BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 2820617 · Received October 29, 2012

    Report

    Report Number
    2953161-2012-00193
    Event Type
    Injury
    Date Received
    October 29, 2012
    Date of Event
    September 28, 2012
    Report Date
    October 2, 2012
    Manufacturer
    W. L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ON (B)(6) 2011, THIS PATIENT UNDERWENT TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM WITH THREE GORE EXCLUDER AAA ENDOPROSTHESES. ON (B)(6) 2012, FOLLOW-UP ANGIOGRAPHY SHOWED EITHER A PROXIMAL TYPE I ENDOLEAK OR A TYPE III ENDOLEAK REPORTEDLY DUE TO A HOLE IN THE TRUNK. IT WAS REPORTED THE DEVICE HAD MIGRATED DISTALLY 7 MM FROM THE RENAL ARTERIES, AND THE ANEURYSM HAD GROWN FROM 5 TO 5.8 CM. THE CONTRAST IS REPORTEDLY SHOWING 47 MM DISTAL TO THE TOP OF THE DEVICE. ON (B)(6) 2012, AN INTERVENTION WAS PERFORMED TO TREAT THE ENDOLEAK. IT WAS REPORTED THAT A HOLE IN THE PXT231416 WAS SEEN AT THE BOTTOM OF THE NECK BEFORE THE BIFURCATION. IT IS UNKNOWN WHAT CAUSED THE REPORTED HOLE. THE ORIGINALLY IMPLANTED DEVICES WERE RELINED WITH FOUR ADDITIONAL GORE EXCLUDER AAA ENDOPROSTHESES. FINAL ANGIOGRAPHY SHOWED NO EVIDENCE OF THE TYPE III ENDOLEAK, AND THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE EXCLUDER AAA ENDOPROSTHESIS MIH / SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES 8293466

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization| R HYDROCHLOROZINE| ZINC| CALCIUM CITRATE| TRIMINASOL| RANITIDINE| PLAVIX| PRILOSEC| CLOBETAZOLE| MAGNESIUM