BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2904843 · Received January 9, 2013

    Report

    Report Number
    2953200-2013-00040
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    November 20, 2012
    Report Date
    December 10, 2012
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: CAUSED BY ANOTHER DRUG/DEVICE (AORTIC CUFF STENT GRAFT). CONCLUSION: ANOTHER DEVICE CAUSED FAILURE (AORTIC CUFF STENT GRAFT).

    Description of Event or Problem · 1

    AN ENDURANT ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 48 MM DIAMETER ABDOMINAL AORTIC ANEURYSM APPROXIMATELY SIX WEEKS AGO. THE INFRA-RENAL NECK ANGLE WAS 55 DEGREES. THE PROXIMAL AORTA WAS 21-22 MM IN DIAMETER AND 40 MM IN LENGTH. THE RIGHT ILIAC ARTERY WAS 20 MM AND THE LEFT ILIAC ARTERY WAS 21.5 MM IN DIAMETER. THE RIGHT AND LEFT FEMORAL ARTERIES WERE 12 MM AND 8.5 MM IN DIAMETER RESPECTIVELY. IT WAS REPORTED THAT THE AORTIC CUFF WAS DEPLOYED A FEW MILLIMETERS INSIDE THE LEFT CONTRALATERAL LIMB OF THE BIFURCATED STENT GRAFT, OBSTRUCTING BLOOD FLOW TO THE RIGHT IPSILATERAL LIMB. THIS WAS DUE TO A SIZING ERROR BY THE PHYSICIAN (SELECTING A CUFF THAT WAS TOO LONG FOR THE PROXIMAL AORTIC NECK). A SUPRA PUBIC BYPASS WAS PERFORMED TO RESTORE BLOOD FLOW. THE SUBJECT IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12900 ENDURANT ABDOMINAL STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V01709921

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR Required Intervention