KONECT RESILIA 11060A (REF 11060A27)Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00690103201390), received between Mar 24, 2022 and May 20, 2026 — classified as 28 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (22 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 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• InjuryMay 20, 2026Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND MEDICAL RECORDS THAT A PATIENT WITH A 27MM 11060A AORTIC VALVED CONDUIT WAS EXPLANTED AFTER AN IMPLANT DURATION OF 1 DAY DUE TO UNKNOWN REASON. THE PROVIDED MEDICAL RECORDS DID NOT MENTION THE 27MM 11060A AORTIC VALVED CONDUIT. PER MEDICAL RECORDS, THE PATIENT PRESENTED WITH RIGHT JAW PAIN, CHEST PAIN, AND BLE WEAKNESS. THE PATIENT WAS FOUND TO HAVE CT EVIDENCE OF A TYPE A AORTIC DISSECTION. REDO STERNOTOMY WAS PERFORMED FOR THE AORTIC DISSECTION REPAIR AND AORTIC VALVE REPLACEMENT WITH A 25MM KONECT VALVED CONDUIT. INTRA-OPERATIVELY, ONCE THE AORTA WAS UNCLAMPED, THE PATIENT EXPERIENCED V-FIB REQUIRING INTERNAL DEFIB X6. INTRA-OP TEE NOTED A DILATED LV WITH NORMAL BIVENTRICULAR FUNCTION. THE 25MM KONECT VALVED CONDUIT WAS IMPLANTED SUCCESSFULLY WITHOUT COMPLICATION. THE PATIENT WAS TAKEN TO THE ICU POST PROCEDURE. THE PATIENT WAS DISCHARGED POD #4. 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

  Patient problems: Insufficient Information

  MAUDE report 25235535 ↗
• InjuryMar 31, 2026Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A 27MM 11060A AORTIC VALVED CONDUIT WAS EXPLANTED AFTER AN IMPLANT DURATION OF 2 YEARS DUE TO CUTIBACTERIUM ACNES ENDOCARDITIS OF THE AVC GRAFT. THE EXPLANTED DEVICE WAS REPLACED WITH ANOTHER 27MM 11060A AORTIC VALVED CONDUIT. PER MEDICAL RECORDS, THE PATIENT PRESENTED IN ER WITH WORSENING FATIGUE AND HYPOTENSION. ECHO SHOWED 27MM AVC WITH NORMAL STRUCTURE AND FUNCTION, MG 8MMHG AND NO PVL. CHEST CT REVEALED PERIAORTIC SEROMA/ABSCESS. THE PATIENT UNDERWENT REDO AVR AND BENTALL PROCEDURE. INTRAOP, SUBSTERNAL POCKET OF THICK WHITE CREAMY PUS WAS ENCOUNTERED, NO ABSCESS IN THE ANNULAR AREA, CULTURES WERE SENT. DRAINAGE OF ABSCESSES PERI-GRAFT AND BELOW XIPHOID. AFTER COPIOUS IRRIGATION/DEBRIDEMENT ANOTHER 27MM AVC WAS IMPLANTED WITH MATTRESS PLEDGETED SUTURES AND SECURED WITH COR-KNOTS. THERE WAS EXCELLENT FUNCTION OF THE VALVE. IT WAS NOTED THERE WAS NO FREE FLUID COMING FROM THE DEPTH OF THE DISSECTION, SUGGESTING A POTENTIAL LYMPHATIC LEAK/LYMPHOCELE. WHILE WEANING FROM CPB, PROFOUND VASOPLEGIA, COAGULOPATHY, AND MODERATE RV DYSFUNCTION. AFTER LONG PERIOD OF HEMOSTASIS, THE PATIENT WAS TAKEN TO ICU IN GOOD CONDI

  Patient problems: Insufficient Information

  MAUDE report 24746464 ↗
• InjuryMar 6, 2026Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 27MM 11060A AORTIC VALVED CONDUIT WAS EXPLANTED AFTER AN IMPLANT DURATION OF 1 YEAR AND 11 MONTHS DUE TO UNKNOWN REASON. THE VALVE WAS REPLACED WITH A 27MM 11500A BIOPROSTHETIC VALVE.

  Patient problems: Insufficient Information

  MAUDE report 24539303 ↗
• InjuryMar 6, 2026Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 27MM 11060A AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 1 YEARS, 8 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 24531041 ↗
• InjuryFeb 18, 2026Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 27MM 11060A AORTIC VALVED CONDUIT WAS EXPLANTED AFTER AN IMPLANT DURATION OF 2 YEARS, 2 MONTHS DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH A 25MM 11060A 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: Insufficient Information

  MAUDE report 24380105 ↗
• InjuryJan 13, 2026Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 27MM 11060A AORTIC VALVED CONDUIT WAS EXPLANTED AFTER AN IMPLANT DURATION OF 11 MONTHS DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH A 25MM 11060A 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: Insufficient Information

  MAUDE report 24056711 ↗
• MalfunctionDec 10, 2025Incomplete Coaptation; Incomplete Coaptation

  PER MEDICAL RECORDS, THE PATIENT WAS DIAGNOSED WITH SEVERELY CALCIFIED BICUSPID AORTIC VALVE WITH SEVERE STENOSIS AND MILD INSUFFICIENCY. THE PATIENT INITIALLY UNDERWENT AORTIC AND ASCENDING AORTIC REPLACEMENT WITH A 27MM KONECT VALVED CONDUIT COMPOSITE VALVE GRAFT, AND LAA CLIPPING. THE 27MM KONECT SEATED WITH NO ISSUES. A HOLE WAS MADE IN THE POSTERIOR PORTION OF THE GRAFT. REIMPLANTATION OF THE CORONARY ARTERIES WERE PERFORMED. CROSS-CLAMP WAS REMOVED. TEE SHOWED MODERATE TO SEVERE CENTRAL REGURGITATION. IT APPEARED TO ORIGINATE FROM THE CENTER OF THE VALVE AND EXTENDED ALONG THE COAPTATION BETWEEN THE NONCORONARY CUSP AND LEFT CORONARY CUSP. CROSSCLAMP WAS PLACED AGAIN. THERE WERE NO SUTURES OR CALCIFICATIONS ALONG THE ANNULUS THAT WERE IMPINGING THE VALVE AND NO BIOGLUE NOTED. THE NONCORONARY LEAFLET APPEARED TO BE TIGHT WITH A FOLD WITHIN THE LEAFLET. IT DID NOT COAPT WELL WITH THE OTHER TWO LEAFLETS. THE VALVE PORTION OF THE COMPOSITE GRAFT WAS CAREFULLY REMOVED. THE METAL AND PLASTIC PORTIONS OF THE VALVE WERE REMOVED, AND THE GRAFT ITSELF WAS LEFT IN PLACE. LARGE BITES WITH LARGE NEEDLES WERE PLACED USING PLEDGETED HORIZONTAL MATTRESS SUTURES AROUND THE ANNULUS. A 25MM INS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23770146 ↗
• InjuryOct 30, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 27MM 11060A AORTIC VALVED CONDUIT WAS EXPLANTED AFTER AN IMPLANT DURATION OF 1 YEAR, 9 MONTHS DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH A 27MM 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 23427455 ↗
• InjuryOct 15, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT WITH A 27MM 11060A AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 4 YEARS, 3 MONTHS DUE TO UNKNOWN REASONS. THE PROCEDURE WAS PERFORMED WITH A 26MM 9755RSL TRANSCATHETER VALVE.

  Patient problems: Insufficient Information

  MAUDE report 23282330 ↗
• InjurySep 15, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS LEARNED FROM A RETROSPECTIVE CLINICAL TRIAL THAT A PATIENT WITH A 27MM 11060A KONECT RESILIA AORTIC VALVED CONDUIT (AVC) EXHIBITED BLEEDING AND TAMPONADE REQUIRING REOPERATION FOR REINTERVENTION ON THE GRAFT ONLY ON POD #1. THE DEVICE REMAINED IMPLANTED. ON POD #8, PATIENT HAD A TTE WHICH DEMONSTRATED AORTIC MEAN GRADIENT OF 8 MMHG, EOA 2.6 CM2, AND LVEF OF 55%. THE PATIENT WAS DISCHARGED TO AN ACUTE CARE HOSPITAL ON POD #18. ON 1-YEAR FOLLOW-UP CT, IT SHOWED NO ABNORMALITIES.

