BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT STENT GRAFT SYSTEM

    MDR report key: 2792630 · Received October 16, 2012

    Report

    Report Number
    2953200-2012-01954
    Event Type
    Injury
    Date Received
    October 16, 2012
    Date of Event
    September 18, 2012
    Report Date
    September 18, 2012
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: INHERENT RISK OF PROCEDURE (OCCLUSION); INCORRECT TECHNIQUE/PROCEDURE (NOT PROPERLY VISUALIZING THE HYOGASTRIC ARTERY). EVALUATION, CONCLUSION: OPERATIONAL CONTEXT CONTRIBUTED TO EVENT (NOT PROPERLY VISUALIZING THE HYOGASTRIC ARTERY).

    Description of Event or Problem · 1

    AN ENDURANT ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 4.9 CM IN DIAMETER ABDOMINAL AORTIC ANEURYSM APPROXIMATELY ONE MONTH AGO. VESSEL MORPHOLOGY WAS REPORTED AS THE PROXIMAL AORTA WAS 18.2-22.3 MM IN DIAMETER AND 32 MM IN LENGTH. THE RIGHT ILIAC ARTERY WAS 9.7-9.4-10.0 MM IN DIAMETER AND THE LEFT ILIAC ARTERY WAS 8.5-10.9-10.4 MM IN DIAMETER. THE RIGHT FEMORAL ARTERY WAS 7.8 MM IN DIAMETER AND THE LEFT FEMORAL ARTERY WAS 8.1 MM IN DIAMETER. BOTH ILIAC ARTERIES HAD CALCIFICATION. THE DISTANCE FROM THE BIFURCATION TO THE HYPOGASTRIC WAS 164.5 MM. AFTER THE BIFURCATED STENT GRAFT WAS DEPLOYED, IT WAS NOTICED THAT THE LEFT INTERNAL ILIAC ARTERY WAS UNINTENTIONALLY COVERED. THE COVERAGE WAS DUE TO INCORRECTLY IDENTIFYING THE LOCATION OF THE LEFT INTERNAL ILIAC ARTERY WITH IMAGING; THE ARTERY WAS VISUALIZED WHILE THE DELIVERY SYSTEM WAS OCCUPYING THE SAME SPACE. THE FINAL ANGIOGRAM SHOWED RAPID COLLATERALIZATION OF THE INTERNAL ILIAC ARTERY AND THEREFORE THE PHYSICIAN EXPECTS THE PATIENT TO BE NON-SYMPTOMATIC. THE PATIENT STATUS POST-PROCEDURE WAS FINE. NO CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V01076204

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR