BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX XPEDIENT BIFURCATED STENT GRAFT (FLEXIBLE)

    MDR report key: 1760592 · Received July 14, 2010

    Report

    Report Number
    2953200-2010-01319
    Event Type
    Injury
    Date Received
    July 14, 2010
    Date of Event
    January 22, 2010
    Report Date
    July 1, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVAL RESULTS AND CONCLUSION: (GRAFT MIGRATION). (UNKNOWN ANEURYSM AND VESSEL MORPHOLOGY AT THE TIME OF THE MIGRATION; UNKNOWN CAUSE OF STENT GRAFT MIGRATION).

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROX 7 YEARS AGO. ANEURYSM AND VESSEL MORPHOLOGY AT THE TIME OF IMPLANT WERE NOT REPORTED. IT WAS REPORTED THAT APPROX 6 MONTHS AGO, THE ANEURX BIFURCATED STENT GRAFT WAS FOUND TO HAVE MIGRATED DUE TO AN UNK CAUSE. ANEURYSM AND VESSEL MORPHOLOGY AT THE TIME OF THE MIGRATION ALSO WERE NOT REPORTED. NO INTERVENTION WAS PERFORMED UNTIL APPROX 1 MONTH AFTER THE MIGRATION WAS IDENTIFIED. THE PHYSICIAN ELECTED TO PERFORM AN OPEN CONVERSION AND EXPLANT THE STENT GRAFT AND SEW IN A TUBE GRAFT; THE EXPLANTED STENT GRAFT WAS DISCARDED BY THE USER FACILITY. NO ADD'L CLINICAL SEQUELAE WERE REPORTED, AND THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX XPEDIENT BIFURCATED STENT GRAFT (FLEXIBLE) MIH MEDTRONIC CARDIOVASCULAR NA M02D550548

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention