BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLITAIRE FR REVASCULARIZATION DEVICE

    MDR report key: 5029995 · Received August 25, 2015

    Report

    Report Number
    2029214-2015-00938
    Event Type
    Injury
    Date Received
    August 25, 2015
    Date of Event
    November 18, 2014
    Report Date
    July 30, 2015
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    NRY
    PMA / PMN Number
    K113455
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT WAS CREATED TO CAPTURE THE POST PROCEDURE COMPLICATIONS THAT WERE RECEIVED FROM THE ARTICLE MITCHELL B, CHINNADURAI P, CHINTALAPANI G. ENDOVASCULAR RECANALIZATION IN ACUTE ISCHEMIC STROKE USING THE SOLITAIRE FR REVASCULARIZATION DEVICE WITH ADJUNCTIVE C-ARM CT IMAGING. AJNR. 18-NOV-2014; 36:1317¿20. THE DEVICES INVOLVED IN THE EVENT WERE NOT RETURNED FOR EVALUATION AND NO CORRESPONDENCE HAS BEEN RECEIVED REGARDING RETURN OF THE DEVICES. THE LOT HISTORY RECORD REVIEWS WERE NOT POSSIBLE SINCE THE LOT NUMBERS WERE NOT REPORTED. (B)(4).

    Description of Event or Problem · 1

    CITATION: MEDTRONIC RECEIVED INFORMATION THROUGH LITERATURE REVIEW OF THE ARTICLE MITCHELL B, CHINNADURAI P, CHINTALAPANI G. ENDOVASCULAR RECANALIZATION IN ACUTE ISCHEMIC STROKE USING THE SOLITAIRE FR REVASCULARIZATION DEVICE WITH ADJUNCTIVE C-ARM CT IMAGING. AJNR. 18-NOV-2014; 36:1317-20. EIGHTEEN CASES OF MECHANICAL THROMBECTOMY FOR TREATMENT OF ACUTE ISCHEMIC STROKES WHERE A C-ARM WAS USED TO AID POOR VISUALIZATION WERE REVIEWED AND FIVE PATIENTS WERE REPORTED TO HAVE SUFFERED PETECHIAL OR SMALL BASAL GANGLIA HEMORRHAGE POST PROCEDURE. DESPITE THE LIMITED EXTENT OF HEMORRHAGE, 4 OF THOSE 5 PATIENTS ACTUALLY ACHIEVED RECANALIZATION DURING TREATMENT AND 2 OF THESE 5 ULTIMATELY DIED. THE RELATIONSHIP OF THE DEATH TO THE DEVICE WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562475 SOLITAIRE FR REVASCULARIZATION DEVICE CATHETER, THROMBUS RETRIEVER NRY COVIDIEN (IRVINE) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other