BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELAY NBS THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM

    MDR report key: 12175938 · Received July 15, 2021

    Report

    Report Number
    2247858-2021-00063
    Event Type
    Malfunction
    Date Received
    July 15, 2021
    Date of Event
    June 18, 2021
    Report Date
    August 19, 2021
    Manufacturer
    BOLTON MEDICAL, INC.
    Product Code
    MIH
    PMA / PMN Number
    P110038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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 INDIA.

    Description of Event or Problem · 0

    THERE WAS A TYPE B DISSECTION CASE IN MEDANTA HOSPITAL GURUGRAM. DURING THE CASE OUR DEVICE GOT STUCK AND SURGERY COULD NOT BE COMPLETED. DURING THE ADVANCEMENT OF THE SECONDARY SHEATH, HALF CAME OUT AND THEN GOT STUCK. OPERATOR TRIED TO PUSH THE GRAY HANDLE AND THAT GOT STUCK DEVICE WAS REMOVED, PATIENT WAS REFERRED FOR SURGICAL REPAIR. PATIENT OUTCOME - "PLEASE NOTE THERE WAS NOT A DEATH OR PATIENT COMPLICATIONS DURING THIS PROCEDURE. PATIENT IS DOING FINE."

    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)(6).

    Description of Event or Problem · 1

    THERE WAS A TYPE B DISSECTION CASE IN (B)(6). DURING THE CASE OUR DEVICE GOT STUCK AND SURGERY COULD NOT BE COMPLETED. DURING THE ADVANCEMENT OF THE SECONDARY SHEATH, HALF CAME OUT AND THEN GOT STUCK. OPERATOR TRIED TO PUSH THE GRAY HANDLE AND THAT GOT STUCK DEVICE WAS REMOVED, PATIENT WAS REFERRED FOR SURGICAL REPAIR. PATIENT OUTCOME - "PLEASE NOTE THERE WAS NOT A DEATH OR PATIENT COMPLICATIONS DURING THIS PROCEDURE. PATIENT IS DOING FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1075808 RELAY NBS THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM STENT, ENDOVASCULAR GRAFT, AORTIC MIH BOLTON MEDICAL, INC. B190429109

    Patients

    Seq Age Sex Outcome Treatment
    1 00 YR Required Intervention