BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX XPEDIENT BIFURCATED STENT GRAFT (FLEXIBLE)

    MDR report key: 2133505 · Received June 15, 2011

    Report

    Report Number
    2953200-2011-01149
    Event Type
    Injury
    Date Received
    June 15, 2011
    Date of Event
    May 18, 2011
    Report Date
    May 18, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS: ENDOLEAK. RESULTS/CONCLUSIONS: UNKNOWN CAUSE OF TYPE III ENDOLEAK.

    Description of Event or Problem · 1

    AN ANEURX ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROXIMATELY 8 YEARS AGO. ANEURYSM AND VESSEL MORPHOLOGY AT THE TIME OF IMPLANT WERE NOT REPORTED. IT WAS REPORTED THAT A RECENT ANGIOGRAM DEMONSTRATED A TYPE III ENDOLEAK, (FABRIC) IN THE ANEURX IPSILATERAL LIMB WHERE THE LIMB AND AN EXTENSION OVERLAP. THE PHYSICIAN IMPLANTED AN ENDURANT EXTENSION TO RELINE THE IPSILATERAL AND THE ENDOLEAK WAS RESOLVED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX XPEDIENT BIFURCATED STENT GRAFT (FLEXIBLE) MIH MEDTRONIC CARDIOVASCULAR NA M03L550145

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention