BEUDAMED
    FDA Adverse Event Death Summary report: N

    SOLITAIRE FR REVASCULARIZATION DEVICE

    MDR report key: 4760219 · Received May 8, 2015

    Report

    Report Number
    2029214-2015-00524
    Event Type
    Death
    Date Received
    May 8, 2015
    Date of Event
    August 13, 2014
    Report Date
    April 14, 2015
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    NRY
    PMA / PMN Number
    K113455
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT WAS CREATED TO CAPTURE THE DEATHS REPORTED IN THE ARTICLE THAT CAN BE FOUND ONLINE AT: HTTP://DX.DOI.ORG/10.3174/AJNR.A4133. THE DEVICES INVOLVED IN THE EVENT WERE NOT RETURNED FOR EVALUATION. NO FURTHER INFORMATION WERE PROVIDED REGARDING THE DEVICES. THE LOT HISTORY RECORD REVIEWS WERE NOT POSSIBLE AS THE LOT NUMBERS WERE NOT PROVIDED. (B)(4).

    Description of Event or Problem · 1

    MEDTRONIC / COVIDIEN RECEIVED INFORMATION THROUGH LITERATURE REVIEW OF "DOUBLE SOLITAIRE MECHANICAL THROMBECTOMY IN ACUTE STROKE: EFFECTIVE RESCUE STRATEGY FOR REFRACTORY ARTERY OCCLUSIONS?" BY AUTHOR J. KLISCH. OUT OF 10 PATIENTS, IT WAS REPORTED THAT 9 PATIENTS HAD THE SINGLE SOLITAIRE TECHNIQUE APPLIED FIRST WITH AN AVERAGE OF 3 PASSES (1 ¿ 4 PASSES). ONE PATIENT HAD THE PROCEDURE STARTED WITH THE DOUBLE SOLITAIRE TECHNIQUE TO AVOID FRAGMENTING THE THROMBUS DUE TO THE LENGTH OF THE THROMBUS. FIVE PATIENTS WERE REPORTED TO HAVE MRS 2. THREE PATIENTS WERE REPORTED TO HAVE MRS 4 AND TWO PATIENTS WERE REPORTED TO HAVE EXPIRED. COMPLETE RECANALIZATION (TICI 2B/3) WAS ACHIEVED IN EIGHT PATIENTS. TWO DEATHS WERE REPORTED. ONE PATIENT (PATIENT 8) WAS REPORTED TO HAVE EXPIRED DUE TO A MALIGNANT INFARCT FOLLOWING FAILED RECANALIZATION OF AN ICAT (INTERNAL CAROTID ARTERY) TERMINUS OCCLUSION. THE RECANALIZATION FAILED DUE TO A REFRACTORY ICAT STENOSIS WHICH MADE VASCULAR ACCESS DIFFICULT. THE OTHER PATIENT (PATIENT 6) HAD SUCCESSFUL RECANALIZATION OF AN ICAT OCCLUSION WITH INITIAL NEUROLOGIC IMPROVEMENT AND THEN SECONDARY DETERIORATION 3 WEEKS LATER, WITH APHASIA AND HEMIPARESIS DUE TO PRESUMED RE-INFARCTION. SUBSEQUENTLY, THE PATIENT EXPIRED. THE INFORMATION WAS RECEIVED FROM THE SAME ARTICLE AS MDR# 2029214-2015-00525.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304508 SOLITAIRE FR REVASCULARIZATION DEVICE CATHETER, THROMBUS RETRIEVER NRY COVIDIEN (IRVINE) SOLITAIRE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death