BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM

    MDR report key: 11321146 · Received February 12, 2021

    Report

    Report Number
    2247858-2021-00012
    Event Type
    Injury
    Date Received
    February 12, 2021
    Date of Event
    June 19, 2020
    Report Date
    April 23, 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 THE RELAYNBS PLUS THORACIC STENT-GRAFT SYSTEM. THE RELAYNBS 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 RELAYNBS PLUS RELATED EVENT OCCURRED IN THE NETHERLANDS.

    Description of Event or Problem · 0

    SPINAL CORD ISCHEMIA. IT IS NOT DETERMINED IF THE EVENT IS RELATED TO THE DEVICE. PATIENT OUTCOME: "EVENT IS ONGOING."

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    SPINAL CORD ISCHEMIA. IT IS NOT DETERMINED IF THE EVENT IS RELATED TO THE DEVICE. PATIENT OUTCOME: "EVENT IS ONGOING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218578 RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM STENT, ENDOVASCULAR GRAFT, AORTIC MIH BOLTON MEDICAL, INC. 2003250081

    Patients

    Seq Age Sex Outcome Treatment
    1 00 YR Other