BEUDAMED
    FDA Adverse Event Death Summary report: N

    RELAY PRO NBS THORACIC STENT-GRAFT SYSTEM

    MDR report key: 21935239 · Received April 30, 2025

    Report

    Report Number
    2247858-2025-00122
    Event Type
    Death
    Date Received
    April 30, 2025
    Date of Event
    April 16, 2025
    Report Date
    April 30, 2025
    Manufacturer
    BOLTON MEDICAL, INC.
    Product Code
    MIH
    UDI-DI
    00843576150959
    PMA / PMN Number
    P200045
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT WAS INVOLVED WITH TWO DEVICES. DEVICE 1 IS BEING REPORTED UNDER MDR 2247858-2025-00121. BOLTON MEDICAL, INC. (D/B/A TERUMO AORTIC), HEREIN KNOWN AS THE "COMPANY", IS SUBMITTING THIS REPORT PURSUANT TO 21 CFR PART 803, HAS MADE REASONABLE EFFORTS TO OBTAIN COMPLETE INFORMATION, AND HAS PROVIDED AS MUCH AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT IS BASED ON INFORMATION OBTAINED BY THE COMPANY, WHICH MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE REGULATIONS. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN, UNAVAILABLE, OR NOT APPLICABLE. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY ANYONE THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE A LEGAL ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY DEFECTS OR HAS MALFUNCTIONED, AS DEFINED FROM A LEGAL STANDPOINT. THESE WORDS ARE INCLUDED IN THE REPORT AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE CERTAIN REGULATIONS, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Description of Event or Problem · 0

    "DEATH: ON (B)(6), AN EMERGENCY TEVAR WAS PERFORMED FOR AN AORTIC DISSECTION. THE RELAY PRO STENT GRAFT CONCERNED (28-N4-32-209-28U, LOT#: 2404170130) WAS IMPLANTED CENTRALLY AND A RELAY PRO STENT GRAFT (28-N4-32-164-28U, LOT#: 2407130037) WAS ADDITIONALLY IMPLANTED PERIPHERALLY. THE PROCEDURE WAS COMPLETED WITHOUT ANY PROBLEMS WITH THE PROCEDURE OR THE DEVICES THEMSELVES. ON (B)(6), THE PATIENT'S CONDITION SUDDENLY CHANGED, AND THE PATIENT DIED. AFTER DEATH, A CT SCAN REVEALED THAT THE INTERNAL PRESSURE IN THE FALSE LUMEN HAD INCREASED DUE TO THE EXPANSION OF THE TRUE LUMEN CAUSED BY THE IMPLANTATION OF THE STENT GRAFTS, AND THE FALSE LUMEN HAD RUPTURED AROUND THE ABDOMEN. PHYSICIAN'S COMMENT: THE PHYSICIAN DID THE BEST THAT HE COULD WITH THE MEANS AVAILABLE TO THE HOSPITAL. THERE WAS NO OTHER CHOICE. PHYSICIAN'S COMMENT ON CAUSAL RELATIONSHIP: THE MEANS TAKEN FOR THE AORTIC DISSECTION WERE THE BEST, GIVEN THE EMERGENCY TREATMENT ON APRIL 14, BUT THE TRUE LUMEN EXPANDED MORE THAN EXPECTED. OPERATION TYPE: EMERGENCY TEVAR FOR AN AORTIC DISSECTION, NO BLOOD LOSS, ANCILLARY DEVICE USED: 28-N4-32-164-28U (LOT#: 2407130037), NO IMAGE AVAILABLE DUE TO HOSPITAL POLICY, NO PRE-CASE PLAN AVAILABLE DUE TO HOSPITAL POLICY, NO ADDITIONAL INFORMATION AVAILABLE DUE TO HOSPITAL POLICY, (TC#: (B)(4))." PATIENT OUTCOME: "THE PATIENT DIED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1241274 RELAY PRO NBS THORACIC STENT-GRAFT SYSTEM STENT, ENDOVASCULAR GRAFT, AORTIC MIH BOLTON MEDICAL, INC. 2407130037 00843576150959

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death| O