BEUDAMED
    FDA Adverse Event Death Summary report: N

    MERCI RETRIEVER V 3.0 FIRM

    MDR report key: 1676926 · Received May 5, 2010

    Report

    Report Number
    2954917-2010-00007
    Event Type
    Death
    Date Received
    May 5, 2010
    Date of Event
    April 15, 2010
    Report Date
    May 5, 2010
    Manufacturer
    CONCENTRIC MEDICAL, INC.
    Product Code
    NRY
    PMA / PMN Number
    K082034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BECAUSE THE DEVICE WAS NOT RETURNED TO CONCENTRIC MEDICAL, A COMPLETE INVESTIGATION COULD NOT BE PERFORMED. THE MFG RECORDS FOR MERCI RETRIEVER V 3.0 FIRM, LOT #, 33717, WERE REVIEWED AND NO ANOMALIES WERE FOUND THAT ARE RELATED TO THIS COMPLAINT.

    Description of Event or Problem · 1

    THE RIGHT CAROTID ARTERY WAS EXTREMELY TORTUOUS WITH ATHEROMA THAT WAS ALMOST COMPLETELY OCCLUSIVE. A 9F BGC WAS USED FOR PROXIMAL PROTECTION DURING STENT PLACEMENT IN THE RIGHT CAROTID ARTERY OCCLUSION. FLOW WAS RESTORED IN THE RIGHT CAROTID ARTERY. CLOT WAS LOCATED IN M1 SEGMENT OF RIGHT MCA. THERE WAS VERY LITTLE COLLATERAL FLOW. DISTAL ACCESS CATHETER (DAC 057), A MICROCATHETER 18L AND A HEADLINER GUIDEWIRE WERE USED TO ACCESS THE CLOT. RETRIEVER V 3.0 FIRM WAS USED TO TRY TO REMOVE THE M1 CLOT. THE PHYSICIAN ENCOUNTERED DIFFICULTY WITHDRAWING THE RETRIEVER FROM THE MCA. THE DISTAL LOOP OF THE RETRIEVER RETAINED ITS SHAPE AND WOULD NOT RESHEATH INTO THE MICROCATHETER OR THE DISTAL ACCESS CATHETER, NOR COULD THE RETRIEVER BE WITHDRAWN FROM THE VESSEL. THE PHYSICIAN THOUGHT THE RETRIEVER GOT CAUGHT ON ATHEROMA IN THE MCA. THE RETRIEVER WAS PURPOSELY OVER-TORQUED TO BREAK IT, AND A SNARE WAS USED TO TRY TO RETRIEVE THE BROKEN DEVICE. THE SNARE ENGAGED THE RETRIEVER, BUT THE SNARE COULD NOT BE WITHDRAWN, SO THE SNARE WAS LEFT IN PLACE. THE PT SUBSEQUENTLY EXPIRED FROM THE STROKE. THE PHYSICIAN STATED THAT THE DIFFICULTIES WITH THE RETRIEVER DID NOT ALTER THE OUTCOME OF THE PT. THERE WAS NO EVIDENCE OF CONCENTRIC MEDICAL DEVICE MALFUNCTION AND THE DEVICE INSTRUCTIONS FOR USE LISTS RELATED POSSIBLE COMPLICATIONS.

    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 33717

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Death| R