BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLITAIRE REVASCULARIZATION DEVICE

    MDR report key: 4912362 · Received July 14, 2015

    Report

    Report Number
    2029214-2015-00787
    Event Type
    Injury
    Date Received
    July 14, 2015
    Date of Event
    May 4, 2015
    Report Date
    June 17, 2015
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    NRY
    PMA / PMN Number
    K113455
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION AS IT WAS DISCARDED AT THE SITE. BASED ON THE REPORTED INFORMATION, THERE DID NOT APPEAR TO HAVE BEEN ANY DEFECT OF THE DEVICE DURING USE. THE EVENT OCCURRED IN THE PATIENT POST PROCEDURE AND ITS CAUSE WAS UNKNOWN. THE LOT HISTORY RECORD REVIEW OF THE REPORTED LOT NUMBERS SHOWED NO DISCREPANCIES THAT MIGHT HAVE CONTRIBUTED TO THE REPORTED EXPERIENCE. (B)(4).

    Description of Event or Problem · 1

    (B)(6) STUDY /MEDTRONIC (COVIDIEN) RECEIVED REPORT THAT SHORTLY AFTER THE THROMBECTOMY PROCEDURE, CRANIAL COMPUTED TOMOGRAPHY (CT) IMAGE REVEALED CEREBRAL HEMORRHAGE. HEPARIN REVERSAL AND ANTIHYPERTENSIVE TREATMENTS WERE PROVIDED TO CONTROL THE HEMORRHAGE. OCCLUDED VESSEL WAS LEFT MIDDLE CEREBRAL ARTERY, INITIAL THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) WAS 0. THE TARGET VESSEL WAS NOT RE-VASCULARIZED BY TISSUE PLASMINOGEN ACTIVATOR (TPA) TREATMENT AND SOLITAIRE FR 4-20 MECHANICAL THROMBOLYSIS WAS PERFORMED AND ACHIEVED TICI 3/ ARTERIAL OCCLUSIVE LESION (AOL) 3 WAS ACHIEVED. NINE DAYS LATER, MODIFIED RANKIN SCALE(MRS) WAS 4. ALMOST ONE MONTH LATER, THE PATIENT'S CONDITION WAS CONFIRMED AS BEING STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454923 SOLITAIRE REVASCULARIZATION DEVICE CATHETER, THROMBUS RETRIEVER NRY COVIDIEN (IRVINE) SFR-4-20 A026665

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Other| R