BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASSURANT COBALT

    MDR report key: 2895964 · Received January 4, 2013

    Report

    Report Number
    9612164-2013-00019
    Event Type
    Malfunction
    Date Received
    January 4, 2013
    Date of Event
    December 10, 2012
    Report Date
    December 10, 2012
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIO
    PMA / PMN Number
    P110011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: INHERENT RISK OF PROCEDURE (STENT DISLODGEMENT). RELATED TO OPERATIONAL CONTEXT (ROOT CAUSE OF ISSUE MOST LIKELY PROCEDURAL RELATED). NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED (DEVICE NOT PROVIDED FOR REVIEW). EVALUATION CONCLUSION: RELATED TO OPERATIONAL CONTEXT (ROOT CAUSE OF ISSUE MOST LIKELY PROCEDURAL RELATED). KNOWN INHERENT RISK OF PROCEDURE (STENT DISLODGEMENT). UNABLE TO CONFIRM COMPLAINT (DEVICE OR PROCEDURAL IMAGES NOT PROVIDED FOR REVIEW). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO DEPLOY AN ASSURANT COBALT PERIPHERAL STENT INTO A PATIENT TO TREAT A LESION IN THE COMMON ILIAC WITH MODERATE TORTUOSITY. IT WAS REPORTED THAT THE STENT WAS ADVANCED INTO THE DISTAL EDGE OF A PREVIOUSLY DEPLOYED ENDURANT II LIMB AND BECAME STUCK. WHEN AN ATTEMPT WAS MADE TO PULL THE STENT OUT, THE STENT GOT STUCK ON THE EDGE OF THE ENDURANT LIMB AND DISLODGED FROM THE BALLOON. THEY WERE ABLE TO ADVANCE THE BALLOON BACK IN AND CATCH THE STENT. AFTER SEVERAL ATTEMPTS, THEY WERE ABLE TO GET THE STENT AND BALLOON INTO PLACE AND PROPERLY EXPAND IT. NO PATIENT INJURY OCCURRED AND NO CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5287 ASSURANT COBALT STENT, ILIAC NIO MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR