BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASSURANT COBALT

    MDR report key: 2990928 · Received March 6, 2013

    Report

    Report Number
    9612164-2013-00247
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    January 25, 2013
    Report Date
    February 4, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIO
    PMA / PMN Number
    P110011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: INHERENT RISK OF PROCEDURE (DETACHMENT OF A COMPONENT OF THE SYSTEM). (ROOT CAUSE OF THE ISSUE IS UNDETERMINED). EVALUATION CONCLUSION: ROOT CAUSE OF THE ISSUE IS UNDETERMINED. KNOWN INHERENT RISK OF PROCEDURE (DETACHMENT OF A COMPONENT OF THE SYSTEM). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN WAS ATTEMPTING TO DEPLOY 2 (TWO) ASSURANT COBALT PERIPHERAL STENTS TO TREAT A LESION IN A PATIENT; HOWEVER, IT WAS REPORTED THAT THE STENTS DISLODGED IN A MILDLY TORTUOUS LESION AND THE STENTS WERE NOT RECOVERED FROM THE PATIENT. THE PHYSICIAN WAS ABLE TO DILATE AND STENT THROUGH AND THE PATIENT WAS REPORTED TO BE DOING WELL AFTER THE PROCEDURE. NO PATIENT INJURY AND NO OTHER CLINICAL SEQUELAE WERE REPORTED. CINE IMAGE REVIEW: ONE PROCEDURAL STILL IMAGE WAS PROVIDED FOR REVIEW. THE IMAGE CONFIRMS A DISLODGED STENT HOWEVER THE IMAGE DOES NOT PROVIDE ANY INSIGHT INTO THE ROOT CAUSE OF THE DISLODGEMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96139 ASSURANT COBALT STENT, ILIAC NIO MEDTRONIC IRELAND 0006002819

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR