BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1921570 · Received December 6, 2010

    Report

    Report Number
    2017233-2010-00541
    Event Type
    Injury
    Date Received
    December 6, 2010
    Date of Event
    July 15, 2008
    Report Date
    December 3, 2010
    Manufacturer
    W.L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHODS - A REVIEW OF THE MANUFACTURING RECORDS HAS BEEN CONDUCTED. RESULTS - THE MANUFACTURING RECORDS REVIEW VERIFIED THAT THE LOT(S) MET ALL PRE-RELEASE SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2006, THE PATIENT UNDERWENT TREATMENT WITH GORE EXCLUDER AAA ENDOPROSTHESES. ON (B)(6) 2008, HE PRESENTED WITH BILATERAL LEG PAIN THAT HAD BEEN PROGRESSIVELY WORSENING FOR SEVERAL WEEKS. ON (B)(6) 2008, THE PATIENT WAS RE-ADMITTED TO THE HOSPITAL WITH CLAUDICATION AND STENT-GRAFT THROMBOSIS. HE UNDERWENT OPEN SURGERY FOR AORTO-BIFEM RECONSTRUCTION AND REMOVAL OF THE THROMBOSED DEVICES. THE PATIENT TOLERATED THE PROCEDURE, AND THERE HAVE BEEN NO FURTHER COMPLICATIONS. THERE WAS NO CAUSE FOR THROMBOSIS IN THE MEDICAL RECORDS.

    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, INC. WLG325 03984848

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| L| R BENTYL| PLAVIX| TOPROL| FLEXORIL| ZOCOR| PERCOCET| CHOLASE| PRIADEL| ALBUTEROL