BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASSURANT COBALT

    MDR report key: 3952191 · Received July 23, 2014

    Report

    Report Number
    9612164-2014-00984
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 24, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIO
    PMA / PMN Number
    P110011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: INHERENT RISK OF PROCEDURE (STENT DISLODGED). (BASED ON THE INFORMATION AVAILABLE NO ROOT CAUSE CAN BE DETERMINED). NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED (DEVICE NOT RETURNED). EVALUATION CONCLUSION: KNOWN INHERENT RISK OF PROCEDURE (STENT DISLODGED). UNABLE TO CONFIRM COMPLAINT (DEVICE NOT RETURNED); (BASED ON THE INFORMATION AVAILABLE NO ROOT CAUSE CAN BE DETERMINED). (B)(4).

    Description of Event or Problem · 1

    DURING AN ATTEMPT TO TREAT A LESION USING THE ASSURANT COBALT DEVICE, IT WAS REPORTED THAT WHILE ADVANCING THE DEVICE TO THE TARGET LESION, THE STENT SLIPPED OFF THE BALLOON. THE PHYSICIAN REMOVED THE DEVICE AN ATTEMPTED TO ADVANCE A SECOND DEVICE AND THE STENT SLIPPED ALSO. THE POST PROCEDURE PATIENT STATUS IS REPORTED AS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431732 ASSURANT COBALT STENT, ILIAC NIO MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1