BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING

    MDR report key: 1600120 · Received February 16, 2010

    Report

    Report Number
    2015691-2010-12728
    Event Type
    Injury
    Date Received
    February 16, 2010
    Report Date
    January 18, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    PMA / PMN Number
    K926138
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS LEARNED THROUGH PUBLICATION IN THE (B) (6) ASSOCIATION FOR THORACIC SURGERY 2010, GEN THORAC CARDIOVASC SURG (2010) 58:49-52 DOI 10.1007/S 11748-009-0479-0. THE EVENT OCCURRENCE DATE IS UNKNOWN. SERIAL NUMBER OF THE DEVICE IS UNKNOWN; THEREFORE, NO DHR CAN BE DONE. THIS WAS DETERMINED REPORTABLE PER EDWARDS LIFESCIENCES PROCEDURES. DEVICE UNAVAILABLE FOR RETURN.

    Description of Event or Problem · 1

    REPORTEDLY, THE DEVICE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 15.17 MONTHS DUE TO ENDOCARDITIS. PER THE PUBLICATION: A (B) (6) MAN WAS DIAGNOSED WITH ACTIVE MITRAL ENDOCARDITIS 14 MONTHS AFTER MITRAL VALVE REPAIR. THE RESPONSIBLE ORGANISM WAS (B) (6) INFECTION. TEE SHOWED AN 8-MM PATCH OF VEGETATION ADHERING TO THE ANTERIOR PART OF THE ARTIFICIAL RING. ALTHOUGH ANTIBIOTICS (PIPERACILLIN, MINOCYCLINE, IMIPENEM/CILASTATIN, AND AMPICILLIN) WERE ADMINISTERED, THE VEGETATION GREW TO 30 MM. REOPERATION WAS PERFORMED 35 DAYS AFTER THE DIAGNOSIS. BEFORE SURGERY, THERE WAS MILD MITRAL REGURGITATION WITHOUT CONGESTIVE HEART FAILURE. RE-REPAIR WAS PERFORMED BY REMOVING THE VEGETATION AND THE ARTIFICIAL RING, AND MATTRESS SUTURES REPAIRED THE CIRCUMFERENTIAL SULCUS FORMED BY THE ARTIFICIAL RING. TEICOPLANIN AND MINOCYCLINE WERE ADMINISTERED FOR 6 WEEKS. AT 20 MONTHS, INFECTIVE ENDOCARDITIS WAS ABSENT. RESIDUAL MITRAL REGURGITATION HAS BEEN CONSISTENTLY MILD. ALTHOUGH ACTIVE MITRAL ENDOCARDITIS AFTER MITRAL VALVE REPAIR IS RARE, PROMPT REOPERATION SHOULD BE CONSIDERED IF THE RESPONSIBLE ORGANISM IS DRUG-RESISTANT AND INFECTION SPREADS TO THE ARTIFICIAL RING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Hospitalization