BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 3894827 · Received June 25, 2014

    Report

    Report Number
    2953161-2014-00073
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    April 3, 2014
    Report Date
    June 18, 2014
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. ACCORDING TO THE GORE® EXCLUDER® AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO OCCLUSION OF DEVICE OR NATIVE VESSEL.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE PATIENT WAS IMPLANTED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE PATIENT TOLERATED THE INITIAL PROCEDURE. ON (B)(6) 2014, THE PATIENT EXPERIENCED AN ACUTE ISCHEMIA OF THE LEFT LOWER LIMB AND UNDERWENT A FEMORAL THROMBECTOMY PROCEDURE AND ANGIOPLASTY OF THE FEMORAL ARTERY SUPERFICIAL AND POPLITEAL SUPRAGENICULAR. ACCORDING TO THE INFORMATION PROVIDED, THERE WAS NO PROBLEM WITH THE DEVICE. THE CAUSE WAS PROBABLY A STRICTURE IN THE COMMON FEMORAL ARTERY, THE PLACE WHERE THE ENDOPROSTHESIS WAS INTRODUCED. THE ARTERY WAS COMPLETELY OCCLUDED. THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370480 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 12094038

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R