BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V 2.5 FIRM EXT

    MDR report key: 3173331 · Received June 17, 2013

    Report

    Report Number
    0002954917-2013-00092
    Event Type
    Injury
    Date Received
    June 17, 2013
    Date of Event
    December 15, 2011
    Report Date
    June 6, 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 VASOSPASM ARE KNOWN RISKS ASSOCIATED WITH SUCH PROCEDURES AND NOTED AS SUCH IN THE DIRECTIONS FOR USE (DFU). THEREFORE, A ROOT CAUSE OF ANTICIPATED PROCEDURAL COMPLICATION HAS BEEN ASSIGNED TO THE EVENT.

    Description of Event or Problem · 1

    DURING THE THROMBECTOMY, FOUR PASSES WERE MADE WITH RETRIEVERS IN THE OCCLUDED M1 SEGMENT OF THE LEFT MIDDLE CEREBRAL ARTERY (LMCA). VASOSPASM OCCURRED AFTER PARTIAL REVASCULARIZATION AND HEMORRHAGIC INFARCTION AT THE M1 SEGMENT OF THE LMCA WAS CONFIRMED. 11.2 MG OF T-PA WAS INTRAVENOUSLY ADMINISTERED. THE PHYSICIAN STATED THAT THE HEMORRHAGIC INFARCTION CAUSED THE VASOSPASM. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273050 V 2.5 FIRM EXT CATHETER, THROMBUS RETRIEVER NRY CONCENTRIC MEDICAL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Other V 3.0 FIRM (CONCENTRIC MEDICAL)