BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE DRYSEAL SHEATH

    MDR report key: 2020158 · Received March 7, 2011

    Report

    Report Number
    2017233-2011-00104
    Event Type
    Injury
    Date Received
    March 7, 2011
    Date of Event
    February 17, 2011
    Report Date
    March 5, 2011
    Manufacturer
    W.L. GORE & ASSOCIATES, INC.
    Product Code
    DYB
    PMA / PMN Number
    K093791
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL, METHOD: A REVIEW OF THE MFG PAPERWORK HAS BEEN CONDUCTED. RESULTS: THE REVIEW OF THE MFG PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PT UNDERWENT TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM WITH GORE EXCLUDER AAA ENDOPROSTHESIS. IT WAS REPORTED THAT THE DEVICES WERE DEPLOYED WITH NO ISSUE. WHEN THE PHYSICIAN REPORTEDLY RETRACTED THE GORE DRYSEAL SHEATH TO PERFORM FINAL ANGIOGRAPHY, THE PT'S LEFT ILIAC ARTERY RUPTURED. IT WAS REPORTEDLY DETERMINED THAT THE SHEATH COMPRESSED WHILE IN THE ILIAC ARTERY, CREATING A CHANNEL THAT FORMED A SHARP EDGE AT THE RADIOPAQUE MARKER. AS REPORTED, THE SHARP EDGE AT THE RADIOPAQUE MARKER SUBSEQUENTLY TORE THE ILIAC ARTERY. ADD'L GORE EXCLUDER AAA ENDOPROSTHESES WERE REPORTEDLY IMPLANTED TO EXTEND PAST THE HYPOGASTRIC ARTERY AND RUPTURED AREA, AND THE PT RECEIVED 2 UNITS OF BLOOD. FINAL ANGIOGRAPHY SHOWED RESOLUTION OF THE RUPTURE, AND THE PT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE DRYSEAL SHEATH DYB/INTRODUCER, CATHETER DYB W.L. GORE & ASSOCIATES, INC. WLG401 8340593

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R ASPIRIN| ACETAMIN CQD| TRIAMTERINE| PRAVASTATIN| PLAVIX