BEUDAMED
    FDA Adverse Event Death Summary report: N

    CUSTOM-MADE TREO ABDOMINAL STENT-GRAFT SYSTEM

    MDR report key: 21286765 · Received January 31, 2025

    Report

    Report Number
    2247858-2025-00039
    Event Type
    Death
    Date Received
    January 31, 2025
    Date of Event
    December 13, 2024
    Report Date
    June 27, 2025
    Manufacturer
    BOLTON MEDICAL, INC.
    Product Code
    MIH
    PMA / PMN Number
    P190015
    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 EVENT RELATED TO A TREO CUSTOM-MADE DEVICE. THE CUSTOM MADE TREO DEVICES ARE NOT MARKETED IN THE US, HOWEVER THEY ARE SIMILAR TO THE TREO ABDOMINAL STENT GRAFT DELIVERY SYSTEM APPROVED FOR SALE IN THE US (P190015). THE EVENT OCCURRED IN UNITED KINGDOM. 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.

    Additional Manufacturer Narrative · 0

    THE PATIENT DEATH WAS REPORTED TO (B)(6) ON 12/17/2024 WITH NO ADDITIONAL INFORMATION. EMAILS WERE SENT TO THE CASE REP ON 12/17/2024, 12/19/2024, 12/20/2024, 12/26/2024, 01/06/2025, AND 01/10/2025 TO TRY TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PATIENT DEATH. AN EMAIL FROM THE CASE REP DATED 01/10/2025 STATED THAT THE SURGEON IS UNABLE TO PROVIDE ANY DETAILS UNTIL HE RECEIVES GUIDANCE FROM THE LEGAL DEPARTMENT AT HIS TRUST. ON 01/28/2025, PERMISSION WAS GIVEN FROM THE HEAD OF PRIVACY AND TRUST LEGAL DEPARTMENT TO SEND THE EVENT DETAILS. THEREFORE, THIS REPORT IS SUBMITTED AFTER THE 30-DAY TIME-FRAME. BOLTON MEDICAL IS VOLUNTARILY REPORTING AN EVENT RELATED TO A TREO CUSTOM-MADE DEVICE. THE CUSTOM-MADE TREO DEVICES ARE NOT MARKETED IN THE US; HOWEVER, THEY ARE SIMILAR TO THE TREO ABDOMINAL STENT GRAFT DELIVERY SYSTEM APPROVED FOR SALE IN THE US (P190015). THE EVENT OCCURRED IN THE UNITED KINGDOM. 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

    "PAT 5111-B1 + PAT 5209-L1 (28-LC15W10012S1949, LOT # 2408190329) THE PATIENT WOKE UP FROM THE PROCEDURE, AND LATER HE THEN DROPPED HIS BP, WHICH, UNFORTUNATELY, DIDN'T RECOVER. ADDITIONAL INFORMATION RECEIVED FROM THE SITE ON 01/28/2025: "THIS PATIENT UNDERWENT A FENESTRATED ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM REPAIR ON (B)(6) 2024. THE PROCEDURE WAS MORE COMPLICATED THAN USUAL DUE TO DIFFICULTY IN ACHIEVING STABLE CANNULATION OF THE VISCERAL VESSELS. THIS ADDED TO THE DURATION OF THE PROCEDURE. BLOOD LOSS THROUGH THE DELIVERY SYSTEM OF THE ENDOVASCULAR GRAFT WHILST SLOW, WAS CUMULATIVELY SIGNIFICANT AT AROUND 1500ML. THE ANEURYSM REPAIR WAS HOWEVER COMPLETED SATISFACTORILY. THE IMMEDIATE POST-OPERATIVE RECOVERY OF THE PATIENT WAS UNEVENTFUL BUT SEVERAL HOURS AFTER THE PROCEDURE THEY BECAME UNWELL AND, WHILST UNCONFIRMED, THE CLINICAL ASSESSMENT WAS THAT THIS WAS THE RESULT OF AN ACUTE CORONARY EVENT. THEY SUBSEQUENTLY DEVELOPED SIGNS AND SYMPTOMS OF SPINAL CORD ISCHAEMIA AND BECAME INCREASINGLY UNWELL. THE PATIENT DIED APPROXIMATELY 24 HOURS AFTER THE ANEURYSM REPAIR. FOLLOWING DISCUSSION WITH THE UNIVERSITY HOSPITALS OF LEICESTER NHS TRUST MEDICAL EXAMINER THE DEATH WAS REPORTED TO HM CORONER WHO HAS OPENED AN INQUEST, WHICH IS AWAITED." PATIENT OUTCOME: "PATIENT DEATH."

    Description of Event or Problem · 0

    (B)(6). THE PATIENT WOKE UP FROM THE PROCEDURE, AND LATER HE THEN DROPPED HIS BP, WHICH, UNFORTUNATELY, DIDN'T RECOVER. ADDITIONAL INFORMATION RECEIVED FROM THE SITE ON 01/28/2025: THIS PATIENT UNDERWENT A FENESTRATED ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM REPAIR ON (B)(6) 2024. THE PROCEDURE WAS MORE COMPLICATED THAN USUAL DUE TO DIFFICULTY IN ACHIEVING STABLE CANNULATION OF THE VISCERAL VESSELS. THIS ADDED TO THE DURATION OF THE PROCEDURE. BLOOD LOSS THROUGH THE DELIVERY SYSTEM OF THE ENDOVASCULAR GRAFT WHILST SLOW, WAS CUMULATIVELY SIGNIFICANT AT AROUND 1500ML. THE ANEURYSM REPAIR WAS HOWEVER COMPLETED SATISFACTORILY. THE IMMEDIATE POST-OPERATIVE RECOVERY OF THE PATIENT WAS UNEVENTFUL BUT SEVERAL HOURS AFTER THE PROCEDURE THEY BECAME UNWELL AND, WHILST UNCONFIRMED, THE CLINICAL ASSESSMENT WAS THAT THIS WAS THE RESULT OF AN ACUTE CORONARY EVENT. THEY SUBSEQUENTLY DEVELOPED SIGNS AND SYMPTOMS OF SPINAL CORD ISCHAEMIA AND BECAME INCREASINGLY UNWELL. THE PATIENT DIED APPROXIMATELY 24 HOURS AFTER THE ANEURYSM REPAIR. FOLLOWING DISCUSSION WITH THE HOSPITAL'S (B)(6) MEDICAL EXAMINER, THE DEATH WAS REPORTED TO (B)(6) CORONER WHO HAS OPENED AN INQUEST, WHICH IS AWAITED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474543 CUSTOM-MADE TREO ABDOMINAL STENT-GRAFT SYSTEM STENT, ENDOVASCULAR GRAFT, AORTIC MIH BOLTON MEDICAL, INC. 2408150245

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other| D