KONECT RESILIA 11060A (REF 11060A29)Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00690103201406), received between Jul 13, 2022 and Sep 12, 2026 — classified as 18 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (14 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjurySep 12, 2026Insufficient Device Problem Information

  Patient problems: Insufficient Information

  MAUDE report 50745189 ↗
• InjuryApr 3, 2026Insufficient Device Problem Information

  IT WAS LEARNED VIA THE PATIENT REGISTRY THAT A PATIENT WITH A 29MM 11060A AORTIC VALVED CONDUIT UNDERWENT REDO AORTIC VALVE REPLACEMENT AFTER AN IMPLANT DURATION OF TWO (2) YEARS, TWO (2) MONTHS DUE TO UNKNOWN REASONS. THE EXPLANTED DEVICE WAS REPLACED WITH ANOTHER 29MM 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 24779235 ↗
• InjuryMar 14, 2026Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 11060A 29MM VALVED CONDUIT WAS EXPLANTED AFTER AN IMPLANT DURATION OF 3 YEARS AND 10 MONTHS DUE TO UNKNOWN REASON. THE VALVED CONDUIT WAS REPLACED WITH ANOTHER 29MM 11060A CONDUIT.

  Patient problems: Insufficient Information

  MAUDE report 24601419 ↗
• InjuryMar 9, 2026Perivalvular Leak; Device Dislodged or Dislocated; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A 29MM 11060A AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF FOUR (4) YEARS, AND NINE (9) MONTHS DUE TO UNKNOWN REASON. THE EXPLANTED VALVE WAS REPLACED WITH A 25MM 11060A 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: Chest Pain; Insufficient Information

  MAUDE report 24553373 ↗
• InjuryMar 2, 2026Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 29MM 11060A AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 1 YEAR AND 5 MONTHS DUE TO BACTERIAL ENDOCARDITIS. THE VALVE WAS REPLACED WITH A 29MM 11060A AORTIC VALVE. PER MEDICAL RECORDS, THE PATIENT UNDERWENT COMMANDO PROCEDURE WITH REDO-AVR WITH ROOT REPLACEMENT USING 29MM 11060A VALVED CONDUIT AND ASCENDING AORTIC REPLACEMENT, REDO-MVR WITH NON-EDWARDS VALVE, RECONSTRUCTION OF THE AORTO-MITRAL CONTINUITY AND LA DOME WITH A PATCH AND CORONARY BUTTON REIMPLANTATION. THE PATIENT WAS TRANSFERRED TO ICU IN CRITICAL CONDITION.

  Patient problems: Endocarditis; Insufficient Information

  MAUDE report 24478519 ↗
• InjuryJan 29, 2026Device Stenosis

  IT WAS REPORTED AND LEARNED THROUGH MEDICAL RECORDS THAT A PATIENT WITH A 29MM 11060A AORTIC VALVED CONDUIT UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 4 YEARS, 1 MONTH DUE TO SEVERE STENOSIS. THE PATIENT PRESENTED WITH HEART FAILURE, SOB, AND CARDIOGENIC SHOCK. THE PROCEDURE WAS PERFORMED WITH A 29MM 9755RSL TRANSCATHETER VALVE. THE PATIENT WAS DISCHARGED POD #8. PER MEDICAL RECORDS, THE PATIENT PRESENTED WITH CARDIOGENIC SHOCK IN THE SETTING OF NYHA CLASS IV HEART FAILURE AND NSTEMI. TAVR PROCEDURE WAS PERFORMED TO DISABLE THE 29MM VALVED CONDUIT AND IMPLANT A 29MM SUR. THE PATIENT WAS DISCHARGED POD #8. IT WAS NOTED THAT THE PATIENT HAS AN ESRD AND IS CURRENTLY ON HEMODIALYSIS.

