KONECT RESILIA 11060A (REF 11060A25)Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00690103193855), received between Jan 28, 2022 and Jun 18, 2026 — classified as 22 injuries, 1 malfunction.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjuryJun 18, 2026Insufficient Device Problem Information

  IT WAS REPORTED VIA THE IMPLANT PATIENT REGISTRY THAT A 11060A 25MM AORTIC VALVED CONDUIT WAS EXPLANTED AND REPLACED WITH A 11060A 25MM AFTER AN IMPLANT DURATION OF 3 YEARS, 4 MONTHS DUE TO UNKNOWN REASONS. THE PATIENT WAS ALIVE. 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 25552819 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AND LEARNED THROUGH MEDICAL RECORDS THAT A PATIENT WITH A 25MM 11060A AORTIC VALVED CONDUIT WAS EXPLANTED AT IMPLANT DUE TO BLEEDING. THE EXPLANTED DEVICE WAS REPLACED WITH AN UNKNOWN DEVICE. THE PATIENT INITIALLY WAS TAKEN TO THE OR TO TREAT ACUTE TYPE A AORTIC DISSECTION. THE NATIVE AORTIC VALVE WAS REPLACED WITH A 25 MM 11060A VALVED CONDUIT THAT WAS SEATED AND SECURED WITH COR-KNOT. AFTER THE PATIENT WAS WEANED FROM BYPASS AND DECANNULATED, THERE WAS HIGH VOLUME ARTERIAL BLEEDING FROM NEAR THE AORTIC ROOT. THE PATIENT WENT BACK ON BYPASS, AND THE TEAM WAS NOT ABLE TO VISUALIZE THE SOURCE OF BLEEDING. IT WAS DECIDED TO REARREST THE HEART AND TOOK THE ROOT APART AND THE TIP OF A COR-KNOT WAS VISIBLE NEAR THE LEFT MAIN. THE VALVED CONDUIT, COR-KNOT AND PLEDGETS WERE REMOVED AND ANOTHER DEVICE WAS PLACED IN REPLACEMENT HAND TIED RATHER THAN USING COR-KNOT. THE PATIENT CAME OFF BYPASS, AND THE BLEEDING SITE WAS FIXED, HOWEVER; THERE WAS TORRENTIAL COAGULOPATHIC BLEEDING FROM ALL SITES. THE TEAM SPENT SEVERAL HOURS PACKING AND DRYING UP AND THE PATIENT RETURNED TO THE ICU IN CRITICAL CONDITION. RESUSCITATION ATTEMPTS WERE PERFORMED IN THE OR AND ICU, HOWEVER, THE PATI

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24735848 ↗
• InjuryFeb 17, 2026Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND MEDICAL RECORDS THAT A PATIENT WITH A 25MM 11060A KONECT RESILIA AORTIC VALVED CONDUIT WAS EXPLANTED AFTER AN IMPLANT DURATION OF 1 YEAR, 3 MONTHS DUE TO AORTIC ROOT PSEUDOANEURYSM. THE PATIENT PRESENTED WITH CHEST PAIN. THE EXPLANTED VALVE WAS REPLACED WITH A 23MM 11060A VALVED CONDUIT. THE PATIENT WAS TRANSFERRED TO THE CICU IN CRITICAL, BUT STABLE CONDITION. THE PATIENT WAS DISCHARGED POD #7. PER MEDICAL RECORDS, THE PATIENT IS A KNOWN CASE OF LOEYS-DIETZ SYNDROME WHO PRESENTED WITH CHEST PAIN. BLOOD CULTURE WAS POSITIVE FOR MSSA BACTEREMIA. TEE (09/18/25) REVEALED RECURRENT SCENDING AORTA AND AORTIC ROOT PSEUDOANEURYSM IN ADDITION TO ABSCESS NEAR AORTIC GRAFT. REDO STERNOTOMY WAS PERFORMED TO REPLACE THE PATIENT'S PREVIOUS 25MM RESILIA WITH A 23MM RESILIA. INTRA-OPERATIVELY, THE PATIENT WAS FOUND TO HAVE TWO ACTIVE BLEEDING SITES (PSEUDOANEURYSM) WITH NO OBVIOUS SIGN OF INFECTION. THE 23MM 11060A KONECT RESILIA AORTIC VALVED CONDUIT WAS IMPLANTED SUCCESSFULLY AND THE PATIENT TOLERATED THE PROCEDURE WELL. THE PATIENT WAS TRANSFERRED TO THE CICU IN CRITICAL, BUT STABLE CONDITION. THE PATIENT WAS DISCHARGED POD #7. PER PATHOLOGY

