BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERCI RETRIEVER V 2.0 SOFT

    MDR report key: 2484638 · Received March 7, 2012

    Report

    Report Number
    2954917-2012-00016
    Event Type
    Injury
    Date Received
    March 7, 2012
    Date of Event
    October 19, 2011
    Report Date
    March 7, 2012
    Manufacturer
    CONCENTRIC MEDICAL, INC.
    Product Code
    NRY
    PMA / PMN Number
    K082034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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

    PT WAS A (B)(6) MALE WITH A RIGHT INTERNAL CAROTID ARTERY (ICA) M1 OCCLUSION. A MERCI RETRIEVER V 2.0 SOFT WAS SUCCESSFULLY USED TO RECANALIZE THE VESSEL ACHIEVING A THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) SCORE OF 2B. DURING PROCEDURE, AN OCCLUSION OF PERIPHERAL RIGHT ARTERIA GYRI ANGULARIS WAS NOTICED. AN ASYMPTOMATIC HEMORRHAGE LOCALIZED TO RIGHT MIDDLE CEREBRAL ARTERY MCA AND RIGHT ICA REGION WAS CONFIRMED A DAY AFTER OPERATION, WHICH DISAPPEARED 5 DAYS POST OPERATIVELY. TISSUE PLASMINOGEN ACTIVATOR (T-PA) WAS NOT ADMINISTERED DURING PROCEDURE. ALSO, NO MEDICAL INTERVENTION WAS REQUIRED. PHYSICIAN BELIEVES THAT THE CAUSE OF THE OCCLUSION IS CONSIDERED TO HAVE BEEN DUE TO SCATTERED CLOT THAT HAD NOT BEEN FULLY RETRIEVED WITH THE MERCI RETRIEVER. PHYSICIAN BELIEVES THAT THE HEMORRHAGE IS ATTRIBUTED TO DAMAGE TO THE VESSEL WITH MERCI RETRIEVER. PHYSICIAN ALSO STATED THAT THE PT'S AGE, TORTUOSITY OF THE DAMAGED ICA AND ARTERIAL SCLEROSIS SEEMED TO CONTRIBUTED TO THE HEMORRHAGE. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MERCI RETRIEVER V 2.0 SOFT CATHETER, PERCUTANEOUS NRY CONCENTRIC MEDICAL, INC. 90109 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Other