BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 3082964 · Received April 24, 2013

    Report

    Report Number
    2017233-2013-00255
    Event Type
    Injury
    Date Received
    April 24, 2013
    Date of Event
    April 5, 2013
    Report Date
    April 5, 2013
    Manufacturer
    W.L. GORE & ASSOCIATES,INC
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PATIENT UNDERWENT TREATMENT OF A 7.6CM ABDOMINAL AORTIC ANEURYSM WITH THREE GORE EXCLUDER AAA ENDOPROSTHESES. IT WAS REPORTED THERE WAS CALCIFICATION NOTED IN THE PROXIMAL NECK ON THE POSTERIOR WALL OF THE AORTA, BUT FINAL ANGIOGRAPHY SHOWED NO EVIDENCE OF ENDOLEAK AND EXCLUSION OF THE ANEURYSM. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2013, FOLLOW-UP IMAGING SHOWED EVIDENCE OF A PROXIMAL TYPE I ENDOLEAK WITH THE ANEURYSM REPORTEDLY STABLE AT 7.6CM. IT WAS REPORTED THE ENDOLEAK WAS CAUSED BY THE CALCIFICATION IN THE PROXIMAL NECK. ON (B)(6) 2013, AN ADD'L PROCEDURE WAS PERFORMED TO TREAT THE PROXIMAL TYPE I ENDOLEAK. AFTER AN ADD'L DEVICE WAS IMPLANTED PROXIMALLY, FINAL ANGIOGRAPHY SHOWED THAT THE ENDOLEAK PERSISTED. THE PHYSICIAN ELECTED TO CONCLUDE THE PROCEDURE AND WILL CONTINUE TO MONITOR THE PATIENT. THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177917 GORE EXCLUDER AAA ENDOPROSTHESIS MIH/SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES,INC 9268462

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R OMEPRAZOLE| METOPROLOL| WARFARIN| PANTOPRAZOLE| ZOCOR| SIMVASTATIN| LISINOPRIL