BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELAY PLUS THORACIC STENT-GRAFT

    MDR report key: 11453976 · Received March 10, 2021

    Report

    Report Number
    2247858-2021-00025
    Event Type
    Injury
    Date Received
    March 10, 2021
    Date of Event
    January 5, 2021
    Report Date
    July 27, 2021
    Manufacturer
    BOLTON MEDICAL, INC.
    Product Code
    MIH
    PMA / PMN Number
    P110038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    ENDOLEAK TYPE 1A (FENESTRATION) IDENTIFIED. VOCAL FOLD PARALYSIS (HOARSENESS) SINCE PROCEDURE. PATIENT OUTCOME - "ONGOING".

    Additional Manufacturer Narrative · 1

    BOLTON MEDICAL IS VOLUNTARILY REPORTING A DEVICE MALFUNCTION RELATED TO A RELAY NBS PLUS CUSTOM-MADE DEVICE. THE RELAY NBS PLUS CUSTOM-MADE 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 ((B)(4)). THE RELAY NBS PLUS CUSTOM-MADE DEVICE RELATED EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    ENDOLEAK TYPE 1A (FENESTRATION) IDENTIFIED. VOCAL FOLD PARALYSIS (HOARSENESS) SINCE PROCEDURE. PATIENT OUTCOME - "ONGOING".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349717 RELAY PLUS THORACIC STENT-GRAFT STENT, ENDOVASCULAR GRAFT, AORTIC MIH BOLTON MEDICAL, INC. 1912170277

    Patients

    Seq Age Sex Outcome Treatment
    1 00 YR Other