BEUDAMED
    FDA Adverse Event Death Summary report: N

    SOLITAIRE REVASCULARIZATION DEVICE

    MDR report key: 4726556 · Received April 24, 2015

    Report

    Report Number
    2029214-2015-00416
    Event Type
    Death
    Date Received
    April 24, 2015
    Date of Event
    August 13, 2013
    Report Date
    March 25, 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

    KANG DH. SWITCHING STRATEGY FOR MECHANICAL THROMBECTOMY OF ACUTE LARGE VESSEL OCCLUSION IN THE ANTERIOR CIRCULATION. 2013 DEC;44(12):3577-9. DOI: 10.1161/STROKEAHA.113.002673. WWW.NCBI.NLM.NIH.GOV/PUBMED/24021683. THE DEVICES WERE NOT RETURNED FOR ANALYSIS. THE LOT HISTORY RECORD REVIEW WAS NOT POSSIBLE SINCE THE LOT NUMBERS WERE NOT REPORTED. THIS REPORT WAS CREATED TO CAPTURE THE EVENTS THAT WERE RELATED TO THE TO THE SOLITAIRE PROCEDURES. (B)(4). MDR # 2029214-2015-00415 WAS GENERATED TO CAPTURE THE DEATHS.

    Description of Event or Problem · 1

    MEDTRONIC (COVIDIEN) RECEIVED THE FOLLOW INFORMATION THROUGH REVIEW OF ARTICLE ";SWITCHING STRATEGY FOR MECHANICAL THROMBECTOMY OF ACUTE LARGE VESSEL OCCLUSION IN THE ANTERIOR CIRCULATION". SEVENTY-FOUR PATIENTS THAT WERE TREATED WITH A SOLITAIRE FR DEVICE, 5/74 REPORTS CONSISTED OF SUBARACHNOID HEMORRHAGE (SAH) ASSOCIATED WITH DISSECTION OF THE OCCLUDED VESSEL. 4/5 PATIENTS DIED AS A RESULT OF THIS EVENT, 1/4 HAD MIGRATION OF THE CLOT INTO THE CONTRALATERAL ANTERIOR CEREBRAL ARTERY. 21 /74 PATIENTS SUFFERED INTRACRANIAL HEMORRHAGE. 4 PATIENTS HAD SYMPTOMATIC HEMORRHAGES. 7 CASE WERE REPORTED TO HAVE HEMORRHAGE AT {24HRS AND 24-48HRS. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272694 SOLITAIRE REVASCULARIZATION DEVICE CATHETER, THROMBUS RETRIEVER NRY COVIDIEN (IRVINE) SOLITAIRE FR

    Patients

    Seq Age Sex Outcome Treatment
    1 Death