BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TREVO XP PROVUE RETRIEVER 3X20

    MDR report key: 6768700 · Received August 4, 2017

    Report

    Report Number
    0002954917-2017-00074
    Event Type
    Injury
    Date Received
    August 4, 2017
    Date of Event
    December 20, 2016
    Report Date
    October 25, 2017
    Manufacturer
    CONCENTRIC MEDICAL
    Product Code
    NRY
    PMA / PMN Number
    K133464
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 SUBJECT DEVICE IS NOT AVAILABLE; THEREFORE, FUNCTIONAL TESTING AS WELL AS PHYSICAL ANALYSIS CANNOT BE PERFORMED. HOWEVER, ADVERSE EVENTS ASSOCIATED WITH THE USE OF RETRIEVERS OR WITH THE ENDOVASCULAR PROCEDURES INCLUDE, BUT ARE NOT LIMITED TO: HEMATOMA AND HEMORRHAGE AND NOTED AS SUCH IN THE DEVICE DIRECTIONS FOR USE (DFU). THEREFORE, AN ASSIGNABLE CAUSE OF ANTICIPATED PROCEDURAL COMPLICATIONS HAS BEEN ASSIGNED TO THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE IS NOT AVAIALBLE.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT MECHANICAL THROMBECTOMY PROCEDURE TO TREAT LEFT MIDDLE CEREBRAL ARTERY (MCA) M1 OCCLUSION USING THE SUBJECT RETRIEVER AND A NON-STRYKER RETRIEVER. PRE-PROCEDURE THE PATIENT WAS ASSESSED HAVING THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) OF 0 AND POST PROCEDURE TICI OF 2B, CONFIRMING SUCCESSFUL RECANALIZATION OF VESSEL. HOWEVER, POST PROCEDURE THE PATIENT DEVELOPED THE SYMPTOMATIC CRANIAL HEMORRHAGE, (TYPE 2 PARENCHYMAL HEMATOMA (PH2) AND SUBARACHNOID HEMORRHAGE (SAH)) IN THE TREATMENT AREA. NO ADDITIONAL TREATMENT WAS PERFORMED FOR THE SYMPTOMATIC CRANIAL HEMORRHAGE AND THE OPERATION WAS FINISHED. THE PATIENT HAD IMPAIRED CONSCIOUSNESS CAUSED BY THE SYMPTOMATIC CRANIAL HEMORRHAGE. IN PHYSICIAN'S OPINION, THE CAUSE OF THE SYMPTOMATIC CRANIAL HEMORRHAGE PH2 AND SAH WAS NOT CLEAR. THE PHYSICIAN DID NOT ALLEGE ANY MALFUNCTION OF ANY DEVICE FOR THIS PROCEDURE.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT MECHANICAL THROMBECTOMY PROCEDURE TO TREAT LEFT MIDDLE CEREBRAL ARTERY (MCA) M1 OCCLUSION USING THE SUBJECT RETRIEVER AND A NON-STRYKER RETRIEVER. PRE-PROCEDURE THE PATIENT WAS ASSESSED HAVING THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) OF 0 AND POST PROCEDURE TICI OF 2B, CONFIRMING SUCCESSFUL RECANALIZATION OF VESSEL. HOWEVER, POST PROCEDURE THE PATIENT DEVELOPED THE SYMPTOMATIC CRANIAL HEMORRHAGE, (TYPE 2 PARENCHYMAL HEMATOMA (PH2) AND SUBARACHNOID HEMORRHAGE (SAH)) IN THE TREATMENT AREA. NO ADDITIONAL TREATMENT WAS PERFORMED FOR THE SYMPTOMATIC CRANIAL HEMORRHAGE AND THE OPERATION WAS FINISHED. THE PATIENT HAD IMPAIRED CONSCIOUSNESS CAUSED BY THE SYMPTOMATIC CRANIAL HEMORRHAGE. IN PHYSICIAN'S OPINION, THE CAUSE OF THE SYMPTOMATIC CRANIAL HEMORRHAGE PH2 AND SAH WAS NOT CLEAR. THE PHYSICIAN DID NOT ALLEGE ANY MALFUNCTION OF ANY DEVICE FOR THIS PROCEDURE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547362 TREVO XP PROVUE RETRIEVER 3X20 CATHETER, THROMBUS RETRIEVER NRY CONCENTRIC MEDICAL 60405

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Other