BEUDAMED
    FDA Adverse Event Death Summary report: N

    V 2.5 FIRM EXT

    MDR report key: 3094065 · Received May 6, 2013

    Report

    Report Number
    0002954917-2013-00062
    Event Type
    Death
    Date Received
    May 6, 2013
    Date of Event
    June 10, 2012
    Report Date
    April 24, 2013
    Manufacturer
    CONCENTRIC MEDICAL
    Product Code
    NRY
    PMA / PMN Number
    K090085
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE IS NOT AVAILABLE; THEREFORE, ANALYSIS CANNOT BE PERFORMED. FROM THE INFORMATION AVAILABLE, THERE IS NO INDICATION THAT THE REPORTED EVENT IS RELATED TO PRODUCT SPECIFICATIONS NONCONFORMANCE OR MISUSE. THERE IS ALSO NO INDICATION THAT THE SUBJECT DEVICE MALFUNCTIONED. HOWEVER, HEMORRHAGE AND PATIENT OUTCOME OF DEATH ARE KNOWN RISKS ASSOCIATED WITH ENDOVASCULAR PROCEDURES AND NOTED AS SUCH IN THE DIRECTIONS FOR USE (DFU). THEREFORE, A ROOT CAUSE OF ANTICIPATED PROCEDURAL COMPLICATION HAS BEEN ASSIGNED TO THIS EVENT. SUBJECT DEVICE IS NOT AVAILABLE.

    Description of Event or Problem · 1

    DURING A THROMBECTOMY PROCEDURE, TWO RETRIEVERS WERE USED IN THE OCCLUDED BASILAR ARTERY. IT WAS REPORTED THAT DURING PROCEDURE, EXTRAVASATION OF MEDIA DEVELOPED INTO A SUBARACHNOID HEMORRHAGE (SAH). APPROXIMATELY, TWO HOURS POST PROCEDURE, THE PATIENT'S SAH DID NOT IMPROVE AND THE PATIENT DIED. THE PHYSICIAN INDICATED THAT THE CAUSE OF THE SAH WAS DUE TO THE VESSEL BEING PULLED TOGETHER UPON WITHDRAWAL OF THE RETRIEVERS AND THAT THE PATIENT DEATH IS RELATED TO THE SAH. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197195 V 2.5 FIRM EXT CATHETER, THROMBUS RETRIEVER NRY CONCENTRIC MEDICAL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death| O 40.0MG TPA (UNKNOWN PHARMACEUTICAL)| V 2.5 SOFT EXT (CONCENTRIC)