BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC ANEURX BIFURCATED STENT GRAFT (FLEXIBLE)

    MDR report key: 1222049 · Received November 6, 2008

    Report

    Report Number
    2953200-2008-01012
    Event Type
    Injury
    Date Received
    November 6, 2008
    Date of Event
    October 12, 2008
    Report Date
    October 13, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: RESULTS: ENDOLEAK. - PENDING DEVICE RETURNED FOR EVALUATION. CONCLUSIONS: OTHER - PENDING DEVICE RETURNED FOR EVALUATION. - RUPTURED ILIAC ARTERY.

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ANEURYSM SIZE AT THE TIME OF IMPLANT UNKNOWN. IT WAS REPORTED THE PATIENT PRESENTED 92 MONTHS POST STENT GRAFT IMPLANT WITH ABDOMINAL PAIN AND RECTAL BLEEDING. THE CT DEMONSTRATED ENLARGEMENT OF THE ANEURYSM AND THE RIGHT COMMON ILIAC ARTERY HAD RUPTURED. THE PHYSICIAN ELECTED TO SURGICALLY CONVERT THE PATIENT TO A CONVENTIONAL STENT. THE EXPLANTED STENT GRAFT IS PENDING EVALUATION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC ANEURX BIFURCATED STENT GRAFT (FLEXIBLE) MIH MEDTRONIC CARDIOVASCULAR NA M00M750254

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention