BEUDAMED
    FDA Adverse Event Death Summary report: N

    THIN-WALLED FEP RINGED GORE-TEX VASCULAR GRAFT WITH REMOVABL

    MDR report key: 1210986 · Received October 22, 2008

    Report

    Report Number
    2017233-2008-00777
    Event Type
    Death
    Date Received
    October 22, 2008
    Date of Event
    September 18, 2008
    Report Date
    October 21, 2008
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    DSY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Description of Event or Problem · 1

    THE FOLLOWING STATEMENT WAS REPORTED BY THE FIELD SALES ASSOCIATE IN 2008. "DR IMPLANTED A DEVICE FOR AN AXILLO-POPL.L-BYPASS ON TWELVE DAYS EARLIER. PATIENT IS DOING WELL AND SHOULD BE DISCHARGED SEVERAL DAYS LATER. ON FOUR DAYS PRIOR TO ORIGINAL DATE, NEARLY 4 AM IN THE MORNING THE PT GOT BIG PAIN AND SHOWED A BIG HAEMATOMA IN THE AREA OF THE AXILLAR ANASTOMOSIS. THE PT WAS MOVED TO THE INTENSIVE-CARE-UNIT AND FROM THERE DIRECTLY TO THE OR. WHEN HAVING OPENED THE HAEMATOMA WITH AN INCISION BLOOD SPLASHED OUT OF THE INCISION. THE PROSTHESIS HAD TEARED OFF (THE AXILLARY ANASTOMOSIS WAS O.K.) AND THE REST OF THE BYPASS WAS VERY HARD TO FIND. AFTER A BETTER SITUS, THEY GO THE REST OF THE PROSTHESIS, CLAMPED THE PROSTHESIS AND DID AN INTERPOSITION WITH AN 8MM GRAFT SO THAT COULD FLOW AGAIN. WHILE THE TIME OF ALL THESE PROCEDURES, THE PT GOT BLOOD INFUSIONS AND HAS BEEN REANIMATED. IN A BAD GENERAL STATE OF HEALTH, THE PT GOT OUT OF THE OR AND HAS BEEN REMOVED TO THE INTENSIVE-CARE-UNIT, WHERE THE PT DIED AFTER SOME HRS. DR PLACED THE REST OF THE TEARED-OFF PROSTHESIS IN RINGER-SOLUTION. BECAUSE OF THE DEATH OF THE PT, THE DISTRICT ATTORNEY HAD TO BE INVOLVED AND HE HAD TO HAND OUT THE REST OF THE EXPLANT TO THEM FOR EXAMINATION. ON TWO DAYS AFTER THE ORIGINAL DATE, THERE WILL BE A MEDICOLEGAL AUTOPSY OF THE PATIENT'S BODY." FURTHER INVESTIGATION IS PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THIN-WALLED FEP RINGED GORE-TEX VASCULAR GRAFT WITH REMOVABL NONE DSY W.L. GORE & ASSOCIATES WLG401 05060409

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death