BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM

    MDR report key: 10259761 · Received July 10, 2020

    Report

    Report Number
    2247858-2020-00034
    Event Type
    Malfunction
    Date Received
    July 10, 2020
    Date of Event
    March 3, 2020
    Report Date
    July 31, 2020
    Manufacturer
    BOLTON MEDICAL, INC.
    Product Code
    MIH
    PMA / PMN Number
    P110038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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 UK.

    Description of Event or Problem · 0

    "TYPE III ENDOLEAK NOTED AT FOLLOW UP VISIT (B)(6) 2020, TEVAR PROCEDURE ON (B)(6) 2020 AWAITING FURTHER INFORMATION FROM SITE." PATIENT OUTCOME: "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 (B)(6).

    Description of Event or Problem · 1

    "TYPE III ENDOLEAK NOTED AT FOLLOW UP VISIT (B)(6) 2020, TEVAR PROCEDURE ON (B)(6) 2020 AWAITING FURTHER INFORMATION FROM SITE." PATIENT OUTCOME: "ONGOING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720191 RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM STENT, ENDOVASCUALR GRAFT, AORTIC MIH BOLTON MEDICAL, INC. B190090100

    Patients

    Seq Age Sex Outcome Treatment
    1 00 YR Other| R