BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TREVO XP PROVUE RETRIEVER 4X20

    MDR report key: 3822084 · Received May 20, 2014

    Report

    Report Number
    0002954917-2014-00006
    Event Type
    Injury
    Date Received
    May 20, 2014
    Date of Event
    April 7, 2014
    Report Date
    May 8, 2014
    Manufacturer
    CONCENTRIC MEDICAL
    Product Code
    NRY
    PMA / PMN Number
    K132641
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS 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. VASOSPASM IS A KNOWN AND ANTICIPATED COMPLICATION TO THESE TYPES OF PROCEDURES AND IS NOTED IN THE LABELING. THEREFORE, IT WAS DETERMINED THAT THE REPORTED EVENT WAS AN ANTICIPATED PROCEDURAL COMPLICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT SUCCESSFUL MECHANICAL THROMBECTOMY OF THE LEFT MIDDLE CEREBRAL ARTERY OCCLUSION (L-MCA) WITH THE SUBJECT RETRIEVAL DEVICE. POST PROCEDURE FOLLOW-UP ARTERIOGRAM DEMONSTRATED COMPLETE REPERFUSION OF THE MCA. THE PATIENT HAD A THROMBOLYSIS IN CEREBRAL ISCHEMIA SCORE OF 2B AFTER TREATMENT. HOWEVER, A MILD VASOSPASM WAS NOTED IN THE LEFT M2 MCA, ¿WHICH THE RETRIEVAL DEVICE WAS PLACED WITHIN¿. THE VASOSPASM WAS RESOLVED WITH AN INTRA-ARTERIAL ADMINISTRATION OF 75 MCG NITROGLYCERIN AND 7.5 MG VERAPAMIL OVER APPROXIMATELY 10 MINUTES DURATION. AFTER THE PROCEDURE, THE PATIENT WAS EXTUBATED WITH NO IMMEDIATE NEUROLOGICAL COMPLICATION AND TRANSFERRED TO THE NEUROLOGICAL CRITICAL CARE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT SUCCESSFUL MECHANICAL THROMBECTOMY OF THE LEFT MIDDLE CEREBRAL ARTERY OCCLUSION (L-MCA) WITH THE SUBJECT RETRIEVAL DEVICE. POST PROCEDURE FOLLOW-UP ARTERIOGRAM DEMONSTRATED COMPLETE REPERFUSION OF THE MCA. THE PATIENT HAD A THROMBOLYSIS IN CEREBRAL ISCHEMIA SCORE OF 2B AFTER TREATMENT. HOWEVER, A MILD VASOSPASM WAS NOTED IN THE LEFT M2 MCA, "WHICH THE RETRIEVAL DEVICE WAS PLACED WITHIN". THE VASOSPASM WAS RESOLVED WITH AN INTRA-ARTERIAL ADMINISTRATION OF 75 MCG NITROGLYCERIN AND 7.5 MG VERAPAMIL OVER APPROXIMATELY 10 MINUTES DURATION. AFTER THE PROCEDURE, THE PATIENT WAS EXTUBATED WITH NO IMMEDIATE NEUROLOGICAL COMPLICATION AND TRANSFERRED TO THE NEUROLOGICAL CRITICAL CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299795 TREVO XP PROVUE RETRIEVER 4X20 CATHETER, THROMBUS RETRIEVER NRY CONCENTRIC MEDICAL 36913

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention PROWLER MICROCATHETER (CODMAN)