BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX STENT GRAFT SYSTEM

    MDR report key: 2003598 · Received February 22, 2011

    Report

    Report Number
    2953200-2011-00472
    Event Type
    Injury
    Date Received
    February 22, 2011
    Date of Event
    January 23, 2011
    Report Date
    January 23, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS & CONCLUSIONS: OTHER, (LACK OF INFO PROVIDED).

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM ON AN UNK DATE. ANEURYSM AND VESSEL MORPHOLOGY FROM THE TIME OF IMPLANT AND CURRENTLY ARE UNK. IT WAS REPORTED THAT THE STENT GRAFT WAS REMOVED FROM THE PT FOR AN UNK REASON. THE STENT GRAFT WAS EXPLANTED AND THE PT WAS CONVERTED TO A CONVENTION GRAFT DURING AN OPEN SURGICAL REPAIR. NO ADDITIONAL CLINICAL SEQUELAE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention