BEUDAMED
    FDA Adverse Event Injury Summary report: N

    212525-LVIS-C-HDE

    MDR report key: 5951368 · Received September 14, 2016

    Report

    Report Number
    2032493-2016-00214
    Event Type
    Injury
    Date Received
    September 14, 2016
    Date of Event
    July 17, 2016
    Report Date
    August 19, 2016
    Manufacturer
    MICROVENTION, INC.
    Product Code
    NJE
    PMA / PMN Number
    H130005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THIS INCIDENT WAS NOT RETURNED FOR EVALUATION. IT IS UNKNOWN IF THE DEVICE WAS REPORTED TO BE A CONTRIBUTING FACTOR. (B)(4).

    Description of Event or Problem · 1

    PATIENT HAD UNDERGONE PRIOR STENT SUPPORTED COIL EMBOLIZATION OF THE ANEURYSM ON (B)(6) 2015. A RECENT FOLLOW-UP CEREBRAL ANGIOGRAM HAD SHOWN RECANALIZATION OF THE ANEURYSM SECONDARY TO COIL COMPACTION. ON (B)(6) 2016, DURING THE SECOND ANEURYSM COILING. THE PATIENT SUFFERED AN ACUTE IN-STENT THROMBOSIS, REQUIRING IV INTEGRILIN AND ASPIRATION THROMBECTOMY BUT WITH NO RESIDUAL ANGIOGRAPHIC CLOT, NEUROLOGICAL DEFICIT, OR STROKE BY CT. RECOMMENDATION OF DUAL ANTIPLATELET THERAPY WITH ASPIRIN AND BRILLINTA. POSTOPERATIVE NEUROLOGICAL AND HEMODYNAMIC MONITORING WAS ALSO RECOMMENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600297 212525-LVIS-C-HDE INTRALUMINAL STENT NJE MICROVENTION, INC. 212525-LVIS-C-HDE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| O| S