BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING

    MDR report key: 1412649 · Received July 13, 2009

    Report

    Report Number
    2015691-2009-11064
    Event Type
    Injury
    Date Received
    July 13, 2009
    Date of Event
    April 27, 2009
    Report Date
    June 26, 2009
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    PMA / PMN Number
    K926138
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IN 2009, (THROUGH FOLLOW-UP WITH THE SURGEON), IT WAS LEARNED THAT THE DEVICE WAS EXPLANTED DUE TO "RING DEHISCENCE".

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. THIS EVENT WAS DETERMINED TO BE REPORTABLE PER EDWARDS LIFESCIENCES PROCEDURES. THE INFORMATION WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY. A DEVICE HISTORY RECORD REVIEW IS IN PROCESS. TWO REQUESTS WERE MADE (VIA FAX) FOR THE DEVICE, OPERATIVE REPORT, AND ADDITIONAL INFORMATION; HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED AND NO DEVICE WAS RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED APPROXIMATELY AFTER AN IMPLANT DURATION OF 54 MONTHS, DUE TO UNKNOWN REASONS. NO FURTHER DETAILS WERE PROVIDED.

    Description of Event or Problem · 1

    ON AUGUST 17, 2009, A DOCTOR REPORTED TO SYBRON IMPLANT SOLUTIONS GMBH THAT A PITT EASY IMPLANT ABUTMENT HEX HAD FRACTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING ANNULOPLASTY RING KRH EDWARDS LIFESCIENCES 4450 04E001

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention