BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V 2.0 SOFT EXT PTFE

    MDR report key: 3222593 · Received July 12, 2013

    Report

    Report Number
    0002954917-2013-00102
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    December 15, 2012
    Report Date
    June 21, 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 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 AND HYDROCEPHALUS 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 AND PATIENT COMPLICATION RESPECTIVELY. THE DEVICE IS NOT AVAILABLE TO THE MANUFACTURE.

    Description of Event or Problem · 1

    FOLLOWING AN INTRAVENOUS INFUSION OF 25.7 MG OF TISSUE PLASMINOGEN ACTIVATOR (TPA), ONE PASS WITH RETRIEVAL DEVICE WAS SUCCESSFULLY PERFORMED TO TREAT A LEFT M2 MIDDLE CEREBRAL ARTERY OCCLUSION (L-MCA). THE PATIENT HAD A THROMBOLYSIS IN CEREBRAL ISCHEMIA SCORE OF 0 AFTER TREATMENT. A SUBARACHNOID HEMORRHAGE (SAH) AT THE M2 L-MCA WAS CONFIRMED RIGHT AFTER THE PROCEDURE. THE NEXT DAY THE PATIENT DEVELOPED A HYDROCEPHALUS. A LUMBAR SPINAL FLUID DRAINAGE WAS PLACED TO TREAT THE HYDROCEPHALUS. THE PHYSICIAN STATED THAT THE CAUSE OF THE SAH MAY BE RELATED TO VESSEL DAMAGE THAT WAS ATTRIBUTED TO THE DEVICE AND THE HYDROCEPHALUS WAS A COMPLICATION OF THE SAH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322724 V 2.0 SOFT EXT PTFE CATHETER, THROMBUS RETRIEVER NRY CONCENTRIC MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention