BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT BIFURCATED STENT GRAFT

    MDR report key: 2801392 · Received October 23, 2012

    Report

    Report Number
    2953200-2012-02013
    Event Type
    Injury
    Date Received
    October 23, 2012
    Date of Event
    September 24, 2012
    Report Date
    September 24, 2012
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: INHERENT RISK OF PROCEDURE (RUPTURE); CAUSED BY ANOTHER DRUG/DEVICE (16 FR SHEATH CONTRIBUTED TO THE RUPTURE). EVALUATION, CONCLUSION: ANOTHER DEVICE CAUSED FAILURE (16 FR SHEATH CONTRIBUTED TO THE RUPTURE).

    Description of Event or Problem · 1

    AN ENDURANT ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 5.2 CM DIAMETER ABDOMINAL AORTIC ANEURYSM AND A 2.1 CM IN DIAMETER RIGHT COMMON ILIAC ARTERY ANEURYSM. THE REMAINDER OF THE VESSEL MORPHOLOGY WAS UNREMARKABLE. THE BIFURCATED STENT GRAFT WAS SUCCESSFULLY IMPLANTED. WHILE ATTEMPTING TO CANNULATE THE CONTRALATERAL GATE, A 16 FR SHEATH THAT WAS ALREADY IN THE PATIENT RUPTURED THE RIGHT COMMON ILIAC ANEURYSM. A RELIANT BALLOON WAS INFLATED IN THE INFRA-RENAL AORTA AND GATE CANNULATION WAS SUCCESSFULLY PERFORMED. THE CONTRALATERAL LIMB WAS PLACED BEYOND THE LEVEL OF PERFORATION AND THE RUPTURE WAS EXCLUDED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 00084 YR Required Intervention