BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 3122503 · Received May 15, 2013

    Report

    Report Number
    2017233-2013-00305
    Event Type
    Injury
    Date Received
    May 15, 2013
    Date of Event
    April 26, 2013
    Report Date
    April 26, 2013
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS - THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2008, THE PATIENT WAS IMPLANTED WITH THREE GORE EXCLUDER AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ON (B)(6) 2013, A FOLLOW-UP COMPUTED TOMOGRAPHY SCAN SHOWED THAT THE PXC181400 HAD PROXIMALLY MIGRATED ~8-9 CM INTO THE ANEURYSM SAC, CAUSING A RIGHT DISTAL TYPE I ENDOLEAK. IT WAS REPORTED, THE MIGRATION WAS CAUSED BY THE AORTA REMODELING AND INADEQUATE SEAL (AMOUNT UNKNOWN) OBTAINED DURING THE IMPLANT PROCEDURE. ON (B)(6) 2013, AN ADDITIONAL PROCEDURE WAS PERFORMED TO TREAT THE PROXIMAL MIGRATION AND ENDOLEAK. IT WAS REPORTED, THE PHYSICIAN WAS ABLE TO GAIN ACCESS INTO THE PXC181400 AND TRACK IT BACK INTO PLACE IN THE ILIAC ARTERY, AND THREE ADDITIONAL DEVICES WERE IMPLANTED FOR DISTAL EXTENSION. FINAL IMAGING SHOWED RESOLUTION OF THE ENDOLEAK, AND THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215082 GORE EXCLUDER AAA ENDOPROSTHESIS MIH/SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 05934332

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| R FLOMAX| ATENOLOL| N-ACETYLCYSTEINE| LOSARTAN| ASPIRIN