BEUDAMED
    FDA Adverse Event Death Summary report: N

    MERCI RETRIEVER V 3.0 FIRM

    MDR report key: 2484975 · Received March 7, 2012

    Report

    Report Number
    2954917-2012-00012
    Event Type
    Death
    Date Received
    March 7, 2012
    Date of Event
    August 24, 2011
    Report Date
    March 7, 2012
    Manufacturer
    CONCENTRIC MEDICAL, INC.
    Product Code
    NRY
    PMA / PMN Number
    K090085
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    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., PT FACTORS, DEVICE USE FACTORS, OTHER DEVICES EMPLOYED, DRUGS ADMINISTERED, ETC) THAT 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 3.0 FIRM DEVICE COULD NOT BE REVIEWED.

    Description of Event or Problem · 1

    PLEASE REFER TO MEDWATCH MFR REPORT# 2954917-2012-00009. THIS IS FOR THE FOURTH DEVICE INVOLVED IN THE CASE. PT WAS A (B)(6) FEMALE WITH A LEFT INTERNAL CAROTID ARTERY (ICA), A1 AND LEFT MIDDLE CEREBRAL ARTERY (MCA). PHYSICIAN MADE ONE PASS WITH A MERCI RETRIEVER V 2.5 SOFT, TWO PASSES WITH A MERCI RETRIEVER 2.5 FIRM AND ONE PASS WITH A MERCI RETRIEVER V 3.0 FIRM. AFTER THIS, AN OCCLUSION FROM ICA TERMINAL TO M1 REMAINED. PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WAS USED TO BREAK THE CLOT WHICH RESULTED IN REVASCULARIZATION UP TO THE ICA-TERMINAL. PT HAD A THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) SCORE OF 1 AFTER THE TREATMENT. AN EXTENSIVE SUBARACHNOID HEMORRHAGE (SAH) AT THE LEFT-MCA WAS NOTICED POST-OPERATIVELY. THE PT DEVELOPED HYDROCEPHALIA THAT ATTRIBUTED TO THE SAH. CONSERVATIVE MANAGEMENT OF SAH AND EXTERNAL VENTRICULAR DRAINAGE WAS PERFORMED FOR HYDROCEPHALIA. THE 28.0 MG OF TISSUE PLASMINOGEN ACTIVATOR (T-PA) WAS ADMINISTERED TO THE PT. AT 90 DAYS POST OPERATIVELY, PT HAD NOT RECOVERED AND HAD A MRS OF 5. THE PHYSICIAN BELIEVES THAT IT IS HIGHLY POSSIBLE THAT THE CAUSE OF THE SAH HAS BEEN DUE TO THE PULL-OUT FORCE ON PERFORATOR(S) DURING USE OF THE MERCI DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MERCI RETRIEVER V 3.0 FIRM CATHETER, PERCUTANEOUS NRY CONCENTRIC MEDICAL, INC. 90113 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other| R