BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLITAIRE REVASCULARIZATION DEVICE

    MDR report key: 4815882 · Received June 3, 2015

    Report

    Report Number
    2029214-2015-00621
    Event Type
    Injury
    Date Received
    June 3, 2015
    Date of Event
    November 13, 2012
    Report Date
    May 8, 2015
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    NRY
    PMA / PMN Number
    K113455
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT WAS CREATED TO CAPTURE THE COMPLICATIONS REPORTED IN THE ARTICLE AND CAN BE FOUND ONLINE (B)(4). THE DEVICES INVOLVED IN THE EVENT WERE NOT RETURNED FOR EVALUATION. THERE HAS BEEN NO CORRESPONDENCE REGARDING RETURN OF THE DEVICE. THE LOT HISTORY RECORD REVIEW WAS NOT POSSIBLE AS THE LOT NUMBERS WERE NOT REPORTED. (B)(4).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THROUGH LITERATURE REVIEW OF "SUBARACHNOID HEMORRHAGE IN A MULTIMODAL APPROACH HEAVILY WEIGHTED TOWARD MECHANICAL THROMBECTOMY WITH SOLITAIRE STENT IN ACUTE STROKE¿ YOON W. JUNG MY. JUNG SH. IT WAS REPORTED THAT 12 PATIENTS EXHIBITED A NEW HYPERDENSE LESION WITHIN THE SUBARACHNOID SPACE ON THE IMMEDIATE POST-THERAPEUTIC CT SCANS.; 5/12 (1 WITH SUBARACHNOID HEMORRHAGE (SAH) AND 4 WITHOUT SAH) HAD UNDERLYING INTRACRANIAL ATHEROSCLEROTIC STENOSIS; 1 PATIENT HAD SYMPTOMATIC HEMORRHAGE. PATIENTS WITH SAH EXHIBITED NO POSTPROCEDURAL NEUROLOGICAL DETERIORATION OR ASSOCIATED SYMPTOMATIC PARENCHYMAL HEMORRHAGE; 9 /12 PATIENTS WITH SAH SHOWED ALERT OR DROWSY MENTAL STATUS AFTER ENDOVASCULAR THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360159 SOLITAIRE REVASCULARIZATION DEVICE CATHETER, THROMBUS RETRIEVER NRY COVIDIEN (IRVINE) SFR-4-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Other