BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 3143185 · Received May 25, 2013

    Report

    Report Number
    2953161-2013-00079
    Event Type
    Injury
    Date Received
    May 25, 2013
    Date of Event
    May 9, 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
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. CONCLUSIONS: THE ROOT CAUSE OF THE MIGRATION IS UNKNOWN. DEVICES IMPLANTED AND INVOLVED IN THIS EVENT: PCC121000/031540611 AND PCA260300/030451806.

    Description of Event or Problem · 1

    ON (B)(6) 2004, THE PATIENT WAS IMPLANTED WITH THREE GORE EXCLUDER BIFURCATED ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ON AN UNKNOWN DATE, FOLLOW-UP IMAGING IDENTIFIED DISTAL MIGRATION (AMOUNT UNKNOWN) OF ONE OF THE DEVICES. ON (B)(6) 2013, AN ADDITIONAL PROCEDURE WAS PERFORMED WHEREBY THE PREVIOUSLY IMPLANTED DEVICES WERE RELINED WITH FIVE ADDITIONAL DEVICES. IT WAS REPORTED THERE WAS NO VISIBLE ENDOLEAK SEEN DURING THE PROCEDURE, AND THE ORIGINALLY IMPLANTED TRUNK AND AORTIC EXTENDER APPEARED TO BE IMPLANTED AT THE LEVEL OF THE ANEURYSM. FINAL ANGIOGRAPHY SHOWED EXCLUSION OF THE ANEURYSM WITH NO EVIDENCE OF ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232743 GORE EXCLUDER AAA ENDOPROSTHESIS MIH / SYSTEM ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES 030363006

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization| R METOPROLOL| GLIPIZIDE| FERROUS SULFATE| CETRIZINE| CHOLECALCIFEROL| VITAMINS| TRAVOPROST| LOSARTAN POTASSIUM| HYDROCODONE| ATORVASTATIN| METFORMIN| SITAGLIPTIN| MAGNESIUM OXIDE| WARFARIN| AMOXICILLIN| CALCIUM CITRATE| LEVOBUNOLOL