  Patient problems: Cardiac Tamponade

  MAUDE report 23058609 ↗
• InjuryJul 28, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT A 27MM 11060A AORTIC VALVED CONDUIT WAS FOUND TO HAVE A TRIGGERED TAGALERT "2". OR NURSE DID NOT NOTICE UNTIL AFTER THE DEVICE WAS IMPLANTED. PER CUSTOMER, PATIENT WAS BROUGHT IN EMERGENTLY WITH AN AORTIC ANEURYSM. THE SURGEON CALLED FOR THE 27 KONECT. RN CHECKED EXPIRATION AND CONFIRMED WITH SURGEON. IT WAS DETERMINED THAT THE VALVE WAS OPENED AND IMPLANTED WHEN THE STAFF NOTICED THE TEMPERATURE TAG TRIGGERS A BLACK 2 IN THE WINDOW. SHE NOTIFIED SURGEON IMMEDIATELY, AND IMPLANTATION WAS ALREADY OCCURRING. THEY WENT AHEAD AND COMPLETED THE SURGERY. THE PATIENT IS CURRENTLY IN ICU. THE DEVICE CAME FROM (B)(6) AS IT WAS A REPLACEMENT UNIT FOR THE SHELF. IT IS BELIEVED THAT THE VALVE GOT TOO HOT UPON ARRIVAL TO THE LOADING DOCK AT THE (B)(6) HOSPITAL WHICH IS COMMON FOR (B)(6) IN THE SUMMERTIME. ALL OTHER VALVES ON THEIR SHELF EXCEPT ONE MITRIS UNIT HAS BEEN TRIGGERED. ALL OTHER ITEMS ON THE SHELF ARE SAFE AND OK IN TEMP TAG WINDOWS.

  Patient problems: Insufficient Information

  MAUDE report 22632852 ↗
• InjuryJun 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 MEDICAL RECORDS, THAT A PATIENT WITH A 27MM 11060A AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 1 YEARS, 4 MONTHS DUE TO GRAFT INFECTION. THE EXPLANTED VALVE WAS REPLACED WITH A 23MM 11060A VALVED CONDUIT. PER MEDICAL RECORDS, PATIENT PRESENTED WITH MRSA BACTEREMIA WITH CONCERN OF GRAFT INFECTION. CTA DEMONSTRATED CONCERN FOR FLUID COLLECTION AROUND GRAFT. TEE DID NOT DEMONSTRATE VEGETATIONS ON THE VALVE. INTRAOPERATIVELY, ABSCESS CAVITIES ON ASCENDING AORTA AND ROOT WERE ENCOUNTERED AND DRAINED. THE 11060A CONDUIT WAS EXPLANTED. A 23MM 11060A VALVED CONDUIT WAS USED IN REPLACEMENT. THE PATIENT WAS BROUGHT TO THE ICU IN CRITICAL CONDITION AND DISCHARGED ON POD#9. THIS IS A 75-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 DA

  Patient problems: Endocarditis; Insufficient Information

  MAUDE report 22355314 ↗
• InjuryJun 13, 2025Insufficient Device Problem Information; Device Stenosis; Insufficient Device Problem Information; Device Stenosis

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A PATIENT WITH A 22MM 11060A AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 2 YEARS, 8 MONTHS DUE TO SEVERE STENOSIS. THE PATIENT PRESENTED WITH CHEST TIGHTNESS AND SHORTNESS OF BREATH. THE PROCEDURE WAS PERFORMED SUCCESSFULLY WITH A 26MM 9755RSL TRANSCATHETER VALVE. THE PATIENT WAS DISCHARGE ON POD#3.

  Patient problems: Chest Pain; Dyspnea; Insufficient Information

  MAUDE report 22207560 ↗
• InjuryMay 2, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 27MM 11060A AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 9 MONTHS DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH A 27MM 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 21953633 ↗
• InjuryMar 18, 2025Intravalvular regurgitation; Intravalvular regurgitation

  IT WAS REPORTED A PATIENT WITH A 27MM 11060A AORTIC VALVED CONDUIT IMPLANTED ONE (1) YEAR, FOUR (4) MONTHS, UNDERWENT VALVE-IN-VALVE PROCEDURE DUE TO AORTIC INSUFFICIENCY. TAVR WAS PERFORMED WITH A 26MM 9750TFX TRANSCATHETER VALVE.

  Patient problems: Insufficient Information

  MAUDE report 21635454 ↗
• InjuryJan 14, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED VIA THE PATIENT REGISTRY THAT A PATIENT WITH A 27MM 11060A AORTIC VALVED CONDUIT UNDERWENT REDO AORTIC VALVE REPLACEMENT AFTER AN IMPLANT DURATION OF FOUR (4) MONTHS DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH A 23MM 11060A AORTIC 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: Insufficient Information

  MAUDE report 21146880 ↗
• InjuryDec 2, 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 VALVED CONDUIT MODEL 11060A27 IMPLANTED IN THE AORTIC POSITION WAS EXPLANTED AFTER AN IMPLANT DURATION OF ONE (1) DAY FOR UNKNOWN REASON. A 29MM VALVED CONDUIT WAS IMPLANTED IN REPLACEMENT.

