BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING

    MDR report key: 3150784 · Received June 6, 2013

    Report

    Report Number
    2015691-2013-20270
    Event Type
    Injury
    Date Received
    June 6, 2013
    Date of Event
    April 14, 2013
    Report Date
    May 9, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    K926138
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RING DEHISCENCE MAY OCCUR EARLY OR LATE. WHEN IT OCCURS IN THE EARLY POST-OPERATIVE PERIOD, IT IS TYPICALLY A RESULT OF AN INADEQUATE VALVE REPAIR IN COMBINATION WITH FRIABLE MYOCARDIAL TISSUE. PER THE OP REPORT, IT WAS UNCLEAR WHY THE RING HAD DEHISCED DURING EXPLANTATION. THE DEVICE WAS NOT RETURNED TO EDWARDS FOR ANALYSIS. IN THIS CASE, THERE IS INSUFFICIENT INFORMATION TO CONCLUSIVELY DETERMINE THE ROOT CAUSE OF THIS EVENT. NO FURTHER ACTIONS ARE POSSIBLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ANNULOPLASTY RING WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 6 WEEKS DUE TO SEVERE MITRAL REGURGITATION, SECONDARY TO DEHISCENCE. PER THE OP REPORT, THE RING WAS FOUND TO BE DEHISCED COMPLETELY WITH THE EXCEPTION OF 2 SUTURES THAT WERE HOLDING IT TO THE POSTERIOR ANNULUS. THERE WAS NO EVIDENCE OF INFECTION. IT APPEARED AS THOUGH THE SUTURES HAD PULLED OUT OF THE TISSUES. IT WAS NOT CLEAR WHY THE SUTURES PULLED THROUGH THE TISSUE. IT WAS DECIDED TO REPLACED THE PATIENT'S MITRAL VALVE. AN EDWARDS BIOPROSTHETIC VALVE WAS IMPLANTED. TRANSESOPHAGEAL ECHOCARDIOGRAM SHOWED GOOD FUNCTION OF THE BIOPROSTHESIS WITH NO PERIVALVULAR LEAKS AND GOOD VENTRICULAR FUNCTION. NO OPERATIVE COMPLICATIONS REPORTED. PATIENT WAS DISCHARGED HOME IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250980 CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 4450 R-11E1684

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R