BEUDAMED
    FDA Adverse Event Death Summary report: N

    TREVO PROVUE

    MDR report key: 2933872 · Received January 29, 2013

    Report

    Report Number
    0002954917-2013-00008
    Event Type
    Death
    Date Received
    January 29, 2013
    Date of Event
    January 7, 2013
    Report Date
    January 15, 2013
    Manufacturer
    CONCENTRIC MEDICAL
    Product Code
    NRY
    PMA / PMN Number
    K122478
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS DISPOSED.

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE SUBJECT DEVICE IS NOT AVAILABLE FOR ANALYSIS. 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, VESSEL DISSECTION AND PATIENT OUTCOME OF DEATH ARE KNOWN AND ANTICIPATED RISK ASSOCIATED WITH THESE TYPES OF PROCEDURES AND NOTED AS SUCH IN THE DIRECTIONS FOR USE (DFU). THEREFORE, A ROOT CAUSE OF ANTICIPATED PROCEDURAL COMPLICATION HAS BEEN ASSIGNED TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN OPENED WITH MULTIPLE PASSES THE OCCLUDED RIGHT M1, M2 SEGMENTS, AND NOTICE WHAT APPEARED TO BE AN OCCLUSION IN THE ANTERIOR COMMUNICATING ARTERY A2 SEGMENT. AFTER CROSSING THE LESION WITH THE MICROCATHETER, ANGIOGRAPHY RUN REVEALED THAT THE "CLOT" WAS FROM AN INTRACRANIAL BLEED SUSTAINED DURING THE TRAFFIC ACCIDENT THE PATIENT WAS INVOLVED IN PRIOR TO ADMISSION. THE PHYSICIAN TERMINATED THE PROCEDURE AND TRANSFERRED THE PATIENT FOR FOLLOW UP TREATMENT. IT WAS REPORTED THAT APPROXIMATELY 30 MINUTES POST PROCEDURE, THE PATIENT DIED. THE PHYSICIAN FEELS THAT THE PATIENT'S OUTCOME OF DEATH WAS DUE TO A VESSEL DISSECTION WHICH IS UNKNOWN WHETHER IT WAS PRESENT PRIOR TO THE THROMBECTOMY PROCEDURE. THE PRIMARY CAUSE OF DEATH WAS DUE TO AN INTRAPARENCHYMAL BLEED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN OPENED WITH MULTIPLE PASSES THE OCCLUDED RIGHT M1, M2 SEGMENTS, AND NOTICE WHAT APPEARED TO BE AN OCCLUSION IN THE ANTERIOR COMMUNICATING ARTERY A2 SEGMENT. AFTER CROSSING THE LESION WITH THE MICROCATHETER, ANGIOGRAPHY RUN REVEALED THAT THE "CLOT" WAS FROM AN INTRACRANIAL BLEED SUSTAINED DURING THE TRAFFIC ACCIDENT THE PATIENT WAS INVOLVED IN PRIOR TO ADMISSION. THE PHYSICIAN TERMINATED THE PROCEDURE AND TRANSFERRED THE PATIENT FOR FOLLOW UP TREATMENT. IT WAS REPORTED THAT APPROXIMATELY 30 MINUTES POST PROCEDURE, THE PATIENT DIED. THE PHYSICIAN FEELS THAT THE PATIENT'S OUTCOME OF DEATH WAS DUE TO A VESSEL DISSECTION WHICH IS UNKNOWN WHETHER IT WAS PRESENT PRIOR TO THE THROMBECTOMY PROCEDURE. THE PRIMARY CAUSE OF DEATH WAS DUE TO AN INTRAPARENCHYMAL BLEED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38716 TREVO PROVUE CATHETER, THROMBUS RETRIEVER NRY CONCENTRIC MEDICAL 36238

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death| O TREVO PRO 18 MICROCATHETER (CONCENTRIC)