  Patient problems: Insufficient Information

  MAUDE report 24371080 ↗
• InjuryDec 31, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED AND LEARNED THROUGH MEDICAL RECORDS THAT A 25MM 11060A AORTIC VALVED CONDUIT WAS EXPLANTED AT IMPLANT DUE TO BLEEDING. THE EXPLANTED DEVICE WAS REPLACED WITH A 23MM 11060A AORTIC VALVED CONDUIT. THE PATIENT WAS IN RECOVERY POST PROCEDURE. PER MEDICAL RECORDS, PATIENT UNDERWENT AORTIC DISSECTION REPAIR. INTRAOPERATIVELY, NATIVE AORTIC VALVE LEAFLETS WERE DEBRIDED SHARPLY AND A 25MM 11060A VALVED CONDUIT WAS SEATED INTO PLACE WITH CORONARY BUTTON REIMPLANTATION. FOLLOWING CROSS-CLAMP REMOVAL, SIGNIFICANT BLEEDING WAS NOTED FROM THE LEFT AND RIGHT CORONARY OSTIUM SITE. THE HEART WAS REARRESTED AND BOTH CORONARY OSTIA WERE TIGHTENED. HOWEVER, THERE WAS STILL BLEEDING, WITH ST CHANGES CORRESPONDING TO THE RCA TERRITORY. THE SURGEON DECIDED TO GRAFT THE RCA, RESOLVING THE ST CHANGES. HOWEVER, BLEEDING WAS STILL NOTED. THE 11060A VALVE WAS REMOVED AND REPLACED WITH A SMALLER VALVED CONDUIT. THE RIGHT CORONARY OSTIUM WAS NOTED TO BE IN POOR CONDITION. FOLLOWING CROSS-CLAMP REMOVAL, BLEEDING WAS NOTED TO BE MUCH BETTER. PATIENT WAS LEFT WITH CHEST OPEN DUE TO COAGULOPATHY ISSUES. PATIENT TOLERATED THE PROCEDURE AND WAS TRANSFERRED TO ICU IN STABLE CONDITION. THE PATIENT WAS

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23936505 ↗
• InjuryNov 12, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 25MM 11060A AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 1 YEAR, 9 MONTHS DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH A 25MM 11060A 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 23535607 ↗
• InjuryOct 31, 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 THAT A PATIENT WITH A 25 MM 11060A AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 2 YEARS, 10 MONTHS DUE TO UNKNOWN REASON. THE EXPLANTED VALVE WAS REPLACED WITH A 25 MM 11060A 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 23437631 ↗
• MalfunctionJul 3, 2025Fluid/Blood Leak; Fluid/Blood Leak

