BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERCI RETRIEVER L4

    MDR report key: 1030421 · Received April 17, 2008

    Report

    Report Number
    2954917-2008-00004
    Event Type
    Malfunction
    Date Received
    April 17, 2008
    Date of Event
    March 25, 2008
    Report Date
    April 16, 2008
    Manufacturer
    CONCENTRIC MEDICAL, INC.
    Product Code
    NRY
    PMA / PMN Number
    K070521
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING RECORDS FOR ALL RETRIEVER L4 DEVICE LOTS SHIPPED TO THE SITE (LOT NUMBERS 32925, 32935, 33028, 33054) WERE REVIEWED AND NO ANOMALIES WERE FOUND THAT ARE RELATED TO THIS COMPLAINT. THE DEVICE INSTRUCTIONS FOR USE (IFU) INCLUDES THE FOLLOWING WARNINGS RELATED TO FRACTURES. TO REDUCE RISK OF FRACTURE, ADHERE TO THE FOLLOWING RECOMMENDATIONS: IMMEDIATELY AFTER UNSHEATHING ALL RETRIEVER LOOPS, POSITION MICROCATHETER TIP MARKER JUST PROXIMAL TO LOOPS. MAINTAIN MICROCATHETER TIP MARKER JUST PROXIMAL TO RETRIEVER LOOPS DURING MANIPULATION AND WITHDRAWAL. DO NOT ROTATE RETRIEVER MORE THAN 5 REVOLUTIONS. DO NOT WITHDRAW RETRIEVER L SERIES INTO MICROCATHETER AFTER RETRIEVER DEPLOYMENT INTO VESSEL. DO NOT USE RETRIEVER L SERIES FOR MORE THAN TWO (2) RETRIEVAL ATTEMPTS. A RETRIEVAL ATTEMPT IS ONE ADVANCEMENT AND COMPLETE WITHDRAWAL CYCLE. THE INVESTIGATION ON THE RETURNED DEVICE SHOWED THAT CORE WIRE FRACTURED ABOUT 10 MM PROXIMAL FROM THE PROXIMAL SOLDER JOINT THAT CONNECTS THE PLATINUM COIL TO THE CORE WIRE. SCANNING ELECTRON MICROGRAPH IMAGES OF THE FRACTURE FACE WERE REVIEWED BY OUR CONSULTING METALLURGIST. HE INDICATED THAT THE PRIMARY MODE OF FRACTURE APPEARED TO BE TORSIONAL LOADING. FROM REVIEW OF INFORMATION RECEIVED REGARDING HOW THE DEVICE WAS USED, IT APPEARS THAT IFU WARNINGS #3 AND #4 (SHOWN ABOVE) WERE NOT ABIDED BY.

    Description of Event or Problem · 1

    THE PATIENT WAS MALE PATIENT WITH AN ACUTE ISCHEMIC STROKE AND AN NIHSS SCORE OF 24. ON THE THIRD RETRIEVER PASS USING THE SAME RETRIEVER L4, THE PHYSICIAN NOTED RESISTANCE WHILE RETRACTING IT FROM THE INFERIOR BRANCH OF THE M2 INTO THE M1 ARTERY. UPON ENCOUNTERING THIS RESISTANCE, THE PHYSICIAN PERFORMED MANIPULATIONS INCLUDING RETRACTION, ATTEMPTED RESHEATHING AND READVANCING THE RETRIEVER, BUT HE WAS UNABLE TO FREE THE RETRIEVER. EVENTUALLY, FOLLOWING THE VARIOUS MANIPULATIONS OF THE DEVICE, THE CORE WIRE FRACTURED LEAVING A FRACTURED RETRIEVER TIP/WIRE IN THE CLOT IN THE M1 ARTERY. THE PHYSICIAN MADE AN ATTEMPT TO USE A SNARE TO RETRIEVE THE FRACTURED TIP. HE WAS ABLE TO SNARE AND RETRIEVE A PORTION OF THE FRACTURED DEVICE, BUT PART OF THE DISTAL FRACTURED TIP REMAINED IMBEDDED IN THE CLOT IN THE M1 ARTERY. THE PATIENT'S M1 REMAINED OCCLUDED. THE PATIENT HAD A SLIGHTLY IMPROVED NIHSS SCORE OF 20 AFTER THE CASE. THE PHYSICIAN FEELS THE PATIENT'S CONDITION DID NOT WORSEN FROM THE ATTEMPTED EMBOLECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MERCI RETRIEVER L4 CATHETER, THROMBUS RETRIEVER NRY CONCENTRIC MEDICAL, INC. 90070 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other