  Patient problems: Cardiogenic Shock

  MAUDE report 24214539 ↗
• InjuryOct 21, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 29MM 11060A AORTIC VALVED CONDUIT WAS EXPLANTED AFTER AN IMPLANT DURATION OF 2 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 23350647 ↗
• InjuryOct 7, 2025Perivalvular Leak; Separation Failure; Perivalvular Leak; Separation Failure

  IT WAS REPORTED THAT A PATIENT WITH A 29MM 11060A AORTIC VALVED CONDUIT UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER IMPLANT DURATION OF 3 (THREE) MONTHS, DUE TO DEHISCENCE AND SEVERE PVL. PATIENT PRESENTED WITH HEART FAILURE. TWO 29MM 9755RSL TRANSCATHETER VALVES WERE PLACED TO SEAL THE PVL THROUGH STENT CAGE. PATIENT WAS IN STABLE CONDITION AND HAS BEEN DISCHARGED.

  Patient problems: Insufficient Information; Pseudoaneurysm

  MAUDE report 23240962 ↗
• InjuryJul 3, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT AN UNKNOWN MODEL AORTIC VALVE WAS DISABLED VIA A VALVE-IN-VALVE PROCEDURE AFTER AN UNKNOWN IMPLANT DURATION DUE TO UNKNOWN REASONS. A 9755RSL 29MM TRANSCATHETER VALVE WAS IMPLANTED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 22397088 ↗
• InjuryMar 28, 2025Degraded; Insufficient Device Problem Information; Degraded; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 29MM 11060A AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 3 YEARS, 4 MONTHS DUE TO UNKNOWN REASON. THE PROCEDURE WAS PERFORMED WITH A 26MM 9750TFX TRANSCATHETER VALVE. THE PATIENT WAS IN RECOVERY POST PROCEDURE. EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR SERIALIZED EDWARDS IMPLANTABLE DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET SURVEILLANCE REGISTRY. THROUGH THE REGISTRY, EDWARDS IS NOTIFIED WHEN THESE DEVICES ARE IMPLANTED. IN ADDITION, PATIENT AND/OR DEVICE STATUS MAY BE REPORTED TO THE REGISTRY VIA THE IMPLANTATION DATA CARDS. THE INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL, AND PATIENT FAMILY MEMBERS) AND IS NOT RECEIVED IN THE FORM OF A CONVENTIONAL CUSTOMER COMPLAINT. THE INFORMATION REPORTED MAY OR MAY NOT BE RELATED TO THE EDWARDS DEVICE.

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

  MAUDE report 21727129 ↗
• InjuryOct 14, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 29MM 11060A AORTIC VALVED CONDUIT WAS EXPLANTED AFTER AN IMPLANT DURATION OF ONE (1) YEAR AND FOUR (4) MONTHS DUE TO UNKNOWN REASON. THE EXPLANTED DEVICE WAS REPLACED WITH A 27MM 11060A AORTIC VALVED CONDUIT. THE PATIENT WAS IN RECOVERY POST PROCEDURE. EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR SERIALIZED EDWARDS IMPLANTABLE DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET SURVEILLANCE REGISTRY. THROUGH THE REGISTRY, EDWARDS IS NOTIFIED WHEN THESE DEVICES ARE IMPLANTED. IN ADDITION, PATIENT AND/OR DEVICE STATUS MAY BE REPORTED TO THE REGISTRY VIA THE IMPLANTATION DATA CARDS. THE INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL, AND PATIENT FAMILY MEMBERS) AND IS NOT RECEIVED IN THE FORM OF A CONVENTIONAL "CUSTOMER COMPLAINT". THE INFORMATION REPORTED MAY OR MAY NOT BE RELATED TO THE EDWARDS DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 20446485 ↗
• InjurySep 24, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 29MM 11060A AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 6 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 20293116 ↗
• InjurySep 23, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 29MM 11060A KONECT AORTIC VALVED CONDUIT WAS EXPLANTED AND REPLACED WITH A 29MM 3300TFX AORTIC VALVE AFTER AN IMPLANT DURATION OF 1 YEAR, 8 MONTHS AND 25 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 20278625 ↗
• InjurySep 16, 2024Degraded; Degraded

