BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELAY NBS PRO THORACIC STENT-GRAFT

    MDR report key: 12121206 · Received July 6, 2021

    Report

    Report Number
    2247858-2021-00057
    Event Type
    Injury
    Date Received
    July 6, 2021
    Date of Event
    June 7, 2021
    Report Date
    September 24, 2021
    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 AN EVENT RELATED TO A RELAY NBS PRO DEVICE. THE RELAY NBS PRO DEVICE WAS NOT MARKETED IN THE US PRIOR TO (B)(6) 2021, HOWEVER IT IS SIMILAR TO THE RELAY THORACIC STENT GRAFT WITH PLUS DELIVERY SYSTEM APPROVED FOR SALE IN THE US IN 2012 (P110038). THE EVENT OCCURRED IN THE US AND WAS PART OF CLINICAL TRIAL (B)(4), IDE#(B)(4), SITE NUMBER D02 NORTHWESTERN.

    Description of Event or Problem · 0

    SUBJECT HAD CONSIDERABLE DISEASE PROGRESSION RESULTING IN A TYPE 1A AND 1B ENDOLEAK. THE INVESTIGATOR DETERMINED AN EXPLANT OF THE RELAY NBS PRO DEVICE AND SURGICAL REVISION WERE THE BEST TREATMENT COURSE. PATIENT OUTCOME - UNKNOWN.

    Additional Manufacturer Narrative · 1

    BOLTON MEDICAL IS VOLUNTARILY REPORTING AN EVENT RELATED TO A RELAY NBS PRO DEVICE. THE RELAY NBS PRO 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 EVENT OCCURRED IN THE US AND WAS PART OF CLINICAL TRIAL (B)(6), (B)(4).

    Description of Event or Problem · 1

    SUBJECT HAD CONSIDERABLE DISEASE PROGRESSION RESULTING IN A TYPE 1A AND 1B ENDOLEAK. THE INVESTIGATOR DETERMINED AN EXPLANT OF THE RELAY NBS PRO DEVICE AND SURGICAL REVISION WERE THE BEST TREATMENT COURSE. PATIENT OUTCOME - UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1021191 RELAY NBS PRO THORACIC STENT-GRAFT STENT, ENDOVASCULAR GRAFT, AORTIC MIH BOLTON MEDICAL, INC. 181109200

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other