BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASSURANT COBALT

    MDR report key: 3042080 · Received April 9, 2013

    Report

    Report Number
    9612164-2013-00382
    Event Type
    Injury
    Date Received
    April 9, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 11, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIO
    PMA / PMN Number
    P110011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS: INHERENT RISK OF PROCEDURE- STENT DISLODGEMENT. PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (80% STENOSIS, EXCESSIVE TORTUOSITY AND SEVERE CALCIFICATION). DEFORMATION PROBLEM (ADVANCEMENT THROUGH LESION). EVALUATION CONCLUSION: KNOWN INHERENT RISK OF PROCEDURE (STENT DISLODGEMENT). DEVICE FAILURE RELATED TO PATIENT CONDITION (80% STENOSIS, EXCESSIVE TORTUOSITY AND SEVERE CALCIFICATION).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN WAS ATTEMPTING TO DEPLOY AN 8MM DIAMETER X 60MM LENGTH ASSURANT COBALT PERIPHERAL STENT TO TREAT A LESION IN THE LEFT COMMON ILIAC ARTERY WITH 80% STENOSIS, EXCESSIVE TORTUOSITY AND SEVERE CALCIFICATION. IT WAS REPORTED THAT THE LESION WAS PRE-DILATED AND THAT RESISTANCE WAS NOTED WHILE CROSSING THE LESION. IT WAS NOTED THAT THE STENT DISLODGED FROM THE DELIVERY CATHETER IN THE VESSEL OF THE COMMON ILIAC AFTER THE VESSEL WAS PRE-DILATED. THE STENT WAS RETRIEVED VIA OPEN SURGERY AND ANOTHER STENT WAS USED TO COMPLETE THE PROCEDURE. NO OTHER CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145179 ASSURANT COBALT STENT, ILIAC NIO MEDTRONIC IRELAND 0005785396

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention