BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERCI RETRIEVER V 3.0 FIRM

    MDR report key: 2193172 · Received July 21, 2011

    Report

    Report Number
    2954917-2011-00014
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    May 25, 2011
    Report Date
    July 21, 2011
    Manufacturer
    CONCENTRIC MEDICAL, INC.
    Product Code
    NRY
    PMA / PMN Number
    K090085
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFG RECORDS FOR MERCI RETRIEVER V 3.0 FIRM, LOT NUMBER 34732 WERE REVIEWED AND NO ANOMALIES WERE FOUND THAT ARE RELATED TO THIS COMPLAINT. 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 ALSO MAY HAVE CAUSED OR CONTRIBUTED TO THE OUTCOME.

    Description of Event or Problem · 1

    THIS REPORT IS BEING SUBMITTED FOR MERCI RETRIEVER V 3.0 FIRM DEVICE. A SEPARATE 30-DAY MEDWATCH MFR 2954917-2011-00011 WAS SUBMITTED FOR MERCI RETRIEVER V 2.5 SOFT DEVICE ON (B)(4) 2011. PT WAS A (B)(6) FEMALE WHO HAD A STROKE WITH A LARGE PROXIMAL MI OCCLUSION. PHYSICIAN FIRST STARTED USING A MERCI RETRIEVER V 3.0 FIRM WITH MERCI DISTAL ACCESS CATHETER (DAC) 044 (MFG BY CONCENTRIC MEDICAL). AFTER DEPLOYING THE DEVICE, THE PHYSICIAN MADE 2 QUARTER TURNS TO TORQUE. PHYSICIAN SAID THAT THE CLOT WAS VERY HARD AND PROBABLY HAD AN UNDERLYING STENOSIS. WHEN TRYING TO RETRIEVE THE RETRIEVER, IT WOULD NOT COME OUT. THE RETRIEVER THEN BROKE NEAR THE JUNCTION PROXIMAL TO THE LOOPS. HE THEN TRIED TO RETRIEVE THE BROKEN RETRIEVER TIP WITH A MERCI RETRIEVER V 2.5 SOFT. AT THS POINT, THE V 2.5 SOFT RETRIEVER GOT ENSNARED AND BROKE AS WELL. THE V 2.5 SOFT BROKE ON THE CORE WIRE APPROX. 10CM FROM THE LOOPS, NEAR THE INTERNAL CAROTID ARTERY (ICA) SIPHON. PHYSICIAN WAS NOT ABLE TO RETRIEVE THE BROKEN RETRIEVER EVEN AFTER ENGAGING THE WIRE WITH A SNARE. PHYSICIAN STATED THAT THE PT WAS NOT DOING WELL BECAUSE OF THE MASSIVE STROKE, BUT THAT SHE WAS DOING NO WORSE DUE TO THE DEVICE FAILURE.

    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 34732

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other