BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELAY PRO NBS THORACIC STENT-GRAFT SYSTEM

    MDR report key: 17813968 · Received September 25, 2023

    Report

    Report Number
    2247858-2023-00251
    Event Type
    Malfunction
    Date Received
    September 25, 2023
    Date of Event
    September 6, 2023
    Report Date
    October 12, 2023
    Manufacturer
    BOLTON MEDICAL INC.
    Product Code
    MIH
    PMA / PMN Number
    P200045
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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

    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

    "UNABLE TO DEPLOY THE STENT GRAFT: ALTHOUGH USUAL TAR WAS ORIGINALLY PLANNED, HEMOSTASIS ON THE DISTAL SIDE WAS DIFFICULT AND THE PHYSICIAN DECIDED TO ADD A RELAYPRO STENT-GRAFT TO THE DISTAL SIDE URGENTLY. AS A J GRAFT (4 GB, JAPAN LIFELINE) WAS 26 MM AND THE NATIVE BLOOD VESSEL DIAMETER ON THE DISTAL SIDE WAS ABOUT 25 MM, THE RELAYPRO STENT-GRAFT (28-N4-32-164-28U) WAS ATTEMPTED TO BE DEPLOYED AS PER THE IFU. HOWEVER, THE FEMALE PHYSICIAN COULD NOT PULL THE APEX HOLDER KNOB TOWARDS THE DISTAL SIDE WITH HER STRENGTH, AND AN ASSISTANT PHYSICIAN PULLED THE APEX HOLDER KNOB WITH ALL HIS STRENGTH TO DEPLOY THE STENT-GRAFT. THE STENT-GRAFT WAS DEPLOYED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PHYSICIAN'S COMMENTS: IF THE STENT-GRAFT CANNOT BE DEPLOYED BY A FEMALE PHYSICIAN'S STRENGTH, IT WOULD BE DIFFICULT TO USE THE PRODUCT. OPERATION TYPE: TAR + TEVAR. BLOOD LOSS: LARGE AMOUNT. NO IMAGE AVAILABLE. NO PRE-CASE PLAN AVAILABLE. NO ADDITIONAL INFORMATION AVAILABLE. (TC#BM230900692)". PATIENT OUTCOME: "NO HEALTH DAMAGE TO THE PATIENT.".

    Description of Event or Problem · 0

    "UNABLE TO DEPLOY THE STENT GRAFT: ALTHOUGH USUAL TAR WAS ORIGINALLY PLANNED, HEMOSTASIS ON THE DISTAL SIDE WAS DIFFICULT AND THE PHYSICIAN DECIDED TO ADD A RELAYPRO STENT-GRAFT TO THE DISTAL SIDE URGENTLY. AS A J GRAFT (4 GB, JAPAN LIFELINE) WAS 26 MM AND THE NATIVE BLOOD VESSEL DIAMETER ON THE DISTAL SIDE WAS ABOUT 25 MM, THE RELAYPRO STENT-GRAFT (28-N4-32-164-28U) WAS ATTEMPTED TO BE DEPLOYED AS PER THE IFU. HOWEVER, THE FEMALE PHYSICIAN COULD NOT PULL THE APEX HOLDER KNOB TOWARDS THE DISTAL SIDE WITH HER STRENGTH, AND AN ASSISTANT PHYSICIAN PULLED THE APEX HOLDER KNOB WITH ALL HIS STRENGTH TO DEPLOY THE STENT-GRAFT. THE STENT-GRAFT WAS DEPLOYED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PHYSICIAN'S COMMENTS: IF THE STENT-GRAFT CANNOT BE DEPLOYED BY A FEMALE PHYSICIAN'S STRENGTH, IT WOULD BE DIFFICULT TO USE THE PRODUCT. OPERATION TYPE: TAR + TEVAR. BLOOD LOSS: LARGE AMOUNT. NO IMAGE AVAILABLE. NO PRE-CASE PLAN AVAILABLE. NO ADDITIONAL INFORMATION AVAILABLE. ((B)(4))". PATIENT OUTCOME: "NO HEALTH DAMAGE TO THE PATIENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1974454 RELAY PRO NBS THORACIC STENT-GRAFT SYSTEM STENT, ENDOVASCULAR GRAFT, AORTIC MIH BOLTON MEDICAL INC. 2110250340

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown