BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASSURANT COBALT

    MDR report key: 4823387 · Received June 8, 2015

    Report

    Report Number
    9612164-2015-00906
    Event Type
    Injury
    Date Received
    June 8, 2015
    Date of Event
    May 6, 2015
    Report Date
    May 13, 2015
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIO
    PMA / PMN Number
    P110011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: INHERENT RISK OF PROCEDURE (STENT EMBOLISM); PATIENT CONDITION AFFECTED EFFECTIVENESS OF DEVICE (ECCENTRIC FOCAL LESION WHICH WAS APPROXIMATELY 80%); NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED - DEVICE OR PROCEDURAL IMAGES NOT PROVIDED FOR REVIEW; DEVICE NOT RETURNED FOR EVALUATION. CONCLUSION: INHERENT RISK OF PROCEDURE ¿ (STENT EMBOLISM); DEVICE FAILURE RELATED TO PATIENT CONDITION (ECCENTRIC FOCAL LESION WHICH WAS APPROXIMATELY 80%); UNABLE TO CONFIRM COMPLAINT (DEVICE OR PROCEDURAL IMAGES NOT PROVIDED FOR REVIEW). (B)(4).

    Description of Event or Problem · 1

    ASSURANT COBALT PERIPHERAL STENT WAS BEING USED TO TREAT A LESION IN THE EXTERNAL ILIAC. THE GRADIENT ACROSS THE ILIAC ARTERY WAS 40MM. AT THE JUNCTION OF THE COMMON ILIAC AND EXTERNAL ILIAC THERE WAS AN ECCENTRIC FOCAL LESION WHICH WAS APPROXIMATELY 80%. DEVICE WAS REMOVED FROM PACKAGING PER IFU, INSPECTED AND PREPPED WITH NO ISSUES NOTED. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE BUT IT IS UNKNOWN IF EXCESSIVE FORCE WAS USED. DEVICE DID NOT USE THROUGH A PREVIOUSLY DEPLOYED STENT. IT IS REPORTED THAT THE STENT DISLODGED FROM THE BALLOON WHEN ADVANCING TO THE LESION. NO ATTEMPTS WERE MADE TO REMOVE THE DISLODGED STENT. THE STENT HAD TO BE IMPLANTED IN THE COMMON ILIAC INSTEAD OF THE EXTERNAL ILIAC. THE STENT WAS CRIMPED AND A 8 MM BALLOON WAS USED TO EXPAND THE STENT FOLLOWED BY A 9X40 BALLOON EXPANDABLE STENT TO COVER EXTERNAL ILIAC LESION. THE STENT EXTENDED INTO THE CRIMPED STENT IN THE COMMON ILIAC. THE STENT WAS BALLOONED TO 8ATM AND THE RESULT WAS 0% RESIDUAL STENOSIS. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367246 ASSURANT COBALT STENT, ILIAC NIO MEDTRONIC IRELAND 0007405867

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention