BEUDAMED
    FDA Adverse Event Death Summary report: N

    RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM

    MDR report key: 13859660 · Received March 23, 2022

    Report

    Report Number
    2247858-2022-00052
    Event Type
    Death
    Date Received
    March 23, 2022
    Date of Event
    December 7, 2021
    Report Date
    July 7, 2022
    Manufacturer
    BOLTON MEDICAL, INC.
    Product Code
    MIH
    PMA / PMN Number
    P110038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BOLTON MEDICAL IS VOLUNTARILY REPORTING AN ADVERSE EVENT RELATED TO THE RELAY NBS THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM. THE RELAY NBS PLUS DEVICE IS NOT MARKETED IN THE US; HOWEVER IT IS SIMILAR TO THE RELAY PLUS THORACIC STENT GRAFT WITH PLUS DELIVERY SYSTEM APPROVED FOR SALE IN THE US (P110038). THE RELAY NBS PLUS RELATED EVENT OCCURRED IN THE UK.

    Description of Event or Problem · 0

    "FOR PATIENT (B)(4) AN ENDOLEAK TYPE IB OCCURRED AFTER THE PROCEDURE ON (B)(6) 2021, AT THE DISTAL THORACIC AORTA . ANTICOAG, ANTIPLATELET OR ANTIBIOTIC TREATMENT WAS ADMINISTERED DURING THE PROCEDURE. NO DEVICE DEFICIENCIES OCCURRED. THE EVENT WAS REPORTED AS RELATED TO THE PROCEDURE AND DEVICE (RELATED TO LEG EXTENSION). NO ACTION WAS USED TO TREAT THE EVENT. THIS PATIENT DIED ON (B)(6) 2021 THE EVENT WAS REPORTED AS UNDETERMINED WHETHER THE EVENT WAS RELATED TO THE PROCEDURE, DEVICE OR EXISTING MEDICAL CONDITION. NO ACTIONS WERE USED TO PREVENT / TREAT EVENT AND NO AUTOPSY PERFORMED." PATIENT OUTCOME: "PATIENT DIED."

    Description of Event or Problem · 0

    "FOR PATIENT (B)(6) AN ENDOLEAK TYPE IB OCCURRED AFTER THE PROCEDURE ON (B)(6) 2021, AT THE DISTAL THORACIC AORTA. ANTICOAG, ANTIPLATELET OR ANTIBIOTIC TREATMENT WAS ADMINISTERED DURING THE PROCEDURE. NO DEVICE DEFICIENCIES OCCURRED. THE EVENT WAS REPORTED AS RELATED TO THE PROCEDURE AND DEVICE (RELATED TO LEG EXTENSION). NO ACTION WAS USED TO TREAT THE EVENT. THIS PATIENT DIED ON (B)(6) 2021 THE EVENT WAS REPORTED AS UNDETERMINED WHETHER THE EVENT WAS RELATED TO THE PROCEDURE, DEVICE OR EXISTING MEDICAL CONDITION. NO ACTIONS WERE USED TO PREVENT / TREAT EVENT AND NO AUTOPSY PERFORMED." PATIENT OUTCOME - "PATIENT DIED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543825 RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM STENT, ENDOVASCULAR GRAFT, AORTIC MIH BOLTON MEDICAL, INC. B190710109

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Death