BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 3749724 · Received April 14, 2014

    Report

    Report Number
    2953161-2014-00041
    Event Type
    Injury
    Date Received
    April 14, 2014
    Date of Event
    March 31, 2014
    Report Date
    April 3, 2014
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PATIENT MEDICATIONS - BETA BLOCKERS, COUMADIN, HYDROCHLOROTHIAZIDE, DILTIAZEM, SYNTHROID, STRATTERA, AND SERTALINE.THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS.THE ROOT CAUSE OF THE ENDOLEAK IS REPORTEDLY UNKNOWN. ADDITIONAL DEVICE IMPLANTED AND INVOLVED IN THIS EVENT: PXC141200/7201918.

    Description of Event or Problem · 1

    ON (B)(6) 2009, THE PATIENT UNDERWENT TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM WITH TWO GORE EXCLUDER AAA ENDOPROSTHESES. ON (B)(6) 2014, THE PATIENT PRESENTED TO THE HOSPITAL WITH BACK PAIN, AND FOLLOW-UP IMAGING IDENTIFIED A PROXIMAL TYPE I ENDOLEAK AND ANEURYSM ENLARGEMENT (AMOUNT UNKNOWN) TO 6.6 X 5.5 CM. THE CAUSE OF THE ENDOLEAK IS REPORTEDLY UNKNOWN. ON (B)(6) 2014, AN ADDITIONAL PROCEDURE WAS PERFORMED TO TREAT THE ENDOLEAK. IT WAS REPORTED THERE WAS NOT ENOUGH PROXIMAL NECK LENGTH TO EXTEND PROXIMALLY, SO THE PHYSICIAN ELECTED TO EXPLANT BOTH DEVICES AND SURGICALLY REPAIR THE ANEURYSM. THE DEVICES WERE EXPLANTED WITH NO ISSUE, AND THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227019 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 06673109

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R