BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM-MADE RELAY PRO NBS THORACIC STENT-GRAFT SYSTEM

    MDR report key: 20000289 · Received August 19, 2024

    Report

    Report Number
    2247858-2024-00209
    Event Type
    Malfunction
    Date Received
    August 19, 2024
    Date of Event
    July 22, 2024
    Report Date
    December 16, 2024
    Manufacturer
    BOLTON MEDICAL, INC.
    Product Code
    MIH
    PMA / PMN Number
    P200045
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 RELAY PRO CUSTOM-MADE DEVICE. THE CUSTOM MADE RELAY PRO DEVICES ARE NOT MARKETED IN THE US, HOWEVER THEY ARE SIMILAR TO THE RELAY THORACIC STENT GRAFT WITH PRO DELIVERY SYSTEM APPROVED FOR SALE IN THE US (P200045). THE EVENT OCCURRED IN GERMANY.

    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 RELAY PRO CUSTOM-MADE DEVICE. THE CUSTOM MADE RELAY PRO DEVICES ARE NOT MARKETED IN THE US, HOWEVER THEY ARE SIMILAR TO THE RELAY THORACIC STENT GRAFT WITH PRO DELIVERY SYSTEM APPROVED FOR SALE IN THE US (P200045). THE EVENT OCCURRED IN GERMANY.

    Description of Event or Problem · 0

    "WINDOW MARKER NOT CORRECTLY ALIGNED. PROTHESIS SEEMS TO HAVE AN ANTERIOR LOADING. CHECKED BEFORE INSERTION OUTSIDE OF THE PATIENT. MISALIGNMENT CONSIDERED NOT BE SEVERE. INSERTED AND RELEASED. LCCA STENTED AS FIRST. AFTERWARDS NOT POSSIBLE TO GET INTO THE BCT DUE TO SEVERE ANTERIOR ROTATION AND SLIGHTLY COVERED BCT. CHIMNEY PERFORMED. PATIENT SURVIVED. OUTCOME UNKNOWN. IN THE CLINICIAN'S OPINION WHAT WAS THE CAUSE OF THIS EVENT (PLEASE TICK ONE BOX PER LINE) DEVICE: POSSIBLY, PROCEDURE: POSSIBLY, PRE-EXISTING CONDITION: POSSIBLY. PATIENT OUTCOME: "NO INFO YET."

    Description of Event or Problem · 0

    "WINDOW MARKER NOT CORRECTLY ALIGNED. PROTHESIS SEEMS TO HAVE AN ANTERIOR LOADING. CHECKED BEFORE INSERTION OUTSIDE OF THE PATIENT. MISALIGNMENT CONSIDERED NOT BE SEVERE. INSERTED AND RELEASED. LCCA STENTED AS FIRST. AFTERWARDS NOT POSSIBLE TO GET INTO THE BCT DUE TO SEVERE ANTERIOR ROTATION AND SLIGHTLY COVERED BCT. CHIMNEY PERFORMED. PATIENT SURVIVED. OUTCOME UNKNOWN IN THE CLINICIAN'S OPINION WHAT WAS THE CAUSE OF THIS EVENT (PLEASE TICK ONE BOX PER LINE) DEVICE - POSSIBLY, PROCEDURE - POSSIBLY, PRE-EXISTING CONDITION - POSSIBLY". PATIENT OUTCOME: "NO INFO YET".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1342745 CUSTOM-MADE RELAY PRO NBS THORACIC STENT-GRAFT SYSTEM STENT, ENDOVASCULAR GRAFT, AORTIC MIH BOLTON MEDICAL, INC. 2404290469

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other