BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELAY NBS THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM

    MDR report key: 15078816 · Received July 21, 2022

    Report

    Report Number
    2247858-2022-00106
    Event Type
    Injury
    Date Received
    July 21, 2022
    Date of Event
    July 13, 2022
    Report Date
    September 1, 2022
    Manufacturer
    BOLTON MEDICAL, INC.
    Product Code
    MIH
    PMA / PMN Number
    P110038
    Adverse Event
    Yes
    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

    "PATIENT WAS DIAGNOSED AS THORACIC AORTIC DISSECTION. AFTER THE SURGEON RELEASED THE RELAY NBS PLUS AT STAGE 4, IT FELT NOT FLUENTLY TO RETRACT, AND JUST AT THE POSITION OF NEAR THE FEMORAL ARTERY WHEN CONTINUE TO PULL THE TIP, THE TIP COLLAPSED AND FAILED TO PULL OUT WITH THE DELIVERY SYSTEM." PATIENT OUTCOME - "HAD TO UNDERGO THE OPEN SURGERY TO TAKE TO TAKE THE TIP OUT. CAUSED A GREAT DAMAGE TO PATIENT'S FEMORAL AND ILIAC VESSELS."

    Description of Event or Problem · 0

    "PATIENT WAS DIAGNOSED AS THORACIC AORTIC DISSECTION. AFTER THE SURGEON RELEASED THE RELAY NBS PLUS AT STAGE 4, IT FELT NOT FLUENTLY TO RETRACT, AND JUST AT THE POSITION OF NEAR THE FEMORAL ARTERY WHEN CONTINUE TO PULL THE TIP, THE TIP COLLAPSED AND FAILED TO PULL OUT WITH THE DELIVERY SYSTEM." PATIENT OUTCOME - "HAD TO UNDERGO THE OPEN SURGERY TO TAKE TO TAKE THE TIP OUT. CAUSED A GREAT DAMAGE TO PATIENT'S FEMORAL AND ILIAC VESSELS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607473 RELAY NBS THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM STENT, ENDOVASCULAR GRAFT, AORTIC MIH BOLTON MEDICAL, INC. B211002004

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Required Intervention