BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERCI RETRIEVER V 3.0 FIRM

    MDR report key: 2180852 · Received April 29, 2011

    Report

    Report Number
    2954917-2011-00006
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    April 15, 2011
    Report Date
    April 29, 2011
    Manufacturer
    CONCENTRIC MEDICAL, INC.
    Product Code
    NRY
    PMA / PMN Number
    K090085
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 ALSO MAY HAVE CAUSED OR CONTRIBUTED TO THE OUTCOME.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PT PRESENTED VERY WELL ORGANIZED OCCLUSION IN ICA. THE PHYSICIAN NOTED THAT THE PT HAD TORTUOUS ICA. WHILE PHYSICIAN WAS USING A MERCI RETRIEVER V 3.0 FIRM, THE RETRIEVER TIP SNAPPED AND GOT STUCK IN CLOT AT THE END OF THE ICA/M1 SEGMENT. PHYSICIAN STATED THAT HE HAD TO PULL PRETTY HARD TO TRY AND REMOVE THE RETRIEVER FROM CLOT AND THAT HE WAS ALSO USING A PENUMBRA SYSTEM FOR PROXIMAL ASPIRATION. PHYSICIAN BELIEVED THAT THE RETRIEVER FRACTURE WAS DUE TO TOO MUCH FORCE USED DURING THE CASE. PHYSICIAN SUCCESSFULLY REMOVED THE RETRIEVER TIP FROM THE PT USING A 4MM MICROSNARE. NO PT COMPLICATIONS WERE REPORTED. PER PHYSICIAN, THE PT'S FINAL OUTCOME WAS OKAY AND THERE WERE NO ISSUES OTHER THAN THE ORIGINAL STROKE. SINCE THE DEVICE WAS NOT RETURNED TO CONCENTRIC MEDICAL, A COMPLETE INVESTIGATION COULD NOT BE PERFORMED. THE DEVICE INSTRUCTIONS FOR USE (IFU) INCLUDES A WARNING THAT PROVIDES RECOMMENDATIONS TO REDUCE THE RISK OF FRACTURE.

    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 Required Intervention