  PER THE REPORT RECEIVED FORM INDIA, EDWARDS WAS NOTIFIED OF AN EVENT DESCRIBING A BLEEDING FROM GRAFT ISSUE DURING IMPLANTATION OF A KONECT RESILIA AORTIC VALVED CONDUIT MODEL 11060A25. AS REPORTED, POST-ANASTOMOSIS, THERE WAS A PERSISTENT BLEEDING OBSERVED THAT SEEMED TO COME FROM THE AORTIC ROOT AND THE ANNULUS. HOWEVER, AFTER APPROXIMATELY TWO (2) HOURS OF EVALUATION, THE BLEEDING SOURCE DID NOT STOP AFTER PROTAMINE ADMINISTRATION AND WAS IDENTIFIED TO BE COMING FROM THE GRAFT. AS REPORTED, THE GRAFT HAD BEEN PREVIOUSLY RINSED AS PER IFU PRIOR TO IMPLANTATION AND NO DEAIRING NEEDLE WAS INSERTED IN THIS CASE (THE HOLE IN THE TOP END OF THE VEIN WAS USED TO DEAIR). REPORTEDLY, THE BLEEDING WAS DETECTED TO BE COMING FROM A SINGLE HOLE AREA OF 1.5X0.5CM AND IT WAS ARRESTED AND MANAGED WITH A SUTURE, REPLACING THE DAMAGED AREA. IT WAS FURTHER REPORTED AFTER FOLLOW-UP THAT ADDITIONAL MEASURES WERE REQUIRED INCLUDING THREE (3) EXTRA UNITS OF WHOLE BLOOD, ONE (1) UNIT OF SINGLE-DONOR PLATELETS AND TWO (2) UNITS OF CLOTTING FACTORS [OCTUPLEX]. THE PATIENT WAS REPORTED TO BE STABLE AFTER THE PROCEDURE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22396205 ↗
• InjuryMay 30, 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 11060A AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 4 YEARS, 7 MONTHS DUE TO ENDOCARDITIS. THE EXPLANTED VALVE WAS REPLACED WITH A 23MM 11060A VALVE. THE PATIENT WAS IN RECOVERY POST PROCEDURE. THE PATIENT WAS DISCHARGED TO CARE CENTER ON POD#13. PER MEDICAL RECORDS, THE PATIENT PRESENTED WITH FEVER AND SOB FOR 3 WEEKS. BLOOD CULTURES SHOW POSITIVE FOR MRSA AND TEE ON (B)(6) 2025 SHOWED ECHO DENSITIES CONSISTENT WITH AV VEGETATION AND AORTIC GRAFT AND ROOT ABSCESS. THE PATIENT WAS STARTED ON IV ANTIBIOTICS. THE PATIENT UNDERWENT REDO-AVR WITH 21MM KONECT AVC. POSTOPERATIVE TEE ON POD#9 SHOWED NEW AVC APPEARS WELL-SEATED WITH NO REGURGITATION AND NO STENOSIS. POSTOPERATIVELY, THE PATIENT NEEDED A NEW PACEMAKER ((B)(6) 2025).

  Patient problems: Endocarditis; Insufficient Information

  MAUDE report 22115994 ↗
• InjuryMay 13, 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 11060A AORTIC VALVED CONDUIT (AVC) WAS EXPLANTED AFTER AN IMPLANT DURATION OF 9 MONTHS DUE TO STAPHYLOCOCCUS EPIDERMIDIS ENDOCARDITIS. THE DEVICE WAS REPLACED WITH A 23MM 11060A AVC. PER MEDICAL RECORDS, THE PATIENT PRESENTED WITH CHEST SWELLING AND REDNESS. CT CHEST SHOWED FLUID COLLECTION AND SMALL PSEUDOANEURYSM OF AORTIC ROOT GRAFT, BLOOD CULTURES + FOR MRSE BACTEREMIA. HE WAS TAKEN URGENTLY TO OR FOR ENDOCARDITIS AND REDO AVC. INTRAOPERATIVE FINDINGS SHOWED PERI-ANNULAR ABSCESS/DEHISCENCE OF THE AORTIC ROOT CONDUIT WITH VEGETATION ON THE AORTIC LEAFLETS. THE AVC WAS RESECTED FROM THE ANNULUS, AND A 23MM AVC WAS IMPLANTED AND SECURED WITH SUTURES MANUALLY TIED. TEE SHOWED THE NEW VALVE WAS FUNCTIONING PROPERLY WITHOUT LEAK. THE PATIENT TRANSFERRED TO THE ICU IN CRITICAL BUT STABLE CONDITION AND DISCHARGED ON POD #9.

