BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX STENT GRAFT WITH XCELERANT DELIVERY SYSTEM

    MDR report key: 1924455 · Received December 7, 2010

    Report

    Report Number
    2953200-2010-02444
    Event Type
    Injury
    Date Received
    December 7, 2010
    Date of Event
    November 8, 2010
    Report Date
    November 9, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS: (DISEASE PROGRESSION), (ANEURYSM RUPTURE). EVAL, CONCLUSION: (DISEASE PROGRESSION).

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROX 67 MONTHS AGO. ANEURYSM AND VESSEL MORPHOLOGY AT THE TIME OF IMPLANT WERE NOT REPORTED. THE PT HAS NOT RETURNED FOR REGULAR FOLLOW UPS SINCE 2008. IT WAS REPORTED THAT THE PT RETURNED WITH AN EMERGENT ANEURYSM RUPTURE APPROX 1 MONTH AGO. THE PHYSICIAN COMMENTED THAT THE RUPTURE MAY HAVE BEEN DUE TO DISEASE PROGRESSION; HOWEVER, THIS WAS NOT CONFIRMED. THE PT WAS CONVERTED TO A SUCCESSFUL OPEN REPAIR WITH EXPLANT OF THE STENT GRAFT. NO ADD'L CLINICAL SEQUELAE WERE REPORTED, AND THE PT IS FINE. THE EXPLANTED GRAFT WAS DISCARDED BY THE USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX STENT GRAFT WITH XCELERANT DELIVERY SYSTEM MIH MEDTRONIC CARDIOVASCULAR NA 387676

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention