BEUDAMED
    FDA Adverse Event Death Summary report: N

    MERCI RETRIEVER V 2.5 FIRM

    MDR report key: 1664835 · Received April 19, 2010

    Report

    Report Number
    2954917-2010-00005
    Event Type
    Death
    Date Received
    April 19, 2010
    Date of Event
    March 9, 2010
    Report Date
    April 16, 2010
    Manufacturer
    CONCENTRIC MEDICAL, INC.
    Product Code
    DQY
    PMA / PMN Number
    K081305
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT WAS AN (B) (6) FEMALE WITH COMPLETE THROMBOEMBOLIC OCCLUSION OF THE DISTAL MI SEGMENT OF THE RIGHT MIDDLE CEREBRAL ARTERY (MCA). THREE ATTEMPTS WERE MADE TO RETRIEVE THE OCCLUSION USING THREE DIFFERENT V RETRIEVER DEVICES. AFTER THE FIRST ATTEMPT, NO SIGNIFICANT IMPROVEMENT WAS NOTED. AFTER THE SECOND ATTEMPT, PARTIAL OPENING OF THE MCA WITH POSTERIOR DIVISION BRANCH FILLING WAS NOTED. HOWEVER, THERE WAS STILL SIGNIFICANT OCCLUSION OF THE REST OF THE MCA. AFTER THE THIRD ATTEMPT (USING V 2.5 FIRM DEVICE), AN ANGIOGRAM SHOWED CONTRAST MEDIA EXTRAVASATION SECONDARY TO MCA PERFORATION. THE PROCEDURE WAS TERMINATED. NO DEVICE MALFUNCTIONS WERE REPORTED. A POST-PROCEDURE CT SCAN SHOWED SUBARACHNOID HEMORRHAGE. THE PT EXPIRED 4 DAYS AFTER THE PROCEDURE DUE TO STROKE. THE RETRIEVER INSTRUCTIONS FOR USE (IFU) LISTS VESSEL PERFORATION, INTRACRANIAL HEMORRHAGE, NEUROLOGICAL DEFICITS INCLUDING STROKE; AND DEATH AS A POSSIBLE COMPLICATIONS. THE IFU ALSO CONTAINS A WARNING THAT PROVIDES RECOMMENDATIONS TO REDUCE THE RISK OF VESSEL DAMAGE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Death