BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN_NEUROVASCULAR_PRODUCT

    MDR report key: 4910779 · Received July 13, 2015

    Report

    Report Number
    0002954917-2015-00059
    Event Type
    Death
    Date Received
    July 13, 2015
    Date of Event
    March 6, 2015
    Report Date
    June 26, 2015
    Manufacturer
    CONCENTRIC MEDICAL
    Product Code
    NRY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE TO THE MANUFACTURER.

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE DEVICE WAS NOT AVAILABLE FOR ANALYSIS. FROM THE INFORMATION PROVIDED THERE WAS NO INDICATION THAT THE DEVICE WAS NOT USED AS IN ACCORDANCE WITH THE LABELING OR THAT THIS CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. HEMORRHAGE AND DEATH ARE KNOWN AND ANTICIPATED COMPLICATIONS TO THESE TYPES OF PROCEDURES AND ARE NOTED IN THE LABELING. THEREFORE, IT WAS DETERMINED THAT THE REPORTED EVENT WAS AN ANTICIPATED PROCEDURAL COMPLICATION.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT SUCCESSFUL MECHANICAL THROMBECTOMY OF THE LEFT M1 MIDDLE CEREBRAL ARTERY (MCA) OCCLUSION WITH THE SUBJECT RETRIEVAL DEVICE. COMPLETE REVASCULARIZATION OF THE LEFT MCA WAS ACHIEVED WITH A THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) SCORE OF 2B. THE NEXT DAY POST PROCEDURE, A SYMPTOMATIC INTRACRANIAL HEMORRHAGE (ICH) OCCURRED, WHICH LED TO THE PATIENT DEATH 11 DAYS POST PROCEDURE. THERE WAS NO TREATMENT PROVIDED. THE EVENT WAS REPORTED AS NOT RELATED TO THE DEVICE BUT RELATED TO THE PROCEDURE.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT SUCCESSFUL MECHANICAL THROMBECTOMY OF THE LEFT M1 MIDDLE CEREBRAL ARTERY (MCA) OCCLUSION WITH THE SUBJECT RETRIEVAL DEVICE. COMPLETE REVASCULARIZATION OF THE LEFT MCA WAS ACHIEVED WITH A THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) SCORE OF 2B. THE NEXT DAY POST PROCEDURE, A SYMPTOMATIC INTRACRANIAL HEMORRHAGE (ICH) OCCURRED, WHICH LED TO THE PATIENT DEATH 11 DAYS POST PROCEDURE. THERE WAS NO TREATMENT PROVIDED. THE EVENT WAS REPORTED AS NOT RELATED TO THE DEVICE BUT RELATED TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452597 UNKNOWN_NEUROVASCULAR_PRODUCT CATHETER, THROMBUS RETRIEVER NRY CONCENTRIC MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death SELECT PLUS MICROCATHETER (CODMAN)