  IT WAS LEARNED THROUGH MEDICAL RECORDS OF 2024-11882-01 THAT A PATIENT WITH A 29MM 11060A VALVED CONDUIT WAS EXPLANTED AFTER AN IMPLANT DURATION OF 2 MONTHS DUE TO AORTIC ROOT PSEUDOANEURYSM. THE EXPLANTED DEVICE WAS REPLACED WITH A 29MM 11060A VALVE. PER MEDICAL RECORDS, THE PATIENT PRESENTED WITH PERICARDIAL EFFUSION. CT SCAN DEMONSTRATED A PSEUDOANEURYSM AT THE LEVEL OF THE ROOT. HE STABILIZED MEDICALLY AND ANTICOAGULATION WAS WITHDRAWN, AND A REPEAT CT SCAN DEMONSTRATED ENLARGEMENT OF THE PSEUDOANEURYSM. THE PATIENT UNDERWENT REDO STERNOTOMY. INTRAOPERATIVELY, PRELIMINARY EVALUATION SHOWED AORTIC ROOT DEHISCENCE, ESPECIALLY IN THE REGION OF THE RIGHT-NON COMMISSURE. GIVEN THE RIGIDITY OF THE TISSUE SURROUNDING IT AND THE FIBROSIS DUE TO THE PSEUDOANEURYSM/CONTAINED RUPTURE, THE SURGEON DECIDED TO DO A REDO ROOT REPLACEMENT. THE PREVIOUSLY IMPLANTED VALVED CONDUIT WAS EXPLANTED AND WAS REPLACED WITH ANOTHER 29MM 11060A KONECT RESILA AORTIC VALVED CONDUIT. THE AREAS OF THE DISTAL ANASTOMOSIS AND THE VERY DISTAL ASCENDING AORTA WERE THEN EXCISED, AS WAS A SMALL PORTION OF THE LESSER CURVATURE OF THE ARCH. A 28- MM DACRON GRAFT. THE EXPLANTED DEVICE WAS SENT TO PATHOLOGY AND A SPEC

  Patient problems: Pseudoaneurysm

  MAUDE report 20232957 ↗
• InjuryJan 7, 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 29MM 11060A AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF FOUR (4) MONTHS, FOURTEEN (14) DAYS DUE TO UNKNOWN REASONS. THE AVR PROCEDURE WAS COMPLETED WITH ANOTHER 29MM 11060A 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: Endocarditis; Insufficient Information

  MAUDE report 18461442 ↗
• InjuryDec 12, 2023Adverse 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 29MM 11060A AORTIC VALVED CONDUIT WAS EXPLANTED AFTER AN IMPLANT DURATION OF 4 MONTHS AND 11 DAYS DUE TO UNKNOWN REASON. THE EXPLANTED VALVE WAS REPLACED WITH A 29MM 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: Endocarditis; Insufficient Information

  MAUDE report 18313098 ↗
• InjuryAug 18, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED VIA IMPLANT PATIENT REGISTRY THAT A 11060A 29MM AORTIC VALVED CONDUIT WAS EXPLANTED AND REPLACED WITH A 11060A 29MM AFTER AN IMPLANT DURATION OF 9 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 17579301 ↗
• InjuryJul 13, 2022Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT A 29MM VALVED CONDUIT HAD GEL-LIKE DEBRIS INSIDE THE GRAFT AFTER IMPLANT. PER REP THE GRAFT IMMERSED IN SALINE FOR 5 MINUTES. THE GRAFT DID NOT DRY OUT AFTER IMMERSING IN SALINE PRIOR TO IMPLANT. THE DEBRIS WAS SEEN BY SURGEON AND REMOVED USING A SUCKER. THE PRODUCT WAS IN THE REP'S INVENTORY AND KEPT IN PROPER CONDITIONS. THE SURGICAL TEAM COULD CLEARLY SCRAPE THE DEBRIS OFF AND WERE USING THE SUCKER TIP TO REMOVE ANYTHING THEY COULD SEE. IT WAS NOTICED ON BOTH PARTS OF THE GRAFT. PER MEDICAL RECORDS THE PATIENT PRESENTED WITH ASCENDING AORTIC ANEURYSM, AORTIC INSUFFICIENCY, AND UNDERWENT BENTALL PROCEDURE. THE ECHO REVIEWED VALVE WORKING NORMALLY. THE PATIENT WAS DISCHARGED HOME IN GOOD CONDITION ON POD #4.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15003324 ↗