BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMANECI 17

    MDR report key: 16085192 · Received January 3, 2023

    Report

    Report Number
    3009957947-2023-00001
    Event Type
    Injury
    Date Received
    January 3, 2023
    Date of Event
    August 29, 2022
    Report Date
    January 3, 2023
    Manufacturer
    RAPID-MEDICAL LTD
    Product Code
    PUU
    UDI-DI
    07290015107150
    PMA / PMN Number
    DEN17064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THROMBUS FORMATION IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH THE USE OF COIL EMBOLIZATION ASSIST DEVICES, INCLUDING COMANECI DEVICE. THE IFU IDENTIFIES THROMBUS AS POTENTIAL COMPLICATIONS ASSOCIATED WITH USE OF THE DEVICE.

    Description of Event or Problem · 0

    THE FOLLOWING EVENT WAS REPORTED THROUGHOUT THE SUCCESS POST MARKET SURVEILLANCE STUDY. THE PATIENT WAS TREATED FOR RIGHT MIDDLE CEREBRAL ARTERY ANEURYSM COIL EMBOLIZATION WITH THE COMANECI 17 AS COIL EMBOLIZATION ASSIST DEVICE. WHILE PLACING THE EMBOLIZATION COIL INSIDE THE ANEURYSM THE PHYSICIAN NOTICED A THROMBUS FORMING WITHIN THE COMANECI STENT. THE PHYSICIAN STOPPED THE COILING AND REMOVED THE COMANECI AND THE MICROCATHETERS FROM THE PATIENT'S ANATOMY. A FOLLOW UP CONTRAST RUN STILL SHOWED SOME SLOW FILLING OF THE DISTAL RIGHT M3/M4 BRANCHES, THEREFORE, A MEDICATION WAS ADMINISTRATED, AND A FOLLOW UP CONTRAST RUN SHOWED NORMAL DISTAL PERFUSION WITHOUT EVIDENCE OF DISTAL THROMBOEMBOLISM. A NEUROLOGICAL EXAM WAS PERFORMED 19 DAYS POST PROCEDURE, THE PATIENT WAS CLINICALLY ASYMPTOMATIC AND HAD NO CLINICAL SEQUELAE, MRS SCORE WAS 0.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507973 COMANECI 17 COMANECI EMBOLIZATION ASSISST DEVICE PUU RAPID-MEDICAL LTD ANPP7199 211224CS01 07290015107150

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Required Intervention