BEUDAMED
    FDA Adverse Event Death Summary report: N

    MERCI RETRIEVER V 2.5 SOFT

    MDR report key: 2642516 · Received July 2, 2012

    Report

    Report Number
    2954917-2012-00063
    Event Type
    Death
    Date Received
    July 2, 2012
    Date of Event
    June 18, 2011
    Report Date
    July 2, 2012
    Manufacturer
    CONCENTRIC MEDICAL, INC.
    Product Code
    NRY
    PMA / PMN Number
    K081305
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH CEREBRAL DECOMPRESSION WAS PERFORMED FOR THE SAH, THE ORIGINAL INFARCTION AT LEFT MCA REGION WORSENED AND THE PT PASSED AWAY. THERE WAS NO EVIDENCE 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, 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 2.5 SOFT DEVICE COULD NOT BE REVIEWED.

    Description of Event or Problem · 1

    PLEASE REFER TO MEDWATCH MFR REPORT NUMBER 2954917-2012-00062. THIS REPORT IS FOR THE SECOND DEVICE INVOLVED IN THE CASE. PT WAS A (B)(6) FEMALE WITH LEFT MIDDLE CEREBRAL ARTERY (MCA) M1 OCCLUSION. ONE PASS WITH A MERCI RETRIEVER V 2.0 FIRM RETRIEVER, TWO PASSES WITH A MERCI RETRIEVER V 2.5 SOFT AND TWO PASSES WITH A MERCI RETRIEVER V 2.5 FIRM WERE MADE. PT HAD A THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) SCORE OF 2A AFTER TREATMENT. SUBARACHNOID HEMORRHAGE (SAH) WAS CONFIRMED AT LEFT SYLVIAN FISSURE RIGHT AFTER PROCEDURE. LATER, THE SAH EXPANDED AND INCREASED IN SEVERITY. ON (B)(6), CEREBRAL DECOMPRESSION WAS PERFORMED AND INTRAOPERATIVE FINDING SHOWED DAMAGE TO PERFORATOR OF M2 BY PULLOUT FORCE. PT EXPIRED ON (B)(6) 2011. TISSUE PLASMINOGEN ACTIVATOR (T-PA) WAS NOT ADMINISTERED TO THE PT DURING PROCEDURE. CEREBRAL DECOMPRESSION WAS PERFORMED AS MEDICAL INTERVENTION FOR SAH. PHYSICIAN BELIEVES THAT THE SAH IS DUE TO PULLOUT FORCE APPLIED TO THE VESSEL DURING PROCEDURE WITH THE MERCI RETRIEVER. PHYSICIAN BELIEVES THAT THIS ATTRIBUTED TO SERVE CURVATURE OF THE PT'S VESSEL (LEFT M1).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MERCI RETRIEVER V 2.5 SOFT CATHETER, PERCUTANEOUS NRY CONCENTRIC MEDICAL, INC. 90111 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death| R