KONECT RESILIA 11060A (REF 11060A21)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00690103201376), received between Dec 15, 2023 and May 22, 2025 — classified as 6 injuries.

The most frequently reported specific device problem is “Device Stenosis” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMay 22, 2025Device Stenosis; Intravalvular regurgitation; Device Stenosis; Intravalvular regurgitation

  IT WAS REPORTED THAT A PATIENT WITH A 21MM 11060A KONECT AORTIC VALVED CONDUIT, IMPLANTED IN THE PULMONIC POSITION RV TO PA, UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF THREE (3) YEARS, SEVEN (7) MONTHS DUE TO STENOSIS. THE PATIENT IS ASYMPTOMATIC. AN ATTEMPT WAS MADE TO FRACTURE THE VALVE SEWING RING WITHOUT OBVIOUS FRACTURE PRIOR TO IMPLANTING THE TRANSCATHETER VALVE. THE PROCEDURE WAS PERFORMED WITH A 20MM 9750TFX TRANSCATHETER VALVE SUCCESSFULLY. PATIENT TOLERATED THE PROCEDURE WELL AND WAS IN STABLE CONDITION AND WAS DISCHARGED POD#1.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22071615 ↗
• InjuryMay 19, 2025Calcified; Adverse Event Without Identified Device or Use Problem; Calcified; Adverse Event Without Identified Device or Use Problem

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND MEDICAL RECORDS, THAT A 21MM 11060A AORTIC VALVED CONDUIT WAS EXPLANTED AFTER AN IMPLANT DURATION OF 1 YEAR, 6 MONTHS DUE TO AORTIC ROOT ABSCESS AND INFECTED PSEUDOANEURYSM. THE EXPLANTED DEVICE WAS REPLACED WITH A 23MM 11060A AORTIC VALVED CONDUIT. CONCOMITANTLY DID TRICUSPID VALVE REPAIR WITH MC3 RING. THE PATIENT TOLERATED THE PROCEDURE WELL AND DISCHARGED POD#1. PER MEDICAL RECORDS, THE PATIENT PRESENTED WITH AORTIC ROOT ABSCESS AND PSEUDOANEURYSM. THE PATIENT UNDERWENT AN AORTIC ROOT REPLACEMENT AND A TRICUSPID VALVE REPAIR. THE INTRAOPERATIVE TEE REVEALED AN AORTIC ROOT ABSCESS, SEVERE TRICUSPID REGURGITATION AND REDUCED RV FUNCTION. DURING THE OPERATION, THE IMPLANTED VALVE EXHIBITED SIGNIFICANT INFECTION. HOWEVER, THERE WERE NO INDICATIONS OF ENDOCARDITIS OR STRUCTURAL VALVE DETERIORATION. THE 21MM 11060 KONECT RESILIA AORTIC VALVE CONDUIT WAS EXPLANTED AND THE PREVIOUS PLEDGETS WERE REMOVED. THE ANNULUS WAS SIZED TO IMPLANT A 23MM 11060A KONECT RESILIA AORTIC VALVE CONDUIT. TEE DEMONSTRATED REDUCED RV FUNCTION, NO TRICUSPID REGURGITATION, AND NO AORTIC INSUFFICIENCY. THE PATIENT TOLERATED THE PROCEDURE WELL AND TRANSFERRE

  Patient problems: Pseudoaneurysm

  MAUDE report 22045875 ↗
• InjuryMar 7, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 21MM 11060A AORTIC VALVED CONDUIT UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF FOUR (4) YEARS, ONE (1) MONTH DUE TO SEVERE STENOSIS. THE PROCEDURE WAS PERFORMED WITH A 23MM 9755RSL TRANSCATHETER VALVE SUCCESSFULLY WITH BALLOON VALVE FRACTURE OF THE KONECT VALVED CONDUIT. PER MEDICAL RECORDS, THE PATIENT WAS A TRANSFER FROM ANOTHER HOSPITAL FOR CARDIOGENIC SHOCK AND MULTIFOCAL PNEUMONIA, SEPTIC SHOCK ON VA ECMO AND IMPELLA, WITH SEVERE BIOPROSTHETIC AORTIC STENOSIS.

  Patient problems: Cardiogenic Shock; Insufficient Information

  MAUDE report 21551726 ↗
• InjuryFeb 3, 2025Intravalvular regurgitation; Intravalvular regurgitation

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A 21MM 11060A AORTIC VALVED CONDUIT WAS EXPLANTED AFTER AN IMPLANT DURATION OF 5 MONTHS DUE TO SEVERE AORTIC INSUFFICIENCY IN THE PRESENCE OF A PSEUDOANEURYSM. THE PATIENT PRESENTED WITH HEART FAILURE. THE EXPLANTED DEVICE WAS REPLACED WITH A 23MM 11060A AORTIC VALVED CONDUIT. THE PATIENT WAS IN RECOVERY POST PROCEDURE. PER MEDICAL RECORDS, TEE SHOWED MILDLY REDUCED LV FUNCTION WITH PSEUDOANEURYSM ARISING FROM THE LEFT SIDE OF THE ROOT, SEVERE TR. PATIENT UNDERWENT RE-DO BENTALL IN ADDITION TO TVR. THE PATIENT TOLERATED THE PROCEDURE WELL. THE PATIENT WAS TRANSFERRED TO THE ICU INTUBATED AND HEMODYNAMICALLY STABLE CONDITION. 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. SU

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 21297787 ↗
• InjuryNov 11, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 21MM 11060A AORTIC VALVED CONDUIT IN AORTIC POSITION WAS EXPLANTED AND REPLACED WITH A 23MM 3300TFX AORTIC VALVE AFTER AN IMPLANT DURATION OF 8 MONTHS, 25 DAYS DUE TO UNKNOWN REASON. 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 20650008 ↗
• InjuryDec 15, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED VIA THE PATIENT REGISTRY THAT A PATIENT WITH A 21MM 11060A KONECT VALVED CONDUIT UNDERWENT A REDO AORTIC VALVE REPLACEMENT PROCEDURE AFTER AN IMPLANT DURATION OF FIVE (5) MONTHS DUE TO UNKNOWN REASONS. THE EXPLANTED VALVED CONDUIT WAS REPLACED WITH ANOTHER 21MM 11060A KONECT.

  Patient problems: Insufficient Information

  MAUDE report 18340777 ↗