BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREO ABDOMINAL STENT-GRAFT SYSTEM

    MDR report key: 18416085 · Received December 28, 2023

    Report

    Report Number
    2247858-2023-00331
    Event Type
    Malfunction
    Date Received
    December 28, 2023
    Date of Event
    November 28, 2023
    Report Date
    March 1, 2024
    Manufacturer
    BOLTON MEDICAL, INC.
    Product Code
    MIH
    PMA / PMN Number
    P190015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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.

    Additional Manufacturer Narrative · 0

    THIS MDR WAS INADVERTENTLY SUBMITTED. THIS FOLLOW-UP TO MDR-2247858-2023-00331 IS BEING SUBMITTED TO CLARIFY THAT THE COMPLAINT, (B)(4), WAS DEEMED NOT REPORTABLE SINCE THE MANUFACTURING INCONSISTENCY WAS DETECTED BEFORE CASE START AND HAD NO EFFECT ON THE PATIENT. 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

    "UPON FLUOROSCOPIC EXAMINATION OF DEVICE BEFORE ENTERING THE PATIENT IT WAS DETERMINED THAT THE DEVICE WAS LOADED UPSIDE DOWN WITH THE CONTRA LIMB LOADED IN THE POSTERIOR POSITION VS ANTERIOR. WHEN PHYSICIAN ROTATED THE SYSTEM TO THE PATIENT'S LEFT THE CONTRA LIMB MAX AND MIN FLOURO MARKERS MOVED TO THE PATIENT RIGHT VS LEFT. THE PHYSICIAN REMEDIED THE SITUATION BY ROTATING THE DEVICE TO THE PATIENTS RIGHT TO ORIENT THE CONTRA LIMB TO THE PATIENTS LEFT AS DESIRED. PHYSICIAN WAS RELYING ON THE MB FLUSH VALVE TO GAUGE ORIENTATION. FURTHER CONVERSATIONS NEED TO BE HAD WITH THE CUSTOMER TO REVIEW HOW WE LOAD OUR GRAFTS INTO THE DELIVERY SYSTEM AND TECHNIQUES FOR CONTRA GATE ORIENTATION. CUSTOMER MENTIONED THAT THIS WOULD BE UNACCEPTABLE ON ANY FUTURE FENESTRATED TECHNOLOGY THAT WE WOULD LAUNCH." PATIENT OUTCOME - "NO CLINICAL SEQUELAE AS THE GRAFT WAS SAFELY DEPLOYED WITH THE DESIRED GATE ORIENTATION."

    Description of Event or Problem · 0

    "UPON FLUOROSCOPIC EXAMINATION OF DEVICE BEFORE ENTERING THE PATIENT IT WAS DETERMINED THAT THE DEVICE WAS LOADED UPSIDE DOWN WITH THE CONTRA LIMB LOADED IN THE POSTERIOR POSITION VS ANTERIOR. WHEN PHYSICIAN ROTATED THE SYSTEM TO THE PATIENT'S LEFT THE CONTRA LIMB MAX AND MIN FLOURO MARKERS MOVED TO THE PATIENT RIGHT VS LEFT. THE PHYSICIAN REMEDIED THE SITUATION BY ROTATING THE DEVICE TO THE PATIENTS RIGHT TO ORIENT THE CONTRA LIMB TO THE PATIENTS LEFT AS DESIRED. PHYSICIAN WAS RELYING ON THE MB FLUSH VALVE TO GAUGE ORIENTATION. FURTHER CONVERSATIONS NEED TO BE HAD WITH THE CUSTOMER TO REVIEW HOW WE LOAD OUR GRAFTS INTO THE DELIVERY SYSTEM AND TECHNIQUES FOR CONTRA GATE ORIENTATION. CUSTOMER MENTIONED THAT THIS WOULD BE UNACCEPTABLE ON ANY FUTURE FENESTRATED TECHNOLOGY THAT WE WOULD LAUNCH." PATIENT OUTCOME - "NO CLINICAL SEQUELAE AS THE GRAFT WAS SAFELY DEPLOYED WITH THE DESIRED GATE ORIENTATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1742258 TREO ABDOMINAL STENT-GRAFT SYSTEM STENT, ENDOVASCULAR GRAFT, AORTIC MIH BOLTON MEDICAL, INC. 2309290216

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male