BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM

    MDR report key: 8564770 · Received April 30, 2019

    Report

    Report Number
    2247858-2019-00025
    Event Type
    Malfunction
    Date Received
    April 30, 2019
    Date of Event
    March 21, 2019
    Report Date
    July 31, 2019
    Manufacturer
    BOLTON MEDICAL, INC.
    Product Code
    MIH
    PMA / PMN Number
    P110038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BOLTON MEDICAL IS VOLUNTARILY REPORTING A DEVICE MALFUNCTION RELATED TO THE RELAY NBS PLUS STENT-GRAFT SYSTEM. THE RELAY NBS PLUS STENT-GRAFT SYSTEM 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 STENT-GRAFT SYSTEM RELATED EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    BOLTON MEDICAL IS VOLUNTARILY REPORTING A DEVICE MALFUNCTION RELATED TO THE RELAY NBS PLUS STENT-GRAFT SYSTEM. THE RELAY NBS PLUS STENT-GRAFT SYSTEM 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 STENT-GRAFT SYSTEM RELATED EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    "AFTER UNPACKING THE DEVICE, THE PHYSICIAN NOTICED THAT THE WHITE TIP RELEASE HOLDER (PART NUMBER 13 IN THE IFU) WAS MISSING. THEREFORE, THE PHYSICIAN DECIDED NOT TO USE THE DEVICE AND TOOK ANOTHER ONE INSTEAD."

    Description of Event or Problem · 1

    "AFTER UNPACKING THE DEVICE, THE PHYSICIAN NOTICED THAT THE WHITE TIP RELEASE HOLDER (PART NUMBER 13 IN THE IFU) WAS MISSING. THEREFORE, THE PHYSICIAN DECIDED NOT TO USE THE DEVICE AND TOOK ANOTHER ONE INSTEAD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358679 RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM STENT, ENDOVASCUALR GRAFT, AORTIC MIH BOLTON MEDICAL, INC. B170914155

    Patients

    Seq Age Sex Outcome Treatment
    1 00 YR