BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 3923807 · Received July 9, 2014

    Report

    Report Number
    2017233-2014-00353
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    June 13, 2014
    Report Date
    July 10, 2014
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICATIONS: PLAVIX, CRESTOR, LOW-DOSE ASA, LOSARTAN. A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THE LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED ON 7/10/2014: THE PATIENT WAS TREATED BY EXTENDING THE GRAFT TO THE INFRARENAL LEVEL WITH A 20MM HEMASHIELD. THE EXCLUDER DEVICE WAS LEFT IN PLACE. THE PATIENT RECEIVED ONE UNIT OF BLOOD AND IS CURRENTLY DOING FINE.

    Description of Event or Problem · 1

    (B)(6) 2013, A PATIENT UNDERWENT TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM WITH GORE® EXCLUDER® AAA ENDOPROSTHESES (RMT311413/10667422). THE PATIENT'S ANATOMY WAS DESCRIBED AS TORTUOUS BUT NO THROMBUS OR CALCIFICATION WAS REPORTED. ON (B)(6) 2014, THE PATIENT PRESENTED EMERGENTLY TO THE HOSPITAL WITH ABDOMINAL PAIN, AND A NON-CONTRAST CT SCAN SHOWED AN IRREGULAR APPEARANCE OF THE RIGHT LIMB OF THE GRAFT, DESCRIBED AS A ¿HALO¿. ADDITIONALLY AN AORTIC NECK IRREGULARITY WAS SEEN AT THE TRANS-RENAL ARTERY LEVEL. LATER THE SAME DAY A CT SCAN WITH CONTRAST WAS PERFORMED. THERE WAS NO VISIBLE LEAK SEEN WITH THIS SCAN AND NO ANEURYSMAL ENLARGEMENT. THE PATIENT WAS TAKEN TO THE PROCEDURAL SUITE WHERE AN EXPLORATORY PROCEDURE WAS UNDERTAKEN. THE PHYSICIAN INDICATED HE PLANNED TO PERFORM A "HYBRID" PROCEDURE DEPENDING ON HIS FINDINGS. IT IS NOT KNOWN WHETHER THIS WAS CARRIED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401957 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 10667422

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other| R