BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELAY NBS THORACIC STENT GRAFT WITH PLUS DELIVERY SYSTEM

    MDR report key: 15495296 · Received September 27, 2022

    Report

    Report Number
    2247858-2022-00137
    Event Type
    Malfunction
    Date Received
    September 27, 2022
    Date of Event
    August 12, 2022
    Report Date
    October 26, 2022
    Manufacturer
    BOLTON MEDICAL, INC.
    Product Code
    MIH
    PMA / PMN Number
    P110038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BOLTON MEDICAL IS VOLUNTARILY REPORTING AN EVENT RELATED TO A RELAY NBS THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM. THE RELAY NBS PLUS DEVICE IS NOT MARKETED IN THE US, HOWEVER IT IS SIMILAR TO THE RELAY PLUS THORACIC STENT GRAFT SYSTEM APPROVED FOR SALE IN THE US (P110038). THE EVENT OCCURRED IN CHINA.

    Additional Manufacturer Narrative · 0

    BOLTON MEDICAL IS VOLUNTARILY REPORTING AN EVENT RELATED TO A RELAY NBS THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM. THE RELAY NBS PLUS DEVICE IS NOT MARKETED IN THE US, HOWEVER IT IS SIMILAR TO THE RELAY PLUS THORACIC STENT GRAFT SYSTEM APPROVED FOR SALE IN THE US (P110038). THE EVENT OCCURRED IN CHINA.

    Description of Event or Problem · 0

    THE PATIENT WAS DIAGNOSED WITH TYPE B DISSECTION. THE SURGEON PERFORMED THE SURGERY UNDER IFU, BUT AFTER RELEASED THE RELAY NBS PLUS, THE STENT GRAFT, WHEN IT CAME TO STAGE 4, PULLED THE TIP BACK TO THE OUTER SHEATH, IT WAS NOT SMOOTHLY, HOWEVER, WITHDREW TO THE OUTER SHEATH BEFORE REMOVE THE DELIVERY SYSTEM, COULDN'T REMOVE WITH THE PLUS DELIVERY SYSTEM. THE SURGEON HAD TO USE A SNARE TO CAPTURE THE TIP HEAD CUT THE VESSEL OPEN, CAUSED AN UNNECESSARY DAMAGE TO THE PATIENT, SO THE SURGEON COMPLAINT ABOUT THE QUALITY OF RELAY NBS PLUS. PATIENT OUTCOME - UNKNOWN.

    Description of Event or Problem · 0

    THE PATIENT WAS DIAGNOSED WITH TYPE B DISSECTION. THE SURGEON PERFORMED THE SURGERY UNDER IFU, BUT AFTER RELEASED THE RELAY NBS PLUS, THE STENT GRAFT, WHEN IT CAME TO STAGE 4, PULLED THE TIP BACK TO THE OUTER SHEATH, IT WAS NOT SMOOTHLY, HOWEVER, WITHDREW TO THE OUTER SHEATH BEFORE REMOVE THE DELIVERY SYSTEM, COULDN'T REMOVE WITH THE PLUS DELIVERY SYSTEM. THE SURGEON HAD TO USE A SNARE TO CAPTURE THE TIP HEAD CUT THE VESSEL OPEN, CAUSED AN UNNECESSARY DAMAGE TO THE PATIENT, SO THE SURGEON COMPLAINT ABOUT THE QUALITY OF RELAY NBS PLUS. PATIENT OUTCOME - UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1747542 RELAY NBS THORACIC STENT GRAFT WITH PLUS DELIVERY SYSTEM STENT, ENDOVASCULAR GRAFT, AORTIC MIH BOLTON MEDICAL, INC. B210922315

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Required Intervention