BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 2231252 · Received July 25, 2011

    Report

    Report Number
    2017233-2011-00371
    Event Type
    Malfunction
    Date Received
    July 25, 2011
    Date of Event
    June 30, 2011
    Report Date
    July 25, 2011
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS HAS BEEN CONDUCTED. THE MANUFACTURING RECORDS REVIEW VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6), 2011, THE PATIENT UNDERWENT TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM WITH GORE EXCLUDER AAA ENDOPROSTHESES. WHEN THE CONTRALATERAL LEG WAS NEAR THE INTENDED TREATMENT AREA, IT DEPLOYED AUTOMATICALLY WITHOUT ANY ACTION ON THE PART OF THE PHYSICIAN. WHEN THE CATHETER WAS REMOVED, THE LEADING END HAD BROKEN OFF AND REMAINED IN THE PATIENT. THE PHYSICIAN SNARED THE WIRE AND PULLED THE CATHETER TIP OUT OF THE PATIENT WITH NO ADVERSE EVENT. THE STENT-GRAFT HAD DEPLOYED SLIGHTLY MORE PROXIMAL THAN INTENDED, BUT THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT. THE CATHETER WAS UNAVAILABLE FOR EVALUATION; IT HAD BEEN DISCARDED AT THE FACILITY.

    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 WLG425 9152302

    Patients

    Seq Age Sex Outcome Treatment
    1 FINESTERIDE| NITRODUR| AVODART| AMLODIPINE BENAZEPRIL| PLAVIX| NEXIUM| ALBUTEROL| SIMVASTATIN| FLOMAX