BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASSURANT COBALT

    MDR report key: 3160800 · Received June 11, 2013

    Report

    Report Number
    9612164-2013-00630
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    May 15, 2013
    Report Date
    May 15, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIO
    PMA / PMN Number
    P110011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS: (INHERENT RISK OF PROCEDURE) ¿ DETACHMENT OF A COMPONENT OF THE SYSTEM (STENT DISLODGED). (LESION MORPHOLOGY). TORTUOSITY AND STENOSIS HAS MOST LIKELY CONTRIBUTED TO THE STENT DISLODGEMENT. (NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED) ¿ DEVICE OR PROCEDURAL IMAGES NOT PROVIDED FOR REVIEW. DEVICE NOT RETURNED FOR EVALUATION. (INHERENT RISK OF PROCEDURE) ¿ DETACHMENT OF A COMPONENT OF THE SYSTEM (STENT DISLODGED). (LESION MORPHOLOGY) ¿ TORTUOSITY AND STENOSIS HAS MOST LIKELY CONTRIBUTED TO THE STENT DISLODGEMENT. (UNABLE TO CONFIRM COMPLAINT) ¿ DEVICE OR PROCEDURAL IMAGES NOT PROVIDED FOR REVIEW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO TREAT A LESION SITUATED IN THE RIGHT EXTERNAL ILIAC WHICH EXHIBITED 80% STENOSIS AND NO CALCIFICATION WITH AN COBALT ASSURANT STENT. IT WAS REPORTED THAT, WHILE DOING A CONTRA LATERAL PROCEDURE AND TRYING TO LAND IT IN THE BIFURCATION THE STENT CAME OFF THE BALLOON. THE STENT HAD TO BE PULLED BACK TO THE OTHER ILIAC AND THE STENT WAS DEPLOYED THERE IN AN UN-DISEASED ILIAC ARTERY. NEGATIVE PREP WAS PERFORMED ON THE DEVICE WITH NO ISSUE REPORTED. NO PATIENT INJURY OR CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262728 ASSURANT COBALT STENT, ILIAC NIO MEDTRONIC IRELAND 0005841335

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention