BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURXSTENT GRAFT (FLEXIBLE) WITH XPEDIENT

    MDR report key: 2003612 · Received February 22, 2011

    Report

    Report Number
    2953200-2011-00473
    Event Type
    Injury
    Date Received
    February 22, 2011
    Date of Event
    January 25, 2011
    Report Date
    January 25, 2011
    Manufacturer
    MEDTRONIC CARDIO VASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS: MIGRATION, ENDOLEAK, RUPTURE. RESULTS AND CONCLUSION: DISEASE PROGRESSION WITH AORTIC NECK DILATATION.

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROX 98 MONTHS AGO. ANEURYSM AND VESSEL MORPHOLOGY FROM THE TIME OF IMPLANT ARE UNK. AT THE TIME OF THE RECENT EVENT, THE ABDOMINAL AORTIC ANEURYSM SIZE WAS UNK; NECK WAS 32-33 MM IN DIAMETER WITH 45 DEGREE ANGULATION. IT WAS REPORTED THAT THE PT PRESENTED EMERGENTLY WITH A PROXIMAL TYPE I ENDOLEAK AND A RUPTURED AAA. THE GRAFT HAD MIGRATED DISTALLY ABOUT 2 CM. THE MIGRATION WAS ATTRIBUTED TO DISEASE PROGRESSION WITH AORTIC NECK DILATATION TO 32-33 MM IN DIAMETER, AND AORTIC NECK ANGULATION. A 36 MM TALENT CONVERTER WAS PLACED SUCCESSFULLY, FOLLOWED BY A FEM-FEM BYPASS WITHOUT ISSUES. NO ADDITIONAL CLINICAL SEQUELAE REPORTED, AND THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURXSTENT GRAFT (FLEXIBLE) WITH XPEDIENT MIH MEDTRONIC CARDIO VASCULAR NA M03E551626

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention