BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERCI RETRIEVEER L5

    MDR report key: 2492269 · Received March 13, 2012

    Report

    Report Number
    2954917-2012-00021
    Event Type
    Injury
    Date Received
    March 13, 2012
    Report Date
    March 13, 2012
    Manufacturer
    CONCENTRIC MEDICAL, INC.
    Product Code
    NRY
    PMA / PMN Number
    K062046
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IN CONCLUSION, THE ARTICLE STATED THAT THE PT WAS NOT SUITED FOR THROMBOLYTIC TREATMENT AND THAT THE USE OF THE MERCI DEVICE ALLOWED FOR A FAVORABLE CLINICAL OUTCOME THAN WOULD HAVE OTHERWISE BEEN ACHIEVED. PT HAD A FAVORABLE CLINICAL OUTCOME AT 90 DAYS (MRS = 2). THERE WAS NO EVIDENCE OF CONCENTRIC MEDICAL DEVICE MALFUNCTION AND 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., PATIENT FACTORS, DEVICE USE FACTORS, OTHER DEVICES EMPLOYED, DRUGS ADMINISTERED, ETC.) THAT ALSO MAY HAVE CAUSED OR CONTRIBUTED TO THE OUTCOME. 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 MFG RECORDS FOR THE MERCI L5 RETRIEVER DEVICE COULD NOT BE REVIEWED.

    Description of Event or Problem · 1

    THE FOLLOWING EVENT WAS CAPTURED FROM A JOURNAL ARTICLE. SOURCE: JOURNAL ARTICLE IN AUSTRALIAN INSTITUTE OF RADIOGRAPHY ¿ APRIL 2009; 56 (2): 27-33 TITLE: DELAYED TREATMENT FOR A CASE OF ACUTE ISCHAEMIC STROKE USING MECHANICAL EMBOLECTOMY ¿ THE L5 MERCI RETRIEVER. THE ARTICLE REPORTS THE USE OF A MERCI L5 RETRIEVER FOR A MIDDLE CEREBRAL ARTERY (MCA) OCCLUSION, RESULTING IN A TIMI 3 FLOW. AFTER THE SECOND PASS WITH THE MERCI RETRIEVER, A NEW OCCLUSION WAS OBSERVED IN THE PROXIMAL LEFT ANTERIOR CEREBRAL ARTERY (LACA). THE AUTHORS BELIEVE THAT THE NEW OCCLUSION MAY HAVE BEEN DUE TO A PROCEDURAL THROMBOEMBOLIC EVENT (CLOT FORMATION ON CATHETERS/GUIDEWIRES AND SUBSEQUENT EMBOLIZATION), OR EMBOLIZATION OF A FRAGMENT OF THE ORIGINAL THROMBUS AS IT WAS BEING REMOVED. IA TPA WAS ADMINISTERED TO LYSE THE CLOT. SIGNIFICANT VASOSPASM WAS ALSO NOTED WHICH WAS RESOLVED BY INFUSION OF GLYCERYL TRINITRATE (GTN) INTO THE ARTERY. AUTHORS ALSO NOTED SOME CONTRAST EXTRAVASATION POST-PROCEDURE WHICH THEY DESCRIBED AS REPERFUSION INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MERCI RETRIEVEER L5 CATHETER, THROMBUS RETRIEVER NRY CONCENTRIC MEDICAL, INC. 90050 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other| R