  Patient problems: Insufficient Information

  MAUDE report 20819560 ↗
• InjuryJun 28, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 27MM 11060A, IMPLANTED IN AORTIC POSITION, UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 3 YEARS AND 1 MONTH DUE TO UNKNOWN REASONS. THE VALVE WAS REPLACED WITH A 26MM 9755RSL VALVE.

  Patient problems: Insufficient Information

  MAUDE report 19639011 ↗
• InjuryJun 17, 2024Microbial Contamination of Device; Insufficient Device Problem Information; Microbial Contamination of Device; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 27MM 11060A AORTIC VALVE WAS EXPLANTED AND REPLACED WITH A 25MM 11060A AORTIC VALVE AFTER AN IMPLANT DURATION OF ONE (1) YEAR, 4 MONTHS AND 21 DAYS DUE TO STREP A BACTEREMIA ENDOCARDITIS WITH PERIAORTIC ROOT ABSCESS. THE PATIENT PRESENTED WITH ABDOMINAL PAIN AND CHEST PAIN. THE PATIENT WAS TRANSPORTED WHILE INTUBATED TO THE ICU IN CRITICAL CONDITION. PER MEDICAL RECORDS, PATIENT PRESENTED WITH CHEST PAIN IN MULTISYSTEM ORGAN FAILURE AND GROUP A STREP BACTEREMIA IN THE SETTING OF A RECENT TOOTH INFECTION. THE PATIENT WAS ADMITTED TO ICU DUE TO UNSTABLE HEMODYNAMICS, CHB, AND IV ANTIBIOTIC ADMINISTRATION PER INFECTIOUS DISEASE. TEE DEMONSTRATED PERIAORTIC ABSCESS WITHOUT EVIDENCE OF VEGETATION OR VALVULAR DYSFUNCTION. INTRAOPERATIVELY, SIGNIFICANT INFLAMMATION AND PHLEGMONOUS CHANGES WERE NOTED NEAR THE AORTIC ROOT. THERE WAS EXTENSIVE DESTRUCTION OF THE AORTIC ROOT GRAFT MATERIAL AND INFECTED TISSUE WAS REMOVED. THERE WAS NO OBVIOUS PURULENT MATERIAL. A 25MM 11060A VALVED CONDUIT WAS SECURED. THE PATIENT WAS WEANED FROM BYPASS AND SENT TO THE ICU IN CRITICAL CONDITION. POST-OP TEE SHOWED WELL-SEATED AORTIC VALVE WITH MEAN GRADIE

  Patient problems: Endocarditis; Insufficient Information

  MAUDE report 19547138 ↗
• InjuryMay 7, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 27MM 11060A AORTIC VALVED CONDUIT, IMPLANTED IN AORTIC POSITION, WAS EXPLANTED AFTER AN IMPLANT DURATION OF 5 MONTHS DUE TO UNKNOWN REASONS. THE VALVE WAS REPLACED WITH ANOTHER 27MM 11060A VALVED CONDUIT.

  Patient problems: Insufficient Information

  MAUDE report 19262072 ↗
• InjuryJan 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH A 27 11060A VALVED CONDUIT UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 1 MONTH DUE TO THROMBUS ON THE LEAFLETS SECONDARY TO HIT. THE PATIENT DEVELOPED HEPARIN INDUCED THROMBOCYTOPENIA (HIT) SHORTLY AFTER AVR SURGERY. DUE TO THIS EMERGENT SITUATION, THE PATIENT HAD TO BE TREATED AND THEN DEVELOPED THROMBUS ON THE LEAFLETS, WHICH CAUSED THE VALVE TO FAIL. THE PROCEDURE WAS PERFORMED WITH A 26MM 9755RSL TRANSCATHETER VALVE SUCCESSFULLY.

