BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERCI RETRIEVER L6

    MDR report key: 1371487 · Received February 10, 2009

    Report

    Report Number
    2954917-2009-00006
    Event Type
    Malfunction
    Date Received
    February 10, 2009
    Date of Event
    February 2, 2009
    Report Date
    February 9, 2009
    Manufacturer
    CONCENTRIC MEDICAL, INC.
    Product Code
    NRY
    PMA / PMN Number
    K071172
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INSTRUCTIONS FOR USE (IFU) INCLUDES A WARNING THAT PROVIDES RECOMMENDATIONS TO REDUCE THE RISK OF FRACTURE. IN PARTICULAR, IT IS RECOMMENDED THAT THE MICROCATHETER TIP POSITION BE MAINTAINED UP TO THE HELIX LOOPS DURING RETRIEVER MANIPULATION AND WITHDRAWAL. THE PROXIMAL END OF THE BROKEN DEVICE WAS RETURNED FOR ANALYSIS. THE RESULTS OF THE INVESTIGATION SHOWED THAT THE CORE WIRE FRACTURED PROXIMAL FROM THE PROXIMAL SIDE OF THE FILAMENT FUSING COIL. THE FILAMENT FUSING COIL IS LOCATED PROXIMAL TO THE DEVICE HELIX. THERE WAS LOCALIZED BENDING OF THE CORE WIRE ADJACENT TO THE FRACTURE SITE. BASED ON THE RESULTS OF THE INVESTIGATION AND THE INFO PROVIDED BY THE SITE, THIS FRACTURE MODE INDICATES THAT THE MICROCATHETER TIP POSITION WAS NOT MAINTAINED UP TO THE HELIX LOOPS DURING RETRIEVER MANIPULATION AND WITHDRAWAL AS INDICATED IN THE IFU. THERE WAS NO EVIDENCE TO SUGGEST THAT THE RETRIEVER L6 FAILED TO MEET SPECIFICATIONS BEFORE DISTRIBUTION. THE MANUFACTURING RECORDS FOR RETRIEVER L6 DEVICE, LOT NUMBER 33188, WAS REVIEWED AND NO ANOMALIES WERE FOUND THAT ARE RELATED TO THIS COMPLAINT.

    Description of Event or Problem · 1

    A FEMALE, PRESENTED WITH LEFT MCA OCCLUSION. THE PT HAD A NIHSS SCORE OF 18 AND APPEARED APHASIC. A RETRIEVER L6 WAS USED FOR ONE PASS BUT WITHOUT SUCCESS (TIMI 1 FLOW). A NEW (SECOND) RETRIEVER L6 WAS USED FOR SECOND PASS. THE DEVICE FRACTURED DURING WITHDRAWAL, LEAVING A DISTAL END OF THE DEVICE IN THE VESSEL. THE PHYSICIAN USED A RETRIEVER V 2.5 FIRM AND RETRIEVER V 3.0 FIRM TO ATTEMPT TO RETRIEVE THE L6 FRAGMENT BUT WAS NOT SUCCESSFUL. THE VESSEL STARTED TO HEMORRHAGE AT THE SITE OF THE OCCLUSION, NOT THE FRACTURE. THE BLEEDING SEEMED TO STOP AFTER A FEW MINUTES. THE PT EXPIRED 18 HOURS POST-PROCEDURE. NO SPECIFIC INFO WAS RECEIVED REGARDING RETRIEVER TORQUING OR MICROCATHETER POSITION DURING USE TO DETERMINE IF THE IFU RECOMMENDATIONS TO PREVENT FRACTURE WERE FOLLOWED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MERCI RETRIEVER L6 CATHETER, THROMBUS RETRIEVER NRY CONCENTRIC MEDICAL, INC. 90060 33188

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other