BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC ANEURX BIFURCATED STENT GRAFT (FLEXIBLE)

    MDR report key: 1843367 · Received September 22, 2010

    Report

    Report Number
    2953200-2010-01803
    Event Type
    Malfunction
    Date Received
    September 22, 2010
    Date of Event
    August 26, 2010
    Report Date
    August 26, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, (RESULTS, CONCLUSION) - OTHER: LACK OF INFORMATION (ANEURYSM AND VESSEL MORPHOLOGY ARE UNKNOWN, UNKNOWN CAUSE OF FRACTURE).

    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 8 YEARS AGO. ANEURYSM AND VESSEL MORPHOLOGY AT THE TIME OF IMPLANT WERE NOT REPORTED. IT WAS REPORTED THAT THE PATIENT RETURNED FOR A ROUTINE FOLLOW-UP, AND A TYPE 3 ENDOLEAK (FABRIC TEAR) WAS NOTED IN THE MIDDLE OF THE CONTRALATERAL/LEFT LIMB CLOSE TO THE PROXIMAL EDGE OF AN EXTENSION CUFF ON THAT SIDE (SEE MFR # 2953200-2010-01802). IT IS SUSPECTED THAT THE CUFF MAY HAVE CONTRIBUTED TO THE FABRIC TEAR. THE CONTRALATERAL LIMB WAS RELINED WITH AN ILIAC LIMB TO RESOLVE THE TYPE 3 ENDOLEAK. ADDITIONALLY, THERE WAS A SUSPECTED, BUT UNCONFIRMED STENT FRACTURE IN THE IPSILATERAL LIMB OF THE MAIN BODY. NO INTERVENTION WAS PERFORMED. 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 M01J750013

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR