BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT STENT GRAFT SYSTEM

    MDR report key: 2100711 · Received May 18, 2011

    Report

    Report Number
    2953200-2011-01005
    Event Type
    Injury
    Date Received
    May 18, 2011
    Date of Event
    April 19, 2011
    Report Date
    April 19, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL RESULTS AND CONCLUSION: (ENDOLEAK), (CONICAL AND SHORT AORTIC NECK).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A 5.6 CM DIAMETER ABDOMINAL AORTIC ANEURYSM. THE VESSEL MORPHOLOGY WAS REPORTED AS MILD CALCIFICATION AND MILD TORTUOSITY IN THE ILIAC LIMBS. THE AORTIC NECK IS SHORT IN LENGTH 10 MM AND CONICAL. THE AORTIC NECK DIAMETER AT THE LOWEST RENAL ARTERY IS 24 MM AND 10 MM BELOW THE LOWEST RENAL ARTERY THE AORTIC NECK DIAMETER IS 32 MM IN DIAMETER. IT WAS REPORTED THAT THE FINAL ANGIOGRAM REVEALED A PROXIMAL TYPE I ENDOLEAK FROM THE BIFURCATED STENT GRAFT(MFR REPORT# 2953200-2011-01005). THE PHYSICIAN IMPLANTED AN ENDURANT AORTIC CUFF HOWEVER, THE PROXIMAL TYPE I ENDOLEAK DID NOT COMPLETELY RESOLVE. (MFR REPORT# 2953200-2011-01006). NO ADD'L CLINICAL SEQUELAE WERE REPORTED, AND THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT STENT GRAFT SYSTEM MIH MEDTRONIC IRELAND NA V00856569

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Required Intervention