BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TREVO XP PROVUE RETRIEVER 4X20

    MDR report key: 3903433 · Received June 30, 2014

    Report

    Report Number
    0002954917-2014-00009
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 13, 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 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. THROMBOEMBOLISM 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.

    Description of Event or Problem · 1

    FOLLOWING INFUSION OF 4 MG OF TISSUE PLASMINOGEN ACTIVATOR (TPA), A MECHANICAL THROMBECTOMY USING THE SUBJECT DEVICE WAS SUCCESSFULLY PERFORMED TO TREAT A LEFT M1 MIDDLE CEREBRAL ARTERY OCCLUSION. THE PATIENT HAD A THROMBOLYSIS IN CEREBRAL ISCHEMIA SCORE OF 2B AFTER TREATMENT. EMBOLI WERE OBSERVED AT THE LEFT ANTERIOR CEREBRAL ARTERY (ACA) AT THE END OF THE PROCEDURE AND IMAGING SHOWED SOME HEMORRHAGIC CONVERSION; HOWEVER, CLINICALLY THE PATIENT¿S CONDITION WAS ¿REMARKABLY WELL¿. THERE WAS NO TREATMENT GIVEN TO THE PATIENT DUE TO THE EVENT. REPEAT IMAGING CONFIRMED THAT THERE WAS NO EVIDENCE OF HEMORRHAGE ANY MORE. FIVE DAYS POST PROCEDURE, THE PATIENT WAS DISCHARGED HOME IN GOOD CONDITION WITHOUT ANY NEUROLOGICAL DEFICIT.

    Description of Event or Problem · 1

    FOLLOWING INFUSION OF 4 MG OF TISSUE PLASMINOGEN ACTIVATOR (TPA), A MECHANICAL THROMBECTOMY USING THE SUBJECT DEVICE WAS SUCCESSFULLY PERFORMED TO TREAT A LEFT M1 MIDDLE CEREBRAL ARTERY OCCLUSION. THE PATIENT HAD A THROMBOLYSIS IN CEREBRAL ISCHEMIA SCORE OF 2B AFTER TREATMENT. EMBOLI WERE OBSERVED AT THE LEFT ANTERIOR CEREBRAL ARTERY (ACA) AT THE END OF THE PROCEDURE AND IMAGING SHOWED SOME HEMORRHAGIC CONVERSION; HOWEVER, CLINICALLY THE PATIENT'S CONDITION WAS "REMARKABLY WELL". THERE WAS NO TREATMENT GIVEN TO THE PATIENT DUE TO THE EVENT. REPEAT IMAGING CONFIRMED THAT THERE WAS NO EVIDENCE OF HEMORRHAGE ANY MORE. FIVE DAYS POST PROCEDURE, THE PATIENT WAS DISCHARGED HOME IN GOOD CONDITION WITHOUT ANY NEUROLOGICAL DEFICIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379899 TREVO XP PROVUE RETRIEVER 4X20 CATHETER, THROMBUS RETRIEVER NRY CONCENTRIC MEDICAL 36962

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other