BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PHYSIO II ANNULOPLASTY RING

    MDR report key: 1953269 · Received January 7, 2011

    Report

    Report Number
    2015691-2011-14635
    Event Type
    Injury
    Date Received
    January 7, 2011
    Date of Event
    September 17, 2010
    Report Date
    December 8, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    PMA / PMN Number
    K083470
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE.

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: UNFORTUNATELY, THE DEVICE IS UNAVAILABLE FOR EVALUATION. THE DEVICE HISOTRY RECORD (DHR) REVIEW IS CURRENTLY IN PROCESS.

    Description of Event or Problem · 1

    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. IN THIS CASE, IT WAS LEARNED THAT THE DEVICE WAS EXPLANTED AT IMPLANT DUE TO A SIZING ISSUE. ACCORDING TO THE OPERATIVE REPORT, AFTER THE RING WAS IMPLANTED, A TEE WAS PERFORMED WHICH DEMONSTRATED SIGNIFICANT AORTIC INSUFFICIENCY THAT HAD NOT BEEN PRESENT. THE SUSPICION WAS THAT IT WAS THE REPAIR STITCH THAT HAD DISTORTED THE AORTIC ANNULUS. THEREFORE, THE RING WAS REMOVED AND REPLACED WITH A SMALLER EDWARDS ANNULOPLASTY RING, WHICH RESULTED IN NO RESIDUAL MITRAL REGURGITATION. PER THE HEALTH-CARE PROVIDER, THERE WAS NOT A DEVICE MALFUNCTION, AND THE EDWARDS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PHYSIO II ANNULOPLASTY RING ANNULOPLASTY RING KRH EDWARDS LIFESCIENCES 5200 R-10G1791

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention