BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TREVO XP PROVUE RETRIEVER 3X20

    MDR report key: 4223079 · Received November 4, 2014

    Report

    Report Number
    0002954917-2014-00036
    Event Type
    Injury
    Date Received
    November 4, 2014
    Date of Event
    August 24, 2014
    Report Date
    October 15, 2014
    Manufacturer
    CONCENTRIC MEDICAL
    Product Code
    NRY
    PMA / PMN Number
    K133464
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. THROMBOSIS AND HEMORRHAGE 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. THE DEVICE IS NOT AVAILABLE TO THE MANUFACTURER.

    Description of Event or Problem · 1

    THE INITIAL CLOT LOCATED IN THE LEFT M3 MIDDLE CEREBRAL ARTERY (MCA) WAS NOT REMOVED WITH THE SUBJECT RETRIEVAL DEVICE AND A THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) SCORE REMAINED ¿0¿. AFTER THE SUBJECT RETRIEVER WAS REMOVED, EMBOLIZATION TO NEW LEFT MCA-M1 TERRITORY WAS NOTED. A DIFFERENT RETRIEVER DEVICE WAS USED AND THE THROMBUS WAS REMOVED. THE NEXT DAY IMAGING DEMONSTRATED A MINIMAL PETECHIAL HEMORRHAGE. THE FOLLOWING DAY IMAGING SHOWED ¿ESSENTIALLY STABLE HEMORRHAGE¿. THERE WAS NO FURTHER TREATMENT ADMINISTERED TO THE PATIENT AND TWO DAYS POST PROCEDURE, THE PATIENT WAS DISCHARGED HOME DOING ¿VERY WELL¿.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705563 TREVO XP PROVUE RETRIEVER 3X20 CATHETER, THROMBUS RETRIEVER NRY CONCENTRIC MEDICAL 37047

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention