BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELAY NBS PLUS THORACIC STENT-GRAFT SYSTEM

    MDR report key: 15935722 · Received December 7, 2022

    Report

    Report Number
    2247858-2022-00192
    Event Type
    Malfunction
    Date Received
    December 7, 2022
    Date of Event
    November 13, 2022
    Report Date
    April 5, 2023
    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

    A DISSECTION PATIENT. AFTER THE SURGEON RELEASED THE RELAY NBS PRO, IT WAS FOUND THAT THE TIP HEAD END WAS DETACHED TO THE SYSTEM FLOATING AT THE ARCH OF THE THORACIC AORTA WHEN STAGE 4 MOTION WAS PRACTICED. AND IT COULD NOT BE PULLED OUT OF THE BODY WITH THE STEEL TOLL. FINALLY, A TRAP WAS PLACED ON THE SAME SIDE TO CAPTURE THE TIP HEAD END THROUGH THE SUPER-STIFF GUIDE WIRE LUNDERQUIST, AND THE TIP HEAD WAS PULLED OUT FROM THE FEMORAL ARTERY BUT CAUSED A SEVERE DAMAGE TO THE FEMORAL ARTERY ENTRANCE. WITH EXTRA PRESS ON THE SPOT, THE BLOOD DID NOT STOP. TO SOLVE THIS ISSUE, A VIABAHN STENT GRAFT WAS IMPLANTED. PATIENT OUTCOME: "ANOTHER STENT WAS IMPLANTED TO STOP BLEEDING."

    Description of Event or Problem · 0

    A DISSECTION PATIENT. AFTER THE SURGEON RELEASED THE RELAY NBS PRO, IT WAS FOUND THAT THE TIP HEAD END WAS DETACHED TO THE SYSTEM FLOATING AT THE ARCH OF THE THORACIC AORTA WHEN STAGE 4 MOTION WAS PRACTICED. AND IT COULD NOT BE PULLED OUT OF THE BODY WITH THE STEEL TOLL. FINALLY, A TRAP WAS PLACED ON THE SAME SIDE TO CAPTURE THE TIP HEAD END THROUGH THE SUPER-STIFF GUIDE WIRE LUNDERQUIST, AND THE TIP HEAD WAS PULLED OUT FROM THE FEMORAL ARTERY BUT CAUSED A SEVERE DAMAGE TO THE FEMORAL ARTERY ENTRANCE. WITH EXTRA PRESS ON THE SPOT, THE BLOOD DID NOT STOP. TO SOLVE THIS ISSUE, A VIABAHN STENT GRAFT WAS IMPLANTED. PATIENT OUTCOME: "ANOTHER STENT WAS IMPLANTED TO STOP BLEEDING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308510 RELAY NBS PLUS THORACIC STENT-GRAFT SYSTEM STENT, ENDOVASCULAR GRAFT, AORTIC MIH BOLTON MEDICAL, INC. B220503222

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female