BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERCI RETRIEVER V 2.0 FIRM

    MDR report key: 2505140 · Received March 21, 2012

    Report

    Report Number
    2954917-2012-00023
    Event Type
    Malfunction
    Date Received
    March 21, 2012
    Date of Event
    March 9, 2010
    Report Date
    March 21, 2012
    Manufacturer
    CONCENTRIC MEDICAL, INC.
    Product Code
    NRY
    PMA / PMN Number
    K090085
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CURRENT DEVICE INSTRUCTIONS FOR USE (IFU) LISTS A WARNING IN THE IFU THAT PROVIDES RECOMMENDATIONS TO REDUCE THE RISK OF FRACTURE.

    Description of Event or Problem · 1

    PATIENT WAS A (B)(6) MALE WITH A HISTORY OF A GRADE 5 LEFT TEMPORAL ARTERIOVENOUS MALFORMATION WHO HAD PREVIOUS COILING OF FLOW RELATED ANEURYSMS IN THE ANTERIOR COMMUNICATION ARTERY. SINCE THE LAST PROCEDURE, PATIENT DEVELOPED TWO NEW FLOW-RELATED ANEURYSMS. DURING COILING OF THE SECOND ANEURYSM A COIL DISLODGED TO THE LEFT A2 VESSEL. DURING THE REMOVAL ATTEMPT OF THE COIL, COIL MIGRATED TO THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) AND WAS UNABLE TO BE REMOVED. MULTIPLE ATTEMPTS WERE MADE WITH 2 MM AND 4 MM SNARE DEVICES, A 2 MM ALLIGATOR DEVICE AND A MERCI RETRIEVER V 2.0 FIRM, THE RETRIEVER BROKE IN THE RIGHT MIDDLE CEREBRAL VESSEL. THEN A MERCI RETRIEVER V 2.5 FIRM WAS USED IN AN ATTEMPT TO REMOVE THE RETRIEVER V 2.0 FIRM AS WELL AS THE COIL FROM THE MCA. THIS V RETRIEVER ALSO BROKE. A 2 MM SNARE WAS ADVANCED THROUGH EXCELSIOR SL 10 MICROCATHETER INTO THE PROXIMAL RIGHT MCA. THIS SNARE WAS ABLE TO REMOVE THE MOST PROXIMAL MERCI RETRIEVER FROM THE RIGHT MCA. HOWEVER, THE FIRST MERCI RETRIEVER V 2.0 FIRM AND THE COIL REMAINED WITHIN THE MID M1 SEGMENT OF THE RIGHT MCA WITH RESULTANT OCCLUSION OF DISTAL FLOW. A 100 GRAMS OF MANNITOL WERE ADMINISTERED INTO THE PATIENT AND UPON NORMALIZATION OF ACT, THE PATIENT WAS TRANSFERRED EMERGENTLY TO THE OPERATING ROOM FOR RIGHT CRANIECTOMY, ARTERIOTOMY AND REMOVAL OF FOREIGN BODY UNDER DIRECT VISUALIZATION. POST RIGHT HEMICRANIECTOMY, THERE WAS EVIDENCE OF SMALL UNDERLYING RIGHT SUBDURAL HEMORRHAGE AS WELL AS DIFFUSE SULCAL EFFACEMENT WITH DIFFUSE SULCAL AND BASILAR CISTERN SUBARACHNOID HEMORRHAGE. 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 MANUFACTURING RECORDS FOR THE MERCI RETRIEVER V 2.0 FIRM DEVICE COULD NOT BE REVIEWED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MERCI RETRIEVER V 2.0 FIRM CATHETER, PERCUTANEOUS NRY CONCENTRIC MEDICAL, INC. 90110 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other| R