BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONCERTO NYLON

    MDR report key: 8663165 · Received June 3, 2019

    Report

    Report Number
    2029214-2019-00509
    Event Type
    Malfunction
    Date Received
    June 3, 2019
    Date of Event
    November 21, 2018
    Report Date
    June 3, 2019
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    KRD
    UDI-DI
    00847536013346
    PMA / PMN Number
    K090046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THREE CONCERTO COILS (MODEL: NV-2-6-HELIX LOT: A648827) (PLI-10), (MODEL: NV-2-8-HELIX LOT: A673262) (PLI-20) AND (MODEL: NV-2-8-HELIX LOT: A578926) (PLI-30) WERE RETURNED FOR ANALYSIS WITHIN A SEALED TYVEK BIOHAZARD POUCH; WITHIN A SEALED POUCH BIOHAZARD BAG AND WITHIN AN OPENED CONCERTO IMPLANT COIL INNER POUCH. THE (TERUMO) 2.8F PROGREAT MICRO CATHETER WAS NOT RETURNED FOR ANALYSIS. THE MINIMUM ID (INNER DIAMETER) OF THE 2.8F PROGREAT MICRO CATHETER IS 0.027¿, AS PER AN ONLINE SOURCE. PER THE CONCERTO COIL IFU (INSTRUCTIONS FOR USE), THE MINIMUM CATHETER ID REQUIRED FOR USE IS 0.0165¿. THEREFORE, THE PROGREAT MICRO CATHETER IS COMPATIBLE FOR USE WITH THE CONCERTO COILS. THE FIRST CONCERTO IMPLANT COIL WAS RETURNED WITHOUT THE INTRODUCER SHEATH. THE CONCERTO IMPLANT COIL PUSHWIRE WAS FOUND TO BE BENT AT ~9.3CM, ~47.4CM AND AT ~88.5CM FROM PROXIMAL END. THE CONCERTO COIL WAS FOUND TO BE DETACHED. UNDER THE MICROSCOPE, THE COIN WAS NOT FOUND TO BE LOCATED AGAINST THE LUMEN STOP, AND THE SHIELD COIL WAS FOUND TO BE PRESENT. THE CONCERTO COIL COULD NOT BE USED FOR TESTING WITH AN IN-HOUSE MICROCATHETER DUE TO ITS DAMAGED CONDITION. ALL OTHER SUBASSEMBLIES APPEARED TO BE NORMAL AND NO OTHER ANOMALIES WERE OBSERVED. THE SECOND CONCERTO IMPLANT COIL WAS RETURNED WITHOUT THE INTRODUCER SHEATH. THE CO NCERTO IMPLANT COIL PUSHWIRE WAS FOUND TO BE BENT AT ~130.9CM FROM PROXIMAL END. THE CONCERTO COIL WAS FOUND TO BE STRETCHED AND DAMAGED. THE CONCERTO COIL COULD NOT BE USED FOR TESTING WITH AN IN-HOUSE MICROCATHETER DUE TO ITS DAMAGED CONDITION. ALL OTHER SUBASSE MBLIES APPEARED TO BE NORMAL AND NO OTHER ANOMALIES WERE OBSERVED. THE THIRD CONCERTO IMPLANT COIL WAS RETURNED WITHOUT THE INTRODUCER SHEATH. THE CONCERTO IMPLANT COIL PUSHWIRE WAS FOUND TO BE BENT AT ~7.6CM FROM PROXIMAL END. THE CONCERTO COIL WAS FOUND TO BE ST RETCHED AND DAMAGED. THE CONCERTO COIL COULD NOT BE USED FOR TESTING WITH AN IN-HOUSE MICRO CATHETER DUE TO ITS DAMAGED CONDITION. ALL OTHER SUBASSEMBLIES APPEARED TO BE NORMAL AND NO OTHER ANOMALIES WERE OBSERVED. THE CONCERTO COIL WAS RETURNED WITHOUT THE 2.8F PROGREAT MICRO CATHETER. THEREFORE, ANY CONTRIBUTING FACTORS (OTHER THAN INNER DIAMETER SPECIFICATION) FROM THE PROGREAT 2.8 MICRO CATHETER COULD NOT BE ASSESSED. FOR PLI-10 THE CONCERTO COIL WAS RETURNED WITHOUT THE INTRODUCER SHEATH. THE CONCERTO IMPLANT COIL PUSHWIRE WAS FOUND TO BE BENT. THE CONCERTO IMPLANT COIL WAS FOUND TO BE DETACHED. IT IS LIKELY THAT THE DAMAGE TO THE CONCERTO IMPLANT COIL PUSHWIRE OCCURRED DURING THE ATTEMPT TO PUSH THE COIL THROUGH THE MICRO CATHETER AGAINST THE REPORTED RESISTANCE. THE CONCERTO IMPLANT COIL WAS FOUND TO BE DETACHED AND DAMAGED. IT IS LIKELY THAT THE DAMAGE TO THE PUSHWIRE SUBSEQUENTLY CAUSED THE IMPLANT COIL TO DETACH. BASED ON THE DEVICE ANALYSIS AND REPORTED INFORMATION, THE CUSTOMER¿S REPORT OF ¿COIL KINK/DAMAGE¿ COULD NOT BE CONFIRMED AS THE IMPLANT COIL WAS FOUND TO BE DETACHED AND NOT RETURNED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED A REPORT THAT TWO OF THE NV-2-8-HELIXS WOULD NOT LOAD, AND A NV-2-6-HELIX WAS FRAYED. THE PATIENT UNDER WENT COILING TREATMENT OF Y90 MAPPING RIGHT HEPATIC. THE PATIENT'S BLOOD FLOW WAS NORMAL. THE VESSEL WAS NORMAL TORTUOUS. THERE WERE NO PATIENT SYMPTOMS ASSOCIATED WITH THE EVENT. THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE CATHETER WAS FLUSHED AS INDICATED PER THE IFU. THE COIL WAS HYDRATED PER THE IFU. PROGREAT 2.8 MICROCATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455122 CONCERTO NYLON DEVICE, EMBOLIZATION, VASCULAR KRD MICRO THERAPEUTICS, INC. DBA EV3 NV-2-8-HELIX A578926 00847536013346

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR