTRY RECEIVED INFORMATION 23MM 11060A VALVED CONDUIT WAS EXPLANTED AFTER EIGHT (8) MONTHS DUE TO UNKNOWN REASONS. THE EXPLANTED DEVICE WAS REPLACED WITH A 21MM 11060A VALVED CONDUIT. CONCOMITANT CORONARY ARTERY BYPASS WAS PERFORMED. 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 13664344 ↗
• DeathSep 17, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED AND DISCOVERED THROUGH MEDICAL RECORDS THAT A PATIENT WITH A 23MM 11060A AORTIC VALVED CONDUIT IMPLANTED FOR ONE (1) MONTH 8 DAYS WAS EXPLANTED DUE TO DEHISCENCE AND BLEEDING AT THE AT PROXIMAL ANASTOMOSIS. THE PATIENT PRESENTED WITH CHEST PAIN AND PERICARDIAL TAMPONADE. THE INDICATION FOR THE INDEX PROCEDURE WAS A TYPE A THORACOABDOMINAL DISSECTION. A 25MM 11500A AORTIC VALVE SEWN INTO A NON EDWARD GRAFT, AND THE PULMONARY ARTERY TEAR CAUSED BY DEHISCENCE WAS REPAIRED SUCCESSFULLY. THE VALVE WAS WELL FUNCTIONING. THE PATIENT WAS RETURNED TO THE ICU IN CRITICAL CONDITION, BUT STABLE CONDITION. THE POST OPERATIVE COURSE WAS COMPLICATED BY: HIT, MULTIPLE ORGAN FAILURE, SEPSIS RENAL FAILURE; RESPIRATORY FAILURE; PNEUMONIA, ATRIAL FIBRILLATION, AND ISCHEMIC STROKE, THE PATIENT WAS PLACED ON COMFORT CARE, AND EXPIRED ON POD#35. THE PRELIMINARY CAUSE OF DEATH WAS DENOTED AS PNEUMONIA; MULTIPLE ORGAN FAILURE CONTRIBUTED TO THE DEATH. PER PHYSICIAN NO ALLEGATION OF DEVICE MALFUNCTION OR PRODUCT DEFICIENCY OF THE EXPLANTED VALVE. EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR SERIALIZED EDWARDS IMPLANTABLE DEVICE

  Patient problems: Cardiac Tamponade; Hemorrhage/Blood Loss/Bleeding; Laceration(s)

  MAUDE report 12492928 ↗