BEUDAMED
    FDA Adverse Event Death Summary report: N

    MERCI RETRIEVER V 2.0 FIRM

    MDR report key: 2581309 · Received May 16, 2012

    Report

    Report Number
    2954917-2012-00042
    Event Type
    Death
    Date Received
    May 16, 2012
    Date of Event
    April 18, 2012
    Report Date
    May 16, 2012
    Manufacturer
    CONCENTRIC MEDICAL, INC.
    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

    THERE WAS NO EVIDENCE OF CONCENTRIC MEDICAL DEVICE MALFUNCTION AND THE DEVICE INSTRUCTIONS FOR USE LISTS RELATED POSSIBLE COMPLICATIONS. ALSO, WHILE THE CONCENTRIC MEDICAL DEVICE USE MAY HAVE CAUSED OR CONTRIBUTED TO THE PT OUTCOME, THERE ARE OTHER FACTORS INDEPENDENT OF THE SUBJECT DEVICE (E.G., PATIENT FACTORS, DEVICE USE FACTORS, OTHER DEVICES EMPLOYED, DRUGS ADMINISTERED, ETC.) THAT ALSO MAY HAVE CAUSED OR CONTRIBUTED TO THE OUTCOME. BECAUSE THE DEVICE WAS NOT RETURNED TO CONCENTRIC MEDICAL, A COMPLETE INVESTIGATION COULD NOT BE PERFORMED. ALSO, BECAUSE THE LOT NUMBER FOR THE DEVICE WAS NOT REPORTED TO CONCENTRIC MEDICAL, THE MFG RECORDS FOR THE MERCI RETRIEVER V 2.0 FIRM DEVICE COULD NOT BE REVIEWED.

    Description of Event or Problem · 1

    PT WAS A (B)(6) MALE WITH A RIGHT INTERNAL CAROTID ARTERY (ICA) OCCLUSION. PHYSICIAN MADE ONE PASS WITH A MERCI RETRIEVER V 2.0 FIRM. PT HAD A THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) SCORE OF 3 AFTER TREATMENT. POST-OPERATIVELY, A SUBARACHNOID HEMORRHAGE (SAH) WAS CONFIRMED AT M1-M2 JUNCTION OF RIGHT MIDDLE CEREBRAL ARTERY. COIL EMBOLIZATION WAS PERFORMED FOR THE SAH AS A MEDICAL INTERVENTION. PT EXPIRED 10 HOURS POST PROCEDURE DUE TO INTRACRANIAL HYPERTENSION TISSUE PLASMINOGEN ACTIVATOR (T-PA) WAS NOT USED DURING PROCEDURE. PHYSICIAN BELIEVES THAT THE MERCI RETRIEVER MAY HAVE CAUSED THE SAH SINCE THE SAH WAS CONFIRMED TO BE AROUND WHERE THE MERCI RETRIEVER HAD BEEN DEPLOYED. PHYSICIAN ALSO BELIEVES THAT THE PT'S OUTCOME WAS DUE TO INTRACRANIAL HYPERTENSION ATTRIBUTED TO THE SAH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MERCI RETRIEVER V 2.0 FIRM CATHETER, PERCUTANEOUS NRY CONCENTRIC MEDICAL, INC. 90110 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death| O| R