BEUDAMED
    FDA Adverse Event Death Summary report: N

    RELAY THORACIC STENT-GRAFT/PLUS DELIVERY SYST

    MDR report key: 4920739 · Received July 15, 2015

    Report

    Report Number
    2247858-2015-00014
    Event Type
    Death
    Date Received
    July 15, 2015
    Date of Event
    June 17, 2015
    Report Date
    July 15, 2015
    Manufacturer
    BOLTON MEDICAL, INC.
    Product Code
    MIH
    PMA / PMN Number
    P110038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DELIVERY SYSTEM WAS NOT RETURNED FOR INVESTIGATION. PER THE NARRATIVE INFO BOLTON MEDICAL OF THE INCIDENT, THIS UNIT WAS IMPLANTED ON (B)(6) 2013 AND DURING THE PROCEDURE TYPE 1A ENDOLEAK WAS CONFIRMED. THE DEGREE OF THE ENDOLEAK AND TREATMENT FOR THE ENDOLEAK IS UNK. SINCE NO IMAGES/VIDEOS OF THE CASE ARE AVAILABLE, NO ADDITIONAL INVESTIGATION CAN BE PERFORMED TO DETERMINE IF ADDITIONAL STEPS DURING THE PROCEDURE COULD HAVE MINIMIZED THE EFFECT OF THE FAILURE EXPERIENCED. THERE WAS NO AUTOPSY PERFORMED TO CONFIRM IF THE CAUSE OF THE DEATH WAS DUE TO RUPTURE SECONDARY TO UNTREATED TYPE 1A ENDOLEAK.

    Description of Event or Problem · 1

    CASE REPORT FROM JAPAN REPORTED AS: "(B)(6) 2015 - JLL SALES REPRESENTATIVE RECEIVED THE INFO ABOUT RELAY PLUS IMPLANTED PT'S DEATH (THE DEATH DATE WAS (B)(6) 2015). RELAY PLUS HAD BEEN IMPLANTED ON (B)(6) 2013 AT THE DIFFERENT HOSPITAL. DURING THIS IMPLANT, TYPE 1A ENDLEAK WAS CONFIRMED. THE DEGREE ENDLEAK AND TREATMENT FOR ENDLEAK WERE UNK. ACCORDING TO THE PHYSICIAN, THE CAUSE OF DEATH WAS ANEURYSM RUPTURE, AND IT COULD BE RELATED TO TYPE 1A ENDLEAK OBSERVED DURING THE IMPLANTATION. IT IS UNK IF THE AUTOPSY IS PERFORMED OR NOT". OUTCOME OF THE PT: "THE PT DEATH WAS ON (B)(6) 2015. THE CAUSE OF DEATH WAS ANEURYSM RUPTURE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460876 RELAY THORACIC STENT-GRAFT/PLUS DELIVERY SYST STENT, ENDOVASCULAR GRAFT, AORTIC MIH BOLTON MEDICAL, INC. 130418073

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death