BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX

    MDR report key: 4221300 · Received November 3, 2014

    Report

    Report Number
    2953200-2014-02282
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    October 9, 2014
    Report Date
    October 9, 2014
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ANEURYSM AND VESSEL MORPHOLOGY AT TIME OF IMPLANT ARE UNKNOWN. CURRENTLY THE ANEURYSM IS 82 MM IN DIAMETER. IT WAS REPORTED THAT THE PATIENT RECENTLY PRESENTED TO THE HOSPITAL WITH A TENDER ABDOMEN. A NON-CONTRAST CT SHOWED THE BIFURCATED STENT MIGRATED DISTALLY 5-20 MM AND HAD NO APPOSITION IN THE AORTIC NECK. THERE WAS ALSO AN EXPANDED RIGHT COMMON ILIAC ARTERY WITH NO APPOSITION OF THE STENT GRAFT IN ILIAC ARTERY. THE MIGRATION WAS ATTRIBUTED TO DISEASE PROGRESSION. THERE WAS EVIDENCE OF A CONTAINED RUPTURE ON SCAN. IT WAS CONCLUDED THERE WAS A TYPE IA AND TYPE IB ENDOLEAK ON THE RIGHT SIDE THAT WAS ATTRIBUTED TO DISEASE PROGRESSION. THE DEVICE WAS EXTENDED TO THE RENTAL ARTERIES WITH 32 MM AND 36 MM ENDURANT CUFFS. THE DEVICE WAS EXTENDED TO THE RIGHT HYPO WITH A 16/28/124 AND A 36/70 ENDURANT STENT GRAFTS. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701058 ANEURX SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR SANTA ROSA V00252251

    Patients

    Seq Age Sex Outcome Treatment
    1 00087 YR Required Intervention