BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2943958 · Received February 5, 2013

    Report

    Report Number
    2953200-2013-00195
    Event Type
    Injury
    Date Received
    February 5, 2013
    Date of Event
    September 21, 2009
    Report Date
    January 11, 2013
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: INHERENT RISK OF PROCEDURE (STENT GRAFT STENOSIS); PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (CALCIFIED AND TORTUOUS ILIAC ARTERIES). CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (CALCIFIED AND TORTUOUS ILIAC ARTERIES).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A FUSIFORM 4.7 CM ABDOMINAL AORTIC ANEURYSM APPROXIMATELY 40 MONTHS AGO. THE INFRA-RENAL NECK ANGLE WAS 23 DEGREES. THE AORTIC NECK DIAMETER BELOW THE LOWEST RENAL ARTERIES WAS 30 MM AND DISTALLY IT WAS 26 MM. THE DISTAL DIAMETER OF THE AORTA ANEURYSM ABOVE THE AORTIC BIFURCATION WAS 26 MM. THE RIGHT ILIAC ARTERY TORTUOSITY WAS MODERATE AND THE CALCIFICATION WAS REPORTED AS MODERATE. THE RIGHT AND LEFT STENOSIS WAS 20 PERCENT. THERE WAS A TYPE II ENDOLEAK COMING FROM A LUMBAR ARTERY POST IMPLANT. IT WAS REPORTED THAT 38 MONTHS POST IMPLANT THE MAXIMUM DIAMETER OF THE ANEURYSM WAS 4.9 CM. THE ULTRASOUND REVEALED THAT THERE WAS STENT GRAFT STENOSIS IN THE RIGHT ILIAC LIMB THAT WAS NOT PREVIOUSLY PRESENT. NO INTERVENTION WAS PERFORMED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48290 ENDURANT ABDOMINAL STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR SANTA ROSA V00342524

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR