BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2210586 · Received August 10, 2011

    Report

    Report Number
    2953200-2011-01419
    Event Type
    Injury
    Date Received
    August 10, 2011
    Date of Event
    July 25, 2011
    Report Date
    July 25, 2011
    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: CONVERSION TO OPEN REPAIR. RESULTS/CONCLUSIONS: TYPE II ENDOLEAK.

    Description of Event or Problem · 1

    AN ANEURX ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A 5.1 CM DIAMETER ABDOMINAL AORTIC ANEURYSM APPROXIMATELY 55 MONTHS AGO. VESSEL MORPHOLOGY FROM THE TIME OF IMPLANT IS UNK. IT WAS REPORTED THAT THE PT WAS BEING FOLLOWED FOR A PERSISTENT VERTEBRAL TYPE II ENDOLEAK. APPROXIMATELY 11 MONTHS AGO, THE ANEURYSM HAD GROWN TO 6 CM AND APPROXIMATELY 1 MONTH AGO, THE ANEURYSM WAS 6.3 CM. THE PHYSICIAN DID NOT ATTEMPT TO COIL THE TYPE II ENDOLEAK AND ELECTED TO EXPLANT THE STENT GRAFT AND SUCCESSFULLY SEWED IN A DACRON GRAFT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PT IS FINE. THE EXPLANTED STENT GRAFT HAS BEEN RECEIVED BY MEDTRONIC AND THE ANALYSIS IS PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX ABDOMINAL STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR NA 482709

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention