BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT II ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2951141 · Received February 8, 2013

    Report

    Report Number
    2953200-2013-00232
    Event Type
    Injury
    Date Received
    February 8, 2013
    Date of Event
    January 16, 2013
    Report Date
    January 16, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) RESULTS: INHERENT RISK OF PROCEDURE (VESSEL OCCLUSION); INCORRECT TECHNIQUE/PROCEDURE (STENT GRAFT WAS INACCURATELY DELIVERED AND OCCLUDED A RENAL ARTERY). CONCLUSION: USER ERROR CONTRIBUTED TO EVENT (STENT GRAFT WAS INACCURATELY DELIVERED AND OCCLUDED A RENAL ARTERY).

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROXIMATELY SEVEN YEARS AGO. ANEURYSM AND VESSEL MORPHOLOGY FROM THE TIME OF IMPLANT ARE UNKNOWN. IT WAS REPORTED THAT DURING A ROUTINE FOLLOW UP CT SCAN A PROXIMAL TYPE I ENDOLEAK WAS PRESENT. THE STENT GRAFT HAD MIGRATED 9 MM AND THE ANEURYSM MEASURED 58 MM IN DIAMETER. THE PHYSICIAN DECIDED TO IMPLANT AN ENDURANT AORTIC CUFF (B)(4) AND THIS SUCCESSFULLY RESOLVED THE PROXIMAL TYPE I ENDOLEAK; HOWEVER, THE LEFT RENAL ARTERY WAS UNINTENTIONALLY PARTIALLY OCCLUDED. THE PHYSICIAN DECIDED TO STENT THE LEFT RENAL ARTERY AND RESTORED BLOOD FLOW. THE PHYSICIAN ALSO ELECTED TO EXTEND THE LEFT ILIAC ARTERY WITH ANOTHER MANUFACTURER'S STENT GRAFT. THE CAUSE OF THE MIGRATION WAS LIKELY RELATED TO DISEASE PROGRESSION DUE TO NECK DILATATION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53850 ENDURANT II ABDOMINAL STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V01714133

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention