BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT STENT GRAFT SYSTEM

    MDR report key: 2821653 · Received November 6, 2012

    Report

    Report Number
    2953200-2012-02133
    Event Type
    Injury
    Date Received
    November 6, 2012
    Date of Event
    October 11, 2012
    Report Date
    October 11, 2012
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: INHERENT RISK OF PROCEDURE (ENDOLEAK). RELATED TO OPERATIONAL CONTEXT (DEVICE UNDER SIZING). CONCLUSION: OPERATIONAL CONTEXT CONTRIBUTED TO EVENT (DEVICE UNDER SIZING).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF 6.4 CM IN DIAMETER ABDOMINAL AORTIC ANEURYSM. THE PROXIMAL AORTIC NECK WAS 27-29 MM IN DIAMETER AND 24 MM IN LENGTH. THE PHYSICIAN USED THE RIGHT FEMORAL ARTERY AS AN ACCESS ROUTE AND COVERED THE RIGHT RENAL ARTERY TO FIT THE DISTAL END OF THE STENT GRAFT TO THE END OF THE EXTERNAL ILIAC ARTERY. AFTER THE BIFURCATED STENT GRAFT WAS IMPLANTED, A SMALL PROXIMAL TYPE I ENDOLEAK WAS OBSERVED ON THE FINAL ANGIOGRAM. THE PHYSICIAN COMMENTED THAT THE ENDOLEAKS WILL RESOLVE BECAUSE IT WAS A SMALL AMOUNT. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    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 V01139488

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR