BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM

    MDR report key: 11386483 · Received February 26, 2021

    Report

    Report Number
    2247858-2021-00019
    Event Type
    Malfunction
    Date Received
    February 26, 2021
    Date of Event
    February 1, 2021
    Report Date
    September 2, 2021
    Manufacturer
    BOLTON MEDICAL, INC.
    Product Code
    MIH
    PMA / PMN Number
    P110038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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 SPAIN.

    Description of Event or Problem · 0

    THE SHEATH OF THE DEVICE GOT LOOSE FROM THE MAIN DEVICE. THIS OCCURRED WHEN IT WAS INSIDE THE BODY OF THE PATIENT, SO THE BLOOD CAME OUT THROUGH THE SHEATH. DR. (B)(6) TOOK EVERYTHING BACK AND TRIED TO STICK THE SHEATH INSIDE THE MAIN SYSTEM. THEY CONTROLLED THE HAEMORRHAGE AT LEAST TO FINISH THE PROCEDURE. ONCE ALL FINISHED, OUTSIDE THE PATIENT, WE CLEARLY SAW HOW THE SHEATH IS COMPLETELY TAKEN OFF FROM THE MAIN SYSTEM. PATIENT OUTCOME: "NO ADVERSE EVENTS OCCURRED. NO OTHER CONSEQUENCES."

    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

    THE SHEATH OF THE DEVICE GOT LOOSE FROM THE MAIN DEVICE. THIS OCCURRED WHEN IT WAS INSIDE THE BODY OF THE PATIENT, SO THE BLOOD CAME OUT THROUGH THE SHEATH. DR. (B)(6) TOOK EVERYTHING BACK AND TRIED TO STICK THE SHEATH INSIDE THE MAIN SYSTEM. THEY CONTROLLED THE HAEMORRHAGE AT LEAST TO FINISH THE PROCEDURE. ONCE ALL FINISHED, OUTSIDE THE PATIENT, WE CLEARLY SAW HOW THE SHEATH IS COMPLETELY TAKEN OFF FROM THE MAIN SYSTEM. PATIENT OUTCOME: "NO ADVERSE EVENTS OCCURRED. NO OTHER CONSEQUENCES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285832 RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM STENT, ENDOVASCULAR GRAFT, AORTIC MIH BOLTON MEDICAL, INC. 2012140268

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR