BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORTEX VASCULAR GRAFT

    MDR report key: 192115 · Received October 15, 1998

    Report

    Report Number
    192115
    Event Type
    Death
    Date Received
    October 15, 1998
    Date of Event
    October 4, 1998
    Report Date
    October 14, 1998
    Manufacturer
    W L GORE
    Product Code
    DSY
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    WV, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT ADMITTED 10/2/98 W/DIAGNOSIS OF CELLULITIS LEFT ARM OVER GORTEX GRAFT. PT HAS HISTORY OF 1) END STAGE RENAL DISEASE RECEIVING HEMODIALYSIS 3 TIMES PER WEEK; 2) DIABETES MELLITUS TYPE 2; 3) HYPERTENSION; 4) OBESITY; AND 5) ANEMIA OF CHRONIC DISEASE. PT FOUND BY NURSE ON 10/4/98 LYING IN BED UNRESPONSIVE, PULSELESS AND BREATHLESS. LARGE AMOUNT OF BLOOD NOTED ON FLOOR SURROUNDING BED. RESUSCITATION EFFORTS UNSUCCESSFUL. PT PRONOUNCED BY PHYSICIAN. AUTOPSY REVEALED RUPTURE OF PSEUDOANEURYSM AT AREA OF LEFT ARM ARTERIOVENOUS GRAFT. PSEUDOANEURYSM LOCATED ON ARTERIAL LIMB OF GRAFT. BASED ON RPTR'S INVESTIGATION IT APPEARS THE ORIGINAL ARTERIOVENOUS GORTEX GRAFT WAS PLACED IN PT ON 7/25/97 AT ANOTHER HOSP. THE ARTERIOVENOUS GORTEX GRAFT WAS REVISED ON 4/17/98 AT THIS FACILITY. REVISION WAS MADE TO THE DISTAL (VENOUS) PORTION OF THE GRAFT DUE TO OCCLUSION OF THE VENOUS OUTFLOW TRACT CEPHALIC VEIN. RPTR CONTACTED WL GORE, INITIALLY BY PHONE ON 10/8/98 FOLLOWING REPORT OF AUTOPSY FINDINGS. RPTR ALSO TALKED WITH WL GORE ON 10/12/98 REGARDING THE SAME INCLUDING FDA REPORTING, ETC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORTEX VASCULAR GRAFT Implant GORTEX VASCULAR GRAFT DSY W L GORE UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death PT TREATED FOR CELLULITIS WITH ANTIBIOTICS