BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2010766 · Received March 2, 2011

    Report

    Report Number
    2953200-2011-00578
    Event Type
    Injury
    Date Received
    March 2, 2011
    Date of Event
    January 31, 2011
    Report Date
    January 31, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS: MIGRATION, ENDOLEAK. DISEASE PROGRESSION OF THE AORTIC NECK. EVALUATION CONCLUSION: DISEASE PROGRESSION OF THE AORTIC NECK.

    Description of Event or Problem · 1

    AN ANEURX ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROXIMATELY 20 MONTHS AGO. ANEURYSM AND VESSEL MORPHOLOGY FROM THE TIME OF IMPLANT ARE UNKNOWN. THE PATIENT PRESENTED WITH SEVERE PERIPHERAL VASCULAR DISEASE AND DURING THIS SURVEILLANCE HE WAS FOUND TO HAVE RENAL ARTERY STENOSIS, SUPERFICIAL FEMORAL ARTERY DISEASE BILATERALLY AND A POPLITEAL ARTERY ANEURYSM ON THE RIGHT. NINE MONTHS AGO A CT SCAN OF THE ABDOMEN SHOWED THAT THE ABDOMINAL AORTA AT THE LEVEL OF THE RENALS WAS 3.2 CM (PREVIOUSLY MEASURING 3.4 CM) IN DIAMETER. THE MID-INFRARENAL ABDOMINAL AORTA DIAMETER WAS 5.0 X 5.2 CM (PREVIOUSLY 4.9 X 5.2 CM) AND THE DISTAL INFRARENAL ABDOMINAL AORTA DIAMETER WAS 4.5 X 5.2 CM (PREVIOUSLY 4.7 X 5.3 CM). THE DISTAL RIGHT COMMON ILIAC ARTERY DIAMETER WAS 1.6 CM (PREVIOUSLY 1.5 CM). IT WAS REPORTED THAT THE PATIENT HAS VIRTUALLY NO AORTIC NECK CURRENTLY. THE PROXIMAL PORTION OF THE DEVICE IS 4 CM BELOW THE RENALS. THERE IS NO SEAL ZONE IN WHICH TO PLACE AN AORTIC CUFF. THE PATIENT IS SCHEDULED FOR AN ENDOVASCULAR PROCEDURE IN 9 DAYS THE TYPE OF WHICH IS TO BE DETERMINED IN THE UPCOMING DAYS. NO ADDITIONAL CLINICAL SEQUELAE REPORTED, AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX ABDOMINAL STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR NA 460537

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention