BEUDAMED
    FDA Adverse Event Death Summary report: N

    CUSTOM-MADE TREO ABDOMINAL STENT-GRAFT SYSTEM

    MDR report key: 21054792 · Received January 2, 2025

    Report

    Report Number
    2247858-2025-00003
    Event Type
    Death
    Date Received
    January 2, 2025
    Date of Event
    December 9, 2024
    Report Date
    April 1, 2025
    Manufacturer
    BOLTON MEDICAL, INC.
    Product Code
    MIH
    PMA / PMN Number
    P190015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 GERMANY. 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

    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 GERMANY. 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

    "DURING THE RELEASE OF THE MAIN BODY THE CONSTRICTION WIRE WAS TORN INSIDE THE DELIVERY SYSTEM APPROX. 10 CM TO THE DISTAL END OF THE SYSTEM. THE DELIVERY SYSTEM HAD TO BE DISMANTLED TO REACH THE REST OF THE WIRE TO BE ABLE TO RELEASE THE BODY. AFTER SEVERAL ATTEMPTS THE WIRE COULD BE PULLED BACK. THE CONE TIP COULD ALSO NOT BE RETRACTED. FINALLY, THE GRAFT WAS NOT IN AN OPTIMAL POSITION BUT THE PHYSICIAN MANAGED TO CANNULATE ALL TARGET VESSELS AND PLACED THE BRIDGING STENTS. FINAL ANGIOGRAM SHOWED A SATISFYING RESULT. THE WHOLE PROCEDURE TOOK ABOUT 7 HOURS." PATIENT OUTCOME: "PATIENT CONDITION IS STABLE. ADDITIONAL INFORMATION RECEIVED ON 12/16/2024: PATIENT PASSED AWAY ON POD 2."

    Description of Event or Problem · 0

    "DURING THE RELEASE OF THE MAIN BODY THE CONSTRICTION WIRE WAS TORN INSIDE THE DELIVERY SYSTEM APPROX. 10CM TO THE DISTAL END OF THE SYSTEM. THE DELIVERY SYSTEM HAD TO BE DISMANTLED TO REACH THE REST OF THE WIRE TO BE ABLE TO RELEASE THE BODY. AFTER SEVERAL ATTEMPTS THE WIRE COULD BE PULLED BACK. THE CONE TIP COULD ALSO NOT BE RETRACTED. FINALLY, THE GRAFT WAS NOT IN AN OPTIMAL POSITION BUT THE PHYSICIAN MANAGED TO CANNULATE ALL TARGET VESSELS AND PLACED THE BRIDGING STENTS. FINAL ANGIOGRAM SHOWED A SATISFYING RESULT. THE WHOLE PROCEDURE TOOK ABOUT 7 HOURS." PATIENT OUTCOME: "PATIENT CONDITION IS STABLE. ADDITIONAL INFORMATION RECEIVED ON 12/16/2024: PATIENT PASSED AWAY ON POD 2."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1536502 CUSTOM-MADE TREO ABDOMINAL STENT-GRAFT SYSTEM STENT, ENDOVASCULAR GRAFT, AORTIC MIH BOLTON MEDICAL, INC. 2410160425

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Death