BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELAY NBS THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM

    MDR report key: 11588398 · Received March 30, 2021

    Report

    Report Number
    2247858-2021-00033
    Event Type
    Malfunction
    Date Received
    March 30, 2021
    Date of Event
    March 3, 2021
    Report Date
    September 21, 2021
    Manufacturer
    BOLTON MEDICAL, INC.
    Product Code
    MIH
    PMA / PMN Number
    P110038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BOLTON MEDICAL IS VOLUNTARILY REPORTING A DEVICE MALFUNCTION RELATED TO THE RELAY NBS PLUSTHORACIC STENT-GRAFT SYSTEM. THE RELAY NBS PLUS DEVICE IS NOT MARKETED IN THE US, HOWEVER IT IS SIMILAR TO THE RELAY THORACIC STENT GRAFT WITH PLUS DELIVERY SYSTEM APPROVED FOR SALE IN THE US IN 2012 (P110038). THE RELAY NBS PLUS RELATED EVENT OCCURRED IN CHINA.

    Description of Event or Problem · 0

    THE PATIENT WAS DIAGNOSED AORTIC DISSECTION. WHEN THE SURGEON PUSHED THE INNER SHEATH FORWARD TO THE TEAR POSITION AT THE DESCENDING AORTA, THE PROXIMAL EDGE OF THE STENT RELEASED AUTOMATICALLY, SOMEHOW THE INNER SHEATH WAS PULLED APART FROM THE TIP, EVEN THE THIRD STAGE SAFE WAS STAYING ATTACHED. SO THAT THE STENT COULD ONLY BE RELEASED AT DESCENDING AORTA, AND THE TREATMENT WAS INEFFECTIVE. AND THE TIP WAS DROPPED OFF FROM THE STEEL WHEN THE SURGEON CHECKED IT AFTER WITHDREW ALL THE DELIVERY SYSTEM AFTER THE SURGERY. PATIENT OUTCOME - NO HARM.

    Additional Manufacturer Narrative · 1

    BOLTON MEDICAL IS VOLUNTARILY REPORTING A DEVICE MALFUNCTION RELATED TO THE RELAY NBS PLUSTHORACIC STENT-GRAFT SYSTEM. THE RELAY NBS PLUS DEVICE IS NOT MARKETED IN THE US, HOWEVER IT IS SIMILAR TO THE RELAY THORACIC STENT GRAFT WITH PLUS DELIVERY SYSTEM APPROVED FOR SALE IN THE US IN 2012 (P110038). THE RELAY NBS PLUS RELATED EVENT OCCURRED IN (B)(4).

    Description of Event or Problem · 1

    THE PATIENT WAS DIAGNOSED AORTIC DISSECTION. WHEN THE SURGEON PUSHED THE INNER SHEATH FORWARD TO THE TEAR POSITION AT THE DESCENDING AORTA, THE PROXIMAL EDGE OF THE STENT RELEASED AUTOMATICALLY, SOMEHOW THE INNER SHEATH WAS PULLED APART FROM THE TIP, EVEN THE THIRD STAGE SAFE WAS STAYING ATTACHED. SO THAT THE STENT COULD ONLY BE RELEASED AT DESCENDING AORTA, AND THE TREATMENT WAS INEFFECTIVE. AND THE TIP WAS DROPPED OFF FROM THE STEEL WHEN THE SURGEON CHECKED IT AFTER WITHDREW ALL THE DELIVERY SYSTEM AFTER THE SURGERY. PATIENT OUTCOME - NO HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490550 RELAY NBS THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM STENT, ENDOVASCULAR GRAFT, AORTIC MIH BOLTON MEDICAL, INC. B201022200

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR