BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM RELAY NBS PLUS THORACIC STENT-GRAFT SYSTEM

    MDR report key: 18717119 · Received February 15, 2024

    Report

    Report Number
    2247858-2024-00036
    Event Type
    Malfunction
    Date Received
    February 15, 2024
    Date of Event
    January 18, 2024
    Report Date
    June 28, 2024
    Manufacturer
    BOLTON MEDICAL, INC.
    Product Code
    MIH
    PMA / PMN Number
    P110038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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 SPAIN.

    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 PLUS CUSTOM-MADE DEVICE. THE CUSTOM MADE RELAY PLUS DEVICES ARE NOT MARKETED IN THE US, HOWEVER THEY ARE SIMILAR TO THE RELAY THORACIC STENT GRAFT WITH PLUS DELIVERY SYSTEM APPROVED FOR SALE IN THE US (P110038). THE EVENT OCCURRED IN SPAIN.

    Description of Event or Problem · 0

    "THE PROXIMAL CLASPING WAS NOT IN PLACE. SO WHEN ADVANCING THE INNER SHEATH QUE GRAFT GOT DETACHED FROM THE DELIVERY SYSTEM. WHEN WE ADVANCED THE INNER SHEATH AT POSITION 1 WE SAW QUE CONENOSE ADVANCED BUT THE GRAFT WAS DETACHED FROM THE DELIVERY. WE FIRST THOUGHT IT HAS BEEN A PROBLEM OF EXCESSIVE FORCE APPLIED BUT DR. (B)(6) TOLD ME HE DIDN'T APPLY SUCH FORCE. REVIEWING THE PROCEDURE FILM, WE REALISED THE PROXIMAL CLASPING HAD NEVER BEEN CORRECTLY ATTACHED. YOU CAN SEE IT ON THE PICTURE I TOOK FROM THE FILM OR ON THE FILM PROPERLY. WE HAVE BEEN ABLE TO TAKE OUT THE DS WITH NO DAMAGE FOR THE PATIENT." PATIENT OUTCOME: "NO INJURIES FOR THE PATIENT. THE DELIVERY SYSTEM WAS REALIZED WITHOUT PROBLEMS."

    Description of Event or Problem · 0

    "THE PROXIMAL CLASPING WAS NOT IN PLACE. SO WHEN ADVANCING THE INNER SHEATH QUE GRAFT GOT DETACHED FROM THE DELIVERY SYSTEM. WHEN WE ADVANCED THE INNER SHEATH AT POSITION 1 WE SAW QUE CONENOSE ADVANCED BUT THE GRAFT WAS DETACHED FROM THE DELIVERY. WE FIRST THOUGHT IT HAS BEEN A PROBLEM OF EXCESSIVE FORCE APPLIED BUT DR. INARAJA TOLD ME HE DIDN'T APPLY SUCH FORCE. REVIEWING THE PROCEDURE FILM, WE REALISED THE PROXIMAL CLASPING HAD NEVER BEEN CORRECTLY ATTACHED. YOU CAN SEE IT ON THE PICTURE I TOOK FROM THE FILM OR ON THE FILM PROPERLY. WE HAVE BEEN ABLE TO TAKE OUT THE DS WITH NO DAMAGE FOR THE PATIENT." PATIENT OUTCOME: "NO INJURIES FOR THE PATIENT. THE DELIVERY SYSTEM WAS REALIZED WITHOUT PROBLEMS. AN IDENTICAL CUSTOM DEVICE WAS MANUFACTURED AND IMPLANTED IN THE PATIENT WITHOUT ISSUES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62005 CUSTOM RELAY NBS PLUS THORACIