BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERCI RETRIEVER L6

    MDR report key: 1300322 · Received January 28, 2009

    Report

    Report Number
    2954917-2009-00002
    Event Type
    Injury
    Date Received
    January 28, 2009
    Date of Event
    January 8, 2009
    Report Date
    January 26, 2009
    Manufacturer
    CONCENTRIC MEDICAL, INC.
    Product Code
    NRY
    PMA / PMN Number
    K071172
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NONE OF THE REPORTED INFORMATION SUGGESTED THAT ANY CONCENTRIC MEDICAL DEVICE MALFUNCTIONED. BECAUSE THE DEVICE WAS NOT RETURNED TO CONCENTRIC MEDICAL, A COMPLETE INVESTIGATION COULD NOT BE PERFORMED. THE CURRENT DEVICE INSTRUCTIONS FOR USE (IFU) LISTS VESSEL DISSECTION AND PERFORATION AS POSSIBLE PROCEDURAL COMPLICATIONS. ALSO, THERE IS A WARNING IN THE IFU THAT PROVIDES RECOMMENDATIONS TO PREVENT VESSEL DAMAGE.

    Description of Event or Problem · 1

    PHYSICIAN USED A MERCI RETRIEVER L6 FOR A CAROTID T OCCLUSION IN PT AND DEPLOYED THE DEVICE IN THE HORIZONTAL SECTION OF THE M1. IN WITHDRAWING DEVICE, HE MET RESISTANCE AND TORQUEED THE DEVICE AND PULLED RATHER FIRMLY. HE PULLED OUT WHAT HE BELIEVED TO BE CLOT AND ARTERIAL TISSUE. HE SENT THE SPECIMEN TO THE PATHOLOGY LAB, AND IT WAS DETERMINED THAT THE SPECIMEN INCLUDED SOME ARTERY LINING. HE WAS CONCERNED AS THE PT HAS RECEIVED IV TPA. HE OBTAINED A CT SCAN AND REVERSED ALL AGENTS ON BOARD (TPA, HEPARIN) TO PREVENT HEMORRHAGE. THE PT DID FINE AND THE CT SCAN WAS ONLY POSITIVE TO CONTRAST STAINING, NO BLOOD WAS SEEN. AS OF 2009, THE PT WAS IN THE ICU ON A VENTILATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MERCI RETRIEVER L6 CATHETER, THROMBUS RETRIEVER NRY CONCENTRIC MEDICAL, INC. 90060 NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention