BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT II

    MDR report key: 3841741 · Received May 30, 2014

    Report

    Report Number
    2953200-2014-01103
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 5, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, CONCLUSION: FAILURE TO FOLLOW INSTRUCTIONS (NOT HAVING ADEQUATE VISUAL ACCESS).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM CONSISTING OF AN WAS IMPLANTED INTO A PATIENT FOR THE TREATMENT OF A 6.5 CM IN DIAMETER ABDOMINAL AORTIC ANEURYSM. VESSEL MORPHOLOGY WAS REPORTED AS THE AORTIC NECK IS 23-25 MM IN DIAMETER, THE LENGTH IS 15 MM, AND MILD CALCIFICATION OR TORTUOSITY. IT WAS REPORTED THAT THE PHYSICIAN INADVERTENTLY IMPLANTED THE BIFURCATED STENT GRAFT LOWER THEN INTENDED DUE TO EXACT LOCATION OF RENAL ARTERY TAKE OFF WAS UNABLE TO BE IDENTIFIED WITH X-RAY EQUIPMENT. THERE IS A PROXIMAL TYPE I ENDOLEAK PRESENT. THE PHYSICIAN IMPLANTED AN ENDURANT AORTIC CUFF 32X32X49 WAS IMPLANTED AT THE RIGHT RENAL ARTERY, THE PROXIMAL TYPE I ENDOLEAK WAS RESOLVED HOWEVER THE AORTIC CUFF WAS PARTIALLY COVERING THE RENAL ARTERY. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE. THE REVIEW OF PRE-IMPLANT FILMS REVEALED THAT THE PROXIMAL NECK WAS ANGULATED APPROXIMATELY 40 DEGREE MAX, 24MM IN DIAMETER, WITH LITTLE CALCIFICATION. THE MAXIMUM DIAMETER AAA MEASURED 6.7CM, AND CONTAINED THROMBUS (3.5MAX DIAMETER FLOW LUMEN). THE ILIACS WERE MILDLY TORTUOUS WITH MINIMAL CALCIFICATION. IMAGES DURING IMPLANT WERE NOT PROVIDED. THERE WERE NO SIGNIFICANT ANATOMICAL ISSUES SEEN PRE-IMPLANT WHICH MAY HAVE CONTRIBUTED TO THE REPORTED TYPE IA ENDOLEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319519 ENDURANT II SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04243088

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Required Intervention