BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT II

    MDR report key: 3213799 · Received July 9, 2013

    Report

    Report Number
    2953200-2013-01284
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    June 13, 2013
    Report Date
    June 13, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: STENT GRAFT MISPLACEMENT. CALCIUM COMPRESSING THE PROXIMAL STENT RINGS AT THE TOP OF THE GATE BY THE FLOW DIVIDER. CONCLUSIONS: STENT GRAFT MISPLACEMENT. CALCIUM COMPRESSING THE PROXIMAL STENT RINGS AT THE TOP OF THE GATE BY THE FLOW DIVIDER.

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THERE WAS DIFFICULTY ADVANCING THE CONTRALATERAL LIMB. THE LIMB WAS SUCCESSFULLY DEPLOYED, BUT THE PROXIMAL END WAS APPROXIMATELY 1.5 CM BELOW THE CONTRALATERAL GATE MARKER RESULTING IN INADEQUATE OVERLAP. THE PHYSICIAN ELECTED TO IMPLANT ANOTHER MANUFACTURER¿S 10X38 COVERED STENT ON THE LEFT SIDE TO CORRECT THE ISSUE. THE FINAL ANGIOGRAM SHOWED NO EVIDENCE OF AN ENDOLEAK. THE PHYSICIAN COMMENTED THAT THE ISSUE WAS CAUSED BY CALCIUM COMPRESSING THE PROXIMAL STENT RINGS AT THE TOP OF THE GATE BY THE FLOW DIVIDER. THE PATIENT WAS DISCHARGED HOME THE DAY AFTER IMPLANT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313480 ENDURANT II SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V03994355

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention