BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TREVO PROVUE

    MDR report key: 5427449 · Received February 10, 2016

    Report

    Report Number
    0002954917-2016-00017
    Event Type
    Injury
    Date Received
    February 10, 2016
    Date of Event
    September 2, 2015
    Report Date
    January 14, 2016
    Manufacturer
    CONCENTRIC MEDICAL
    Product Code
    NRY
    PMA / PMN Number
    K122478
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS DISPOSED.

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD (DHR) REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE SUBJECT DEVICE IS NOT AVAILABLE; THEREFORE, FUNCTIONAL TESTING AS WELL AS PHYSICAL ANALYSIS CANNOT BE PERFORMED. HOWEVER, HEMORRHAGE IS A KNOWN RISK ASSOCIATED WITH ENDOVASCULAR PROCEDURES AND IS LISTED AS SUCH IN THE DEVICE DIRECTIONS FOR USE (DFU). THEREFORE, AN ASSIGNABLE CAUSE OF ANTICIPATED PROCEDURAL COMPLICATIONS WAS ASSIGNED TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT THROMBECTOMY WITH A RETRIEVER (THE SUBJECT DEVICE) AND A COMPETITORS DEVICE. AFTER USING THE RETRIEVER, SUBARACHNOID HEMORRHAGE (SAH) WAS NOTICED IN THE TREATED AREA. NO MEDICAL OR ENDOVASCULAR TREATMENT WAS TAKEN FOR THE SAH. THE PATIENT RECOVERED WITHOUT ANY RESIDUAL EFFECTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT THROMBECTOMY WITH A RETRIEVER (THE SUBJECT DEVICE) AND A COMPETITORS DEVICE. AFTER USING THE RETRIEVER, SUBARACHNOID HEMORRHAGE (SAH) WAS NOTICED IN THE TREATED AREA. NO MEDICAL OR ENDOVASCULAR TREATMENT WAS TAKEN FOR THE SAH. THE PATIENT RECOVERED WITHOUT ANY RESIDUAL EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86397 TREVO PROVUE CATHETER, THROMBUS RETRIEVER NRY CONCENTRIC MEDICAL 37639

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other