BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TREVO XP PROVUE RETRIEVER 4X20

    MDR report key: 3934042 · Received July 15, 2014

    Report

    Report Number
    0002954917-2014-00011
    Event Type
    Injury
    Date Received
    July 15, 2014
    Date of Event
    May 20, 2014
    Report Date
    June 25, 2014
    Manufacturer
    CONCENTRIC MEDICAL
    Product Code
    NRY
    PMA / PMN Number
    K132641
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS 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. HEMORRHAGE 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 RIGHT M1 MIDDLE CEREBRAL ARTERY OCCLUSION (MCA) WITH THE SUBJECT RETRIEVAL DEVICE. THE PATIENT HAD A THROMBOLYSIS IN CEREBRAL ISCHEMIA SCORE OF 3 AFTER TREATMENT. HOWEVER, AFTER THE INDEX PROCEDURE WITHIN THE FIRST 48 HOURS (THE EXACT TIME IS UNKNOWN), THE PATIENT SUFFERED A SYMPTOMATIC INTRACRANIAL HEMORRHAGE. THE REPORTED EVENT REQUIRED PROLONGATION OF EXISTING HOSPITALIZATION AND MEDICAL MANAGEMENT (NOT SPECIFIED). THE PHYSICIAN RELATED THE ADVERSE EVENT POSSIBLE TO THE PROCEDURE; HOWEVER, HE STATED THAT IT WAS UNRELATED TO THE SUBJECT DEVICE. NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT SUCCESSFUL MECHANICAL THROMBECTOMY OF THE RIGHT M1 MIDDLE CEREBRAL ARTERY OCCLUSION (MCA) WITH THE SUBJECT RETRIEVAL DEVICE. THE PATIENT HAD A THROMBOLYSIS IN CEREBRAL ISCHEMIA SCORE OF 3 AFTER TREATMENT. HOWEVER, AFTER THE INDEX PROCEDURE WITHIN THE FIRST 48 HOURS (THE EXACT TIME IS UNKNOWN), THE PATIENT SUFFERED A SYMPTOMATIC INTRACRANIAL HEMORRHAGE. THE REPORTED EVENT REQUIRED PROLONGATION OF EXISTING HOSPITALIZATION AND MEDICAL MANAGEMENT (NOT SPECIFIED). THE PHYSICIAN RELATED THE ADVERSE EVENT POSSIBLE TO THE PROCEDURE; HOWEVER, HE STATED THAT IT WAS UNRELATED TO THE SUBJECT DEVICE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413472 TREVO XP PROVUE RETRIEVER 4X20 CATHETER, THROMBUS RETRIEVER NRY CONCENTRIC MEDICAL 36933

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention TREVO PRO 18 MICROCATHETER (CONCENTRIC)| MERCI BALLOON GUIDE CATHETER(CONCENTRIC)