BEUDAMED
    FDA Adverse Event Death Summary report: N

    MERCI RETRIEVER V 2.5 FIRM

    MDR report key: 2525507 · Received April 5, 2012

    Report

    Report Number
    2954917-2012-00036
    Event Type
    Death
    Date Received
    April 5, 2012
    Date of Event
    October 2, 2011
    Report Date
    April 5, 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

    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 PATIENT 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 THE CONCENTRIC MEDICAL, THE MANUFACTURING RECORDS FOR THE MERCI RETRIEVER V 2.5 FIRM DEVICE COULD NOT BE REVIEWED.

    Description of Event or Problem · 1

    PATIENT WAS A (B)(6) MALE WITH A LEFT MIDDLE CEREBRAL ARTERY (MCA) M1 OCCLUSION. PHYSICIAN MADE ONE PASS WITH A MERCI RETRIEVER V 2.5 FIRM. PATIENT HAD A THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) SCORE OF 3 AFTER TREATMENT. DURING PROCEDURE, A HEMORRHAGE WAS CONFIRMED AT PERFORATOR OF LEFT M1 REGION. AN EXTENSIVE SUBARACHNOID HEMORRHAGE WAS ALSO CONFIRMED AT POST-OPERATIVE CT SCAN. VENTRICULAR DRAINAGE WAS PERFORMED ON (B)(6) 2011, AS A MEDICAL INTERVENTION. ALSO, CEREBRAL DECOMPRESSION AND REMOVAL OF HEMATOMA WERE PERFORMED ON (B)(6) 2011, AS MEDICAL INTERVENTIONS. THE PATIENT EXPIRED ON (B)(6) 2011, DUE TO CEREBRAL EDEMA. ABOUT 49.3 MG OF TISSUE PLASMINOGEN ACTIVATOR (T-PA) WAS ADMINISTERED TO THE PATIENT DURING PROCEDURE. PHYSICIAN BELIEVES THAT THE CAUSE OF HEMORRHAGE WAS PROBABLY CAUSED BY PULLING FORCE TO PERFORATOR OR DAMAGE TO THE VESSEL WITH THE MERCI RETRIEVER, HOWEVER IT COULD NOT BE SPECIFIED. PHYSICIAN ALSO BELIEVES THAT THE PATIENT'S OUTCOME WAS ATTRIBUTED TO THE HEMORRHAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MERCI RETRIEVER V 2.5 FIRM CATHETER, PERCUTANEOUS NRY CONCENTRIC MEDICAL, INC. 90112 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death| O| R