BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 2211413 · Received August 8, 2011

    Report

    Report Number
    2017233-2011-00402
    Event Type
    Injury
    Date Received
    August 8, 2011
    Date of Event
    April 26, 2011
    Report Date
    August 5, 2011
    Manufacturer
    W. L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MFG PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MFG PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECS. PLEASE NOTE ADD'L DEVICES IMPLANTED: (B)(4), (B)(4), (B)(4), AND (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2006, THE PT WAS IMPLANTED WITH GORE EXCLUDER AAA ENDOPROSTHESES TO TREAT AN INFRARENAL AORTIC ANEURYSM. ON (B)(6) 2011, CT SHOWED A TYPE II ENDOLEAK AND AN ANEURYSM MEASUREMENT OF 6.6 CM COMPARED TO A PREVIOUS STUDY OF 5.5 CM. ON (B)(6) 2011, THE PT UNDERWENT AN EXPLANT OF THE ENDOGRAFT SYSTEM.

    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 04530776

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Hospitalization| R FINASTERILDE| ARIXTRA| SIMVASTATIN| DULCOLAX| DILTIAZEM| ADVAIR| LOSARTAN| TAPENTADOL| PLAVIX| ASPIRIN| TYLENOL| LACTULOSE| NITROGLYCERIN| SPIRIVA| OMEPRAZOLE