BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE-TEX VASCULAR GRAFT

    MDR report key: 2850832 · Received November 20, 2012

    Report

    Report Number
    2017233-2012-00770
    Event Type
    Injury
    Date Received
    November 20, 2012
    Date of Event
    October 6, 2012
    Report Date
    October 12, 2012
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    DSY
    PMA / PMN Number
    K880167
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MFG RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECS. IMAGE PROVIDED DOES NOT ALLOW FOR EVAL IN RELATIONSHIP TO THE EVENT. ENGINEERING AND HISTOLOGICAL ANALYSIS CURRENTLY IN PROGRESS.

    Description of Event or Problem · 1

    ON (B)(6) 2012, A PT WAS IMPLANTED WITH TWO GORE-TEX VASCULAR GRAFTS IN AN AXILLO-FEMORAL AND A FEMORO-POPLITEAL BYPASS PROCEDURE. IT WAS REPORTED TO GORE THAT ON (B)(6) 2012, THE PT PRESENTED WITH A HEMATOMA IN THE UNDER ARM AREA. AN OPEN SURGERY WAS PERFORMED TO REMOVE THE HEMATOMA. THE ANASTOMOSIS WAS RE-OPENED AT THE AXILLARY ARTERY. IT WAS REPORTED THAT AFTER REMOVING THE HEMATOMA AND UPON COMPLETION OF THE ANASTOMOSIS, THE GRAFT DISRUPTED HORIZONTALLY IN THE MIDDLE OF THE PROSTHESIS. IT WAS STATED THAT THE RUPTURE WAS DISTANT FROM THE ANASTOMOSIS AND IN AN AREA THAT NO CLAMPING HAD PREVIOUSLY OCCURRED. CLOTS WERE OBSERVED IN THE AREA OF THE DISRUPTION. CLAMPS WERE USED TO CONTROL THE BLEEDING. THE PHYSICIAN CONCLUDED THAT THE GRAFT RUPTURED DUE TO AN ACUTE THROMBOSIS. A NEW GORE-TEX VASCULAR GRAFT WAS SUTURED BETWEEN THE REMAINING PARTS OF THE GRAFT. THE PT IS FINE. ONE CEMENTER OF THE GRAFT ON EACH SIDE OF THE RUPTURE LINE WAS REMOVED AND IS BEING RETURNED TO GORE FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE-TEX VASCULAR GRAFT DSY/PROSTHESIS, VASCULAR GRAFT DSY W.L. GORE & ASSOCIATES 9877595

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention IT IS UNK WHICH DEVICE IS INVOLVED IN THE EVENT.| LOT NUMBER 9773695 IS ALSO BEING REPORTED FOR| THIS EVENT.