BEUDAMED
    FDA Adverse Event Death Summary report: N

    V 2.0 FIRM EXT PEBAX

    MDR report key: 3181577 · Received June 21, 2013

    Report

    Report Number
    0002954917-2013-00096
    Event Type
    Death
    Date Received
    June 21, 2013
    Date of Event
    July 7, 2011
    Report Date
    June 6, 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 DEATH 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN SUCCESSFULLY PERFORMED ONE PASS WITH THE RETRIEVAL DEVICE TO TREAT A LEFT M1 MIDDLE CEREBRAL ARTERY OCCLUSION. THE PATIENT HAD A THROMBOLYSIS IN CEREBRAL ISCHEMIA SCORE OF 2B AFTER TREATMENT. ANGIOPLASTY AND INTRA- ARTERIAL INFUSION OF 240,000 UNITS OF UROKINASE WERE USED DURING THE PROCEDURE. A SUBARACHNOID HEMORRHAGE (SAH) WAS CONFIRMED DURING THE PROCEDURE. THE NEXT DAY THE PATIENT'S CONDITION WORSENED DUE TO THE SAH RAPIDLY EXPANDED AND TWO DAYS POST PROCEDURE, THE PATIENT DIED. THE PHYSICIAN STATED THAT THE SAH WAS RELATED TO THE PROCEDURE; HOWEVER, THE CAUSAL RELATIONSHIP BETWEEN THE RETRIEVER DEVICE AND THE SAH IS UNKNOWN SINCE MULTIPLE DEVICES WERE USED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281989 V 2.0 FIRM EXT PEBAX CATHETER, THROMBUS RETRIEVER NRY CONCENTRIC MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death