BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELAY THORACIC STENT-GRAFT SYSTEM WITH PLUS DELIVERY SYSTEM

    MDR report key: 15651022 · Received October 21, 2022

    Report

    Report Number
    2247858-2022-00161
    Event Type
    Malfunction
    Date Received
    October 21, 2022
    Date of Event
    September 24, 2022
    Report Date
    March 31, 2022
    Manufacturer
    BOLTON MEDICAL, INC.
    Product Code
    MIH
    PMA / PMN Number
    P110038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    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 THAILAND.

    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 THAILAND.

    Description of Event or Problem · 0

    RELAY NBS PLUS THORACIC STENT GRAFT (28-N2-34-154-30-90S) LOT: B220610110. ; PLANNED IMPLANT AT ZONE 2 COVER LSA. DURING WITHDRAW THE ENTIRE SYSTEM FROM THE PATIENT. THE TIP WAS DISCONNECTED FROM THE DELIVERY SYSTEM INSIDE PATIENT'S VESSEL AT LEFT COMMON FEMORAL ARTERY. PATIENT OUTCOME - "THE LCFA WAS REPAIRED."

    Description of Event or Problem · 0

    RELAY NBS PLUS THORACIC STENT GRAFT (28-N2-34-154-30-90S) LOT: B220610110; PLANNED IMPLANT AT ZONE 2 COVER LSA. DURING WITHDRAW THE ENTIRE SYSTEM FROM THE PATIENT. THE TIP WAS DISCONNECTED FROM THE DELIVERY SYSTEM INSIDE PATIENT'S VESSEL AT LEFT COMMON FEMORAL ARTERY AS THE PICTURE IN ATTACHED. PATIENT OUTCOME: "THE LCFA WAS REPAIRED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1928929 RELAY THORACIC STENT-GRAFT SYSTEM WITH PLUS DELIVERY SYSTEM STENT, ENDOVASCULAR GRAFT, AORTIC MIH BOLTON MEDICAL, INC. B220610110

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male