BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLITAIRE FR

    MDR report key: 3863995 · Received June 10, 2014

    Report

    Report Number
    2029214-2014-00327
    Event Type
    Injury
    Date Received
    June 10, 2014
    Report Date
    May 12, 2014
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    NRY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION AS IT REMAINS IN THE PATIENT. (B)(4).

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM THE ARTICLE: GASCOU G, LOBOTESIS K, MACHI P, MALDONADO I, VENDRELL, JF, RIQUELME O, ET AL. STENT RETREIVERS IN ACUTE ISCHEMIC STROKE: COMPLICATIONS AND FAILURES DURING THE PERIOPERATIVE PERIOD. AM J NEURORADIOL. APR 2014; 35: 734-40. ON (B)(6) 2014, A LITERATURE ARTICLE WAS RECEIVED DESCRIBING A TOTAL OF 144 PATIENTS WITH A MEAN AGE OF 67 YEARS (74 MEN / 70 WOMEN) WHO UNDERWENT MECHANICAL THROMBECTOMY (WITH OPTIONAL ANGIOPLASTY). OUT OF THE 144 PATIENTS, 138 WERE TREATED WITH THE SOLITAIRE FR DEVICE. OUT OF THE NUMBER OF PATIENTS THAT WERE TREATED WITH THE SOLITAIRE FR, DEVICE FRACTURE AND SPONTANEOUS RELEASE OF THE STENT WERE SEEN IN TWO PATIENTS. THE DEVICES WERE LEFT INSIDE BOTH PATIENTS AND THEY ALSO RECEIVED A LONG TERM ANTIPLATELET THERAPY WITH A GOOD NEUROLOGICAL OUTCOME AT DISCHARGE. SAME EVENT AS MDR# 2029214-2014-00326.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339138 SOLITAIRE FR FLOW RESTORATION NRY EV3 NEUROVASCULAR NOT REPORTED NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability