BEUDAMED
    FDA Adverse Event Death Summary report: N

    ETHICON

    MDR report key: 1041348 · Received May 13, 2008

    Report

    Report Number
    MW5006830
    Event Type
    Death
    Date Received
    May 13, 2008
    Date of Event
    May 4, 2008
    Report Date
    May 13, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    GAW
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AR, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT REPAIR OF A COARCTATION OF THE AORTA IN 2008. THIS WAS ACCOMPLISHED BY FASHIONING AN END-TO-END ANASTOMOSIS USING A RUNNING 5-0 PROLENE SUTURE. PT DID WELL POST-OPERATIVELY UNTIL 4 DAYS LATER WHEN SHE COLLAPSED AND BECAME UNRESPONSIVE. ATTEMPTS AT CPR AND ECMO FAILED AND A THORACOTOMY WAS PERFORMED REVEALING PARTIAL DEHISCENCE OF THE SUTURE LINE. THE KNOT AND POSTERIOR PORTION OF THE SUTURE LINE WERE INTACT AS WERE THE TISSUE EDGES. THE REMAINING PORTION OF THE SUTURE WAS USED TO REAPPROXIMATE THE EDGES OF THE TISSUE UNTIL ANASTOMOSIS WITH NEW SUTURE COULD BE COMPLETED. BECAUSE THE KNOT WAS SECURE, WE SUSPECT THAT THE SUTURE BROKE. NOTE: THREE SEPARATE LOT NUMBERS OF 5-0 SUTURE WERE OPEN AND IN USE AT THE TIME AND IT IS NOT CLEAR WHICH LOT THIS SUTURE CAME FROM. SUSPECT LOTS ARE AAR113, ABE770 AND ACE 025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON ETHICON 5-0 PROLENE SUTURE GAW ETHICON, INC. * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Death