  Patient problems: Thrombocytopenia

  MAUDE report 18611057 ↗
• InjuryJan 15, 2024Fluid/Blood Leak; Gradient Increase; Difficult to Open or Close; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Fluid/Blood Leak; Gradient Increase; Difficult to Open or Close; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A 27MM 11060A UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 28 DAYS DUE TO LEAFLET NOT FUNCTIONING PROPERLY, STENOSIS, INSUFFICIENCY, AND THROMBUS CAUSED BY NON-EDWARDS DEVICE WITH HIT. THE TAVR WAS PERFORMED WITH AN 26MM 9755RSL TRANSCATHETER VALVE. PATIENT INITIALLY UNDERWENT AORTIC ROOT REPLACEMENT WITH 27MM KONECT WITH IMPELLA PLACEMENT ON (B)(6) 2023. ECHO SHOWED NONCORONARY LEAFLET IS NOT FUNCTIONING PROPERLY AND SURGEON SUSPECTED IT WAS BECAUSE OF THE IMPELLA DEVICE. THE PATIENT DEVELOPED HIT AND WAS PLACED ON ARGOTROBAN. THE IMPELLA WAS REMOVED COMPLICATED BY BLEEDING. MEDICAL RECORDS SHOWED ON TEE BOTH NARROWING AND INSUFFICIENCY OF THE BIOPROSTHETIC VALVE RELATED TO PARTIAL THROMBOSIS IN THE SETTING OF HIT, WITH AT LEAST TWO OF THE THREE LEAFLETS WITH RESTRICTED MOTION POSITIONED ADJACENT TO THE NATIVE RCC AND LCC. THE PATIENT WAS DEEMED A POOR SURGICAL CANDIDATE; THEREFORE, A VALVE-IN-VALVE WAS PERFORMED WITH A 26MM S3UR. TEE POST IMPLANT OF TRANSCATHETER VALVE SHOWED GOOD VALVE POSITIONING AND NO PERIVALVULAR LEAK. THE PATIENT LEFT THE CTICU IN STABLE CONDITION.

  Patient problems: Insufficient Information; Thrombocytopenia; Thrombosis/Thrombus

  MAUDE report 18511275 ↗
• InjuryJan 3, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED VIA IMPLANT PATIENT REGISTRY THAT A 27MM AORTIC VALVED CONDUIT WAS EXPLANTED AND REPLACED WITH A 23MM VALVED CONDUIT AFTER AN IMPLANT DURATION OF 1 YEAR, 3 MONTHS DUE TO UNKNOWN REASONS.

  Patient problems: Insufficient Information

  MAUDE report 18436596 ↗
• InjuryOct 2, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED VIA THE PATIENT REGISTRY THAT A PATIENT WITH A 27MM 11060A AORTIC VALVED CONDUIT UNDERWENT A REDO AORTIC VALVE REPLACEMENT PROCEDURE AFTER AN IMPLANT DURATION OF ONE (1) YEAR, 10 MONTHS DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH A 27MM 11060A VALVED CONDUIT.

  Patient problems: Insufficient Information

  MAUDE report 17852443 ↗
• InjurySep 8, 2023Insufficient Device Problem Information; Patient Device Interaction Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  IT WAS LEARNED FROM THE IMPLANT PATIENT REGISTRY AND MEDICAL RECORDS THAT A MODEL 27MM 11060A AORTIC VALVED CONDUIT WAS EXPLANTED AND REPLACED WITH A 11060A 27MM AORTIC VALVED CONDUIT AFTER AN IMPLANT DURATION OF 7 MONTHS DUE TO ENTEROCOCCUS FAECALIS BIOPROSTHETIC ENDOCARDITIS AND VEGETATION. PER MEDICAL RECORDS, PATIENT PRESENTED TO HOSPITAL WITH INFECTIVE NEPHRITIS. BLOOD CULTURES RETURNED POSITIVE FOR GRAM-POSITIVE COCCI IN PAIRS AND FOUND TO BE ENTEROCOCCUS FAECALIS. PATIENT WAS STARTED ON IV ANTIBIOTICS. INFECTIVE ENDOCARDITIS WITH SEPTIC EMBOLI AND INFLAMMATORY CHANGES ON CT SCAN IN THE MEDIASTINUM SURROUNDING THE PROXIMAL THORACIC AORTA. THE 27MM 11060A VALVED CONDUIT WAS EXPLANTED AND NOTED TO HAVE LARGE VEGETATION ON IT. PATIENT UNDERWENT RE-DO BENTALL. THE EXPLANTED VALVED CONDUIT WAS REPLACED WITH ANOTHER 27MM 11060A VALVED CONDUIT. THE PATIENT WAS TRANSPORTED TO THE ICU IN CRITICALLY ILL BUT STABLE CONDITION. PATIENT WAS DISCHARGED TO LONG TERM ACUTE CARE FACILITY ON POD# 10. PATHOLOGY REPORT, PROSTHETIC VALVE LEAFLETS WITH ADHERENT FIBRIN AND NEUTROPHILS; COMPATIBLE WITH CLINICAL HISTORY OF ENDOCARDITIS.

  Patient problems: Endocarditis; Insufficient Information

  MAUDE report 17712894 ↗