  Patient problems: Endocarditis; Insufficient Information

  MAUDE report 22014102 ↗
• InjuryMar 25, 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 11060A AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 2 YEARS, 6 MONTHS DUE ENDOCARDITIS (ENTEROCOCCUS). THE EXPLANTED VALVE WAS REPLACED WITH A 23MM 11060A VALVE. THE PATIENT WAS IN RECOVERY POST PROCEDURE. PER MEDICAL RECORDS, TEE POST PROCEDURE SHOWED PROSTHETIC VALVE IN WELL SEATED IN GOOD POSITION, AND NO PARAVALVULAR LEAK.

  Patient problems: Endocarditis; Insufficient Information

  MAUDE report 21693953 ↗
• InjuryFeb 7, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED VIA THE PATIENT REGISTRY THAT A PATIENT WITH A 25MM 11060A AORTIC VALVED CONDUIT UNDERWENT REDO AORTIC VALVE REPLACEMENT AFTER AN IMPLANT DURATION OF FOUR (4) YEARS, TWO (2) MONTHS DUE TO UNKNOWN REASONS. THE EXPLANTED DEVICE 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 21330326 ↗
• InjurySep 13, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THROUGH IMPLANT PATIENT REGISTRY IT WAS LEARNED A 25MM 11060A AORTIC VALVED CONDUIT IMPLANTED ONE (1) YEARS, FOUR (4) MONTHS, WAS EXPLANTED DUE TO UNKNOWN REASONS. THE EXPLANTED DEVICE WAS REPLACED WITH A 23MM 11060A AORTIC VALVED CONDUIT. PATIENT POST-OPERATIVE STATUS NOTED AS IN RECOVERY. EXPLANT WAS NOT DUE TO DEFICIENCY IN THE ORIGINAL DEVICE. 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 20217113 ↗
• InjuryMay 16, 2024Calcified; Difficult to Open or Close; Calcified; Difficult to Open or Close

  IT WAS REPORTED A PATIENT WITH A 25MM 11060A AORTIC VALVED CONDUIT IMPLANTED TWO (2) YEARS, SIX (6) MONTHS, UNDERWENT VALVE-IN-VALVE PROCEDURE DUE TO SEVERE BIOPROSTHETIC AORTIC VALVE STENOSIS AND MOTION RESTRICTED LEAFLETS. TAVR WAS SUCCESSFULLY PERFORMED WITH A 26MM 9755RSL TRANSCATHETER VALVE. PATIENT WAS TRANSFERRED TO ICU. PER MEDICAL RECORDS, PATIENT PRESENTED WITH CHEST PAIN. TEE DEMONSTRATED SEVERE AORTIC STENOSIS AND SEVERE LEAFLET RESTRICTION WITH ONLY MINIMAL MOBILITY IN THE ANTERIOR MOST LEAFLET VISUALIZED. IABP SUPPORTED TAVR WAS SUCCESSFULLY PERFORMED WITH A 26MM 9755RSL TRANSCATHETER VALVE. PATIENT WAS TRANSFERRED TO ICU.

  Patient problems: Chest Pain; Heart Failure/Congestive Heart Failure

  MAUDE report 19332401 ↗
• InjuryApr 29, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THROUGH IMPLANT PATIENT REGISTRY IT WAS LEARNED A 25MM 11060A AORTIC VALVED CONDUIT WAS EXPLANTED SAME DAY DUE TO UNKNOWN REASONS. THE EXPLANTED DEVICE WAS REPLACED WITH ANOTHER 25MM 11060A AORTIC VALVED CONDUIT. PATIENT POST-OPERATIVE STATUS NOTED AS 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 19210116 ↗
• InjuryApr 24, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED VIA THE PATIENT REGISTRY THAT A PATIENT WITH A 25MM 11060A AORTIC VALVED CONDUIT UNDERWENT A REDO AORTIC VALVE REPLACEMENT PROCEDURE AFTER AN IMPLANT DURATION OF ONE (1) YEAR, THREE (3) MONTHS DUE TO UNKNOWN REASONS. THE EXPLANTED DEVICE WAS REPLACED WITH ANOTHER 25MM 11060A AORTIC VALVED CONDUIT.

  Patient problems: Insufficient Information

  MAUDE report 19175173 ↗
• InjuryMar 7, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 25MM 11060A AORTIC VALVED CONDUIT, IN AORTIC POSITION WAS EXPLANTED AND REPLACED WITH ANOTHER 25MM 11060A AORTIC VALVE AFTER AN IMPLANT DURATION OF ONE (1) YEAR, 3 MONTHS, AND 14 DAYS 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 18862462 ↗
• InjuryMar 4, 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 A VALVE MODEL 11060A25 IMPLANTED IN AORTIC POSITION WAS EXPLANTED FROM A 50-YEAR-OLD PATIENT AFTER AN IMPLANT DURATION OF TEN (10) MONTHS AND SEVEN (7) DAYS FOR UNKNOWN REASON. A VALVE MODEL 11060A23 WAS IMPLANTED IN REPLACEMENT. CONCOMITANT CORONARY ARTERY BYPASS WAS PERFORMED. AS PER THE IMPLANT DATA CARD (IDC) RECEIVED, PATIENT WAS IN RECOVERY AFTER THE PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 18825021 ↗
• InjuryDec 12, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 25MM 11060A AORTIC VALVED CONDUIT WAS EXPLANTED AFTER AN IMPLANT DURATION OF 2 YEARS, 9 MONTHS DUE TO UNKNOWN REASON. 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 18312998 ↗
• InjuryNov 7, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED VIA IMPLANT PATIENT REGISTRY THAT A 11060A 25MM AORTIC VALVED CONDUIT WAS EXPLANTED AND REPLACED WITH A 11060A 23MM AFTER AN IMPLANT DURATION OF 4 MONTHS DUE TO ENDOCARDITIS, SEVERE STENOSIS, AND MOTION RESTRICTED. PER MEDICAL RECORDS THE PATIENT PRESENTED WITH SYNCOPE AND HYPOTENSION. THE CULTURE GREW CANDIDA PARAPSILOSIS. THE PATIENT UNDERWENT REDO-STERNOTOMY, BENTALL, AND RE-REPLACEMENT OF ASCENDING AORTIC ANEURYSM. THE PATIENT WAS WEANED OFF WITHOUT DIFFICULTY AND TAKEN TO ICU FOR RECOVERY.

  Patient problems: Insufficient Information

  MAUDE report 18086178 ↗
• InjurySep 24, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED FROM IMPLANT PATIENT REGISTRY THAT A 25MM AORTIC VALVED CONDUIT WAS EXPLANTED AND REPLACED WITH A 25MM AORTIC VALVED CONDUIT AFTER AN IMPLANT DURATION OF 11 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 15476055 ↗
• InjuryAug 16, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS LEARNED VIA THE PATIENT REGISTRY THAT A PATIENT WITH A 25MM 11060A AORTIC VALVED CONDUIT UNDERWENT A REDO AORTIC VALVE REPLACEMENT PROCEDURE AFTER AN IMPLANT DURATION OF 2 (TWO) MONTHS, 22 DAYS DUE TO A MASSIVE PSEUDOANEURYSM OF THE AORTIC ARCH WHICH DEVELOPED A LARGE LEAK OF FLUID FROM THE ARCH. ECHO DEMONSTRATED A SEVERE AORTIC INSUFFICIENCY. THE PATIENT EXHIBITED A TYPE A AND B AORTIC DISSECTION AND PRESENTED WITH SHORTNESS OF BREATH. THE VALVE WAS EXPLANTED AND REPLACED WITH ANOTHER 25MM 11060A VALVED CONDUIT. THERE WAS DIFFICULTY SEPARATING THE PATIENT FROM BYPASS DUE TO POOR LV CONTRACTILITY AND HYPOTENSION. CPB WAS CONVERTED TO VA ECMO. THE PATIENT WAS TRANSFERRED TO THE ICU POST PROCEDURE WITHOUT COMPLICATIONS IN STABLE CONDITION. ON POD #0 THE PATIENT RETURNED TO THE OPERATING ROOM FOR POST-OP BLEEDING AND WAS FOUND TO HAVE A HOLE IN THE RIGHT ATRIUM WHICH WAS REPAIRED WITH A SMALL PATCH. THE PROCEDURE WAS TOLERATED WELL AND THE PATIENT WAS TRANSFERRED TO BACK TO THE ICU. ON POD #11 THE PATIENT WAS TRANSFERRED TO CT SURGERY STEPDOWN TELEMETRY UNIT. THE PATIENT WAS DISCHARGED HOME ON POD #19 IN STABLE CONDITION. CONCOMITANT REDO CABG PROCEDURE WAS PERFORMED.

  Patient problems: Dyspnea; Vascular Dissection

  MAUDE report 15234388 ↗
• InjuryMay 10, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A 25MM VALVED CONDUIT WAS EXPLANTED AT IMPLANT AND REPLACED WITH A 11060A 23MM DUE TO OVERSIZE ISSUE. THE PATIENT WAS RECOVERING. AS REPORTED, THE ANNULAR TISSUE BELOW THE 25MM VALVED CONDUIT WAS FRIABLE AND TORN WITH THE VALVE SUTURE PLACEMENT. THE PATIENT EXPERIENCED BLEEDING. THE AREA WAS REPAIRED WITH A PERICARDIAL PATCH AND A 23MM VALVED CONDUIT WAS IMPLANTED. PER SURGEON THE 25MM VALVED CONDUIT WAS FINE.

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

  MAUDE report 14347511 ↗
• InjuryJan 28, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THROUGH THE IMPLANT PATIENT REGISTRY, IT WAS LEARNED THAT A PATIENT WITH 27MM 11060A AORTIC VALVE, IMPLANTED FOR ONE DAY, WAS EXPLANTED DUE TO UNKNOWN REASONS. THE EXPLANTED DEVICE WAS REPLACED WITH A 25MM 11060A VALVE. PER THE MEDICAL RECORDS, THE PATIENT PRESENTED WITH PNEUMONIA, TYPE A AORTIC DISSECTION, AND AORTIC ROOT ANEURYSM. THE PATIENT UNDERWENT URGENT REPAIR OF A TYPE A AORTIC DISSECTION WITH ASCENDING TO HEMI ARCH REPLACEMENT WITH A 28MM GRAFT, AORTIC ROOT REPLACEMENT WITH A 27MM 11060A KONECT AORTIC VALVED CONDUIT AND CABG X1. INTRAOPERATIVELY, AFTER SIZING THE AORTIC ROOT, HORIZONTAL PLEDGETED SUTURES WERE PLACED FROM OUTSIDE OF THE AORTA TO THE INSIDE THE ANNULUS AS THE AORTIC ROOT TISSUE WAS FRIABLE. THE AORTIC ROOT WAS BIG AND 27MM SIZER WENT THROUGH EASILY. A 27MM 11060A KONECT RESILIA AORTIC VALVED CONDUIT WAS USED. THE ANNULAR SUTURES WERE PASSING THROUGH THE CUFF OF VALVED CONDUIT. THE CONDUIT WAS LOWERED INTO THE ANNULUS AND ALL OF THE SUTURES WERE TIED DOWN. A RUNNING SUTURE BETWEEN THE CUT EDGE OF THE AORTIC WALL AND THE CUFF OF THE VALVED CONDUIT WAS PLACED TO ACHIEVE HEMOSTASIS. THE LEFT CORONARY BUTTON WAS ANASTOMOSED TO THE VALVED CONDUIT. NEXT, THIS VALV

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

  MAUDE report 13387483 ↗