BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V 2.0 FIRM EXT PEBAX

    MDR report key: 3012767 · Received March 20, 2013

    Report

    Report Number
    0002954917-2013-00034
    Event Type
    Injury
    Date Received
    March 20, 2013
    Date of Event
    September 1, 2012
    Report Date
    March 8, 2013
    Manufacturer
    CONCENTRIC MEDICAL
    Product Code
    NRY
    PMA / PMN Number
    K090085
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE TO THE MANUFACTURE.

    Additional Manufacturer Narrative · 1

    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 PHYSICIAN SUCCESSFULLY PERFORMED THREE PASSES WITH RETRIEVAL DEVICES TO TREAT A LEFT MIDDLE CEREBRAL ARTERY (L-MCA) M2 OCCLUSION. THE PATIENT HAD A THROMBOLYSIS IN CEREBRAL ISCHEMIA (TICI) SCORE OF 2A AFTER TREATMENT. A SYLVIAN FISSURE SUBARACHNOID HEMORRHAGE (SAH) HAS BEEN CONFIRMED AFTER THE SOFT RETRIEVAL DEVICE WAS RETRIEVED. THE PHYSICIAN STATED THAT THE CAUSE OF THE SAH MAY BE RELATED TO VESSEL DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN SUCCESSFULLY PERFORMED THREE PASSES WITH RETRIEVAL DEVICES TO TREAT A LEFT MIDDLE CEREBRAL ARTERY (L-MCA) M2 OCCLUSION. THE PATIENT HAD A THROMBOLYSIS IN CEREBRAL ISCHEMIA (TICI) SCORE OF 2A AFTER TREATMENT. A SYLVIAN FISSURE SUBARACHNOID HEMORRHAGE (SAH) HAS BEEN CONFIRMED AFTER THE SOFT RETRIEVAL DEVICE WAS RETRIEVED. THE PHYSICIAN STATED THAT THE CAUSE OF THE SAH MAY BE RELATED TO VESSEL DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115895 V 2.0 FIRM EXT PEBAX CATHETER, THROMBUS RETRIEVER NRY CONCENTRIC MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other MERCI RETRIEVER (CONCENTRIC)