BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM-MADE TREO ABDOMINAL STENT-GRAFT SYSTEM

    MDR report key: 21291961 · Received February 3, 2025

    Report

    Report Number
    2247858-2025-00020
    Event Type
    Malfunction
    Date Received
    February 3, 2025
    Date of Event
    January 8, 2025
    Report Date
    April 8, 2025
    Manufacturer
    BOLTON MEDICAL, INC
    Product Code
    MIH
    PMA / PMN Number
    P190015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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. 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 ITALY.

    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 ITALY. 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

    "AFTER MAIN BODY DEPLOYMENT (CORRECT POSITIONING HAD ALREADY BEEN CONFIRMED THOUGH ANGIOGRAPHY) THE PHYSICIAN PROCEEDED TO RELEASE PROXIMAL CLASPING. HE CORRECTLY PUSHED FORWARD THE GRAY LOCK AND ROTATED IT TO DISENGAGE THE SECURE MECHANISM. THEN HE PULLED BACK THE BLACK RELEASE GRIP BUT THIS MOVEMENT DID NOT RESULT IN BARE STENT RELEASING. HE TRIED TO PULL BACK THE RELEASE GRIP AS MUCH AS POSSIBLE, BUT NOTHING CHANGED. IT WAS ENOUGH TO USE A SMALL CLAMP AND PULL THE GREEN TUBE (WITHOUT EVEN OPEN THE HYPO TUBE) TO RELEASE THE PROXIMAL BARE STENT. WITH THIS MANOUVER, THE GREEN TUBE WAS PULLED BACK JUST A MILLIMETER OR SO BUT IT WAS ENOUGH TO ALLOW THE RELEASE OF PROXIMAL BARE STENT WITHOUT COMPROMISING THE CORRECT POSITIONING OF THE GRAFT AND WITHOUT CAUSING ANY HARM TO THE PATIENT. FINAL ANGIOGRAPHY CONFIRMED THE GOOD RESULT." PATIENT OUTCOME: "PATIENT DID NOT SUFFER ANY CONSEQUENCE."

    Description of Event or Problem · 0

    "AFTER MAIN BODY DEPLOYMENT (CORRECT POSITIONING HAD ALREADY BEEN CONFIRMED THOUGH ANGIOGRAPHY) THE PHYSICIAN PROCEEDED TO RELEASE PROXIMAL CLASPING. HE CORRECTLY PUSHED FORWARD THE GRAY LOCK AND ROTATED IT TO DISENGAGE THE SECURE MECHANISM. THEN HE PULLED BACK THE BLACK RELEASE GRIP BUT THIS MOVEMENT DID NOT RESULT IN BARE STENT RELEASING. HE TRIED TO PULL BACK THE RELEASE GRIP AS MUCH AS POSSIBLE, BUT NOTHING CHANGED. IT WAS ENOUGH TO USE A SMALL CLAMP AND PULL THE GREEN TUBE (WITHOUT EVEN OPEN THE HYPO TUBE) TO RELEASE THE PROXIMAL BARE STENT. WITH THIS MANEUVER, THE GREEN TUBE WAS PULLED BACK JUST A MILLIMETER OR SO BUT IT WAS ENOUGH TO ALLOW THE RELEASE OF PROXIMAL BARE STENT WITHOUT COMPROMISING THE CORRECT POSITIONING OF THE GRAFT AND WITHOUT CAUSING ANY HARM TO THE PATIENT. FINAL ANGIOGRAPHY CONFIRMED THE GOOD RESULT." PATIENT OUTCOME: "PATIENT DID NOT SUFFER ANY CONSEQUENCE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1294807 CUSTOM-MADE TREO ABDOMINAL STENT-GRAFT SYSTEM STENT, ENDOVASCULAR GRAFT, AORTIC MIH BOLTON MEDICAL, INC 2410100189

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male