BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING

    MDR report key: 3021992 · Received March 26, 2013

    Report

    Report Number
    2015691-2013-19661
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    May 20, 2011
    Report Date
    February 26, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    K926138
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: ENDOCARDITIS, OCCURRING MORE THAN 60 DAYS AFTER HEART VALVE SURGERY, IS USUALLY CAUSED BY AN INFECTION WHICH OCCURS ELSEWHERE IN THE BODY, AND THEN SEEDS THE VALVE. THE MOST FREQUENT CAUSES ARE DENTAL PROCEDURES, UROLOGICAL INFECTIONS AND INTERVENTIONS, AND INDWELLING CATHETERS. EDWARDS LIFESCIENCES HAS VALIDATED METHODS FOR STERILIZATION OF ALL DEVICES WHICH ENSURES PRODUCT STERILITY. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. UNFORTUNATELY, THE ANNULOPLASTY RING WAS NOT RETURNED TO EDWARDS FOR ANALYSIS; THEREFORE, THE ROOT CAUSE OF THIS EVENT CANNOT BE CONFIRMED. HOWEVER, THE SURGEON HAS INDICATED THAT THIS EVENT WAS NOT DUE TO ANY DEVICE RELATED ISSUES. THE SOURCE OF THE PATIENT'S INFECTION WAS LIKELY CAUSED BY THE LONG-TERM DIALYSIS VIA A DEMERS CATHETER AS REPORTED. NO FURTHER ACTION ARE POSSIBLE WITH THE AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED VIA THE IMPLANT PATIENT REGISTRY THAT THE MITRAL RING WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 1 YEAR AND 8 MONTHS. AS STATED BY THE SURGEON. "THE ANULOPASTIERING WAS EXPLANTED DUE TO ENDOKARDITIS WITH NATIVE VALVE DESTRUCTION (STAPHYLOCOCCUS AUREUS). THE PATIENT GOT THIS ENDOCARDITIS AFTER LONG-TERM DIALYSIS VIA A DEMERS CATHETER BECAUSE OF TERMINAL RENAL FAILURE. THE RING AND NATIVE VALVE HAD TO BE EXPLANTED AND REPLACED BY A PROSTHETIC VALVE. THE REPLACEMENT WAS NOT PERFORMED BECAUSE OF DEVICE RELATED PROBLEMS." THE DEVICE WAS EXPLANTED AND THE PATIENT'S MITRAL VALVE WAS REPLACED WITH A NEW EDWARDS BIOPROSTHETIC VALVE. NO OTHER DETAILS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123917 CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 4450 2855574

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| L| R