BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT STENT GRAFT SYSTEM

    MDR report key: 2801933 · Received October 23, 2012

    Report

    Report Number
    2953200-2012-02021
    Event Type
    Injury
    Date Received
    October 23, 2012
    Date of Event
    July 28, 2013
    Report Date
    September 19, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, METHOD: (FILMS). EVALUATION, RESULTS: INHERENT RISK OF PROCEDURE (OCCLUSION); (UNKNOWN CAUSE OF EVENT). EVALUATION, CONCLUSION: (UNKNOWN CAUSE OF EVENT).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE PATIENT PRESENTED WITH PULMONARY COMPLICATION DUE TO COPD EXACERBATION. THE DEVICE AND PROCEDURE RELATION IS UNKNOWN. THE PATIENT STATUS IS UNKNOWN.

    Description of Event or Problem · 1

    AN ENDURANT ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. A 5.2 CM FUSIFORM ANEURYSM WAS REPORTED WITH AN INFRA-RENAL ANGLE OF 15 DEGREES. PROXIMAL AORTA WAS 21 MM IN DIAMETER AND 36 MM IN LENGTH. DISTAL AORTA WAS 30 MM IN DIAMETER. RIGHT ILIAC ARTERY WAS 10 MM IN DIAMETER AND THE LEFT ILIAC ARTERY WAS 22 MM IN DIAMETER. THE RIGHT AND LEFT FEMORAL ARTERIES WERE 7 AND 6 MM IN DIAMETER, RESPECTIVELY. THE RIGHT ILIAC ARTERY WAS MILDLY TORTUOUS WITH NO STENOSIS AND THE LEFT ILIAC ARTERY WAS MODERATELY TORTUOUS WITH NO STENOSIS. THE CIRCUMFERENTIAL AORTA HAD NO MURAL THROMBUS/CALCIFICATION. THE PROXIMAL END OF THE GRAFT WAS PLACE SUCH THAT THE SUPRARENAL STENTS WERE CROSSING BOTH RENAL ARTERIES. THE DISTAL END OF THE RIGHT LIMB WAS PLACED PROXIMALLY TO THE RIGHT INTERNAL ILIAC ARTERY WHILE THE DISTAL END OF THE LEFT EXTENSION WAS PLACED DISTALLY TO THE LEFT INTERNAL ILIAC ARTERY. A FOX CROSS, BALLOON WAS USED. AFTER THE STENT GRAFTS WERE PLACED, A SMALL DISSECTION WAS DISCOVERED IN THE LEFT EXTERNAL ILIAC ARTERY AND WAS REPAIRED WITH AN ABSOLUTE PRO SELF-EXPANDING STENT IN THE ARTERY. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE. FILMS WERE RECEIVED AND THEIR EVALUATION WAS COMPLETED. THE REVIEW OF RETURNED FILMS POST IMPLANT SHOW THAT THE IPSILATERAL AND IPSILATERAL EXTENSION WERE ON THE RIGHT, AND THE CONTRA, CONTRA EXTENSION, AND A DISTAL STENT WERE ON THE LEFT SIDE. THE BIFURCATE IS OCCLUDED WITHIN THE AORTIC BODY, AND DISTALLY WITHIN THE ENTIRE IPSILATERAL LIMB AND IPSILATERAL EXTENSION. NO OBVIOUS STENT GRAFT KINK OR COMPRESSION WAS OBSERVED. POST-TREATMENT SHOWS THE OCCLUSION HAS RESOLVED. THE CAUSE OF THE OCCLUSION COULD NOT BE DETERMINED FROM THESE ANGIOGRAM IMAGES.

    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 V01015782

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Required Intervention