BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASSURANT COBALT

    MDR report key: 3120001 · Received May 20, 2013

    Report

    Report Number
    9612164-2013-00549
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    April 22, 2013
    Report Date
    April 22, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIO
    PMA / PMN Number
    P110011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION, RESULTS: INHERENT RISK OF PROCEDURE (STENT EMBOLISM IS LISTED IN THE PRODUCT IFU AS AN INHERENT RISK OF STENTING PROCEDURES.); RELATED TO OPERATIONAL CONTEXT (REPORTED EVENT WAS MOST LIKELY PROCEDURAL RELATED); NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED (DEVICE OR PROCEDURAL IMAGES NOT PROVIDED FOR REVIEW). CONCLUSION: KNOWN INHERENT RISK OF PROCEDURE (STENT EMBOLISM IS LISTED IN THE PRODUCT IFU AS AN INHERENT RISK OF STENTING PROCEDURES.); OPERATIONAL CONTEXT CONTRIBUTED TO THE EVENT (REPORTED EVENT WAS MOST LIKELY PROCEDURAL RELATED); UNABLE TO CONFIRM COMPLAINT (DEVICE OR PROCEDURAL IMAGES NOT PROVIDED FOR REVIEW). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN WAS ATTEMPTING TO DEPLOY AN ASSURANT COBALT BALLOON-EXPANDABLE PERIPHERAL STENT TO TREAT A LESION IN A PATIENT LOCATED IN THE ILIAC. IT WAS REPORTED THAT A GUIDEWIRE USED IN THE PROCEDURE CAUSED A DISSECTION IN THE LCIA AND THE WIRE ENTERED THE SUB-INTIMAL SPACE. THIS WAS NOT KNOWN BY THE PHYSICIAN, AND HE PROCEEDED STENTING OF THE LCIA AND ADVANCED THE STENT INTO THE DISSECTED SUB-INTIMAL LAYER IN THE LCIA. ONCE IT WAS REALISED THAT THIS OCCURRED, THE PHYSICIAN ATTEMPTED TO WITHDRAW THE STENT, HOWEVER, THE STENT CAME OFF THE BALLOON AT THIS POINT. AFTER ATTEMPTING TO CANNULATE THE STENT, THE PHYSICIAN THEN MADE A RETROGRADE STICK, AND STENTED OVER THE ASSURANT COBALT STENT AND CRUSHED THE STENT IN THE SUB-INTIMAL LAYER. THE PATIENT DID WELL DURING THE PROCEDURE AND NO OTHER CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221369 ASSURANT COBALT STENT, ILIAC NIO MEDTRONIC IRELAND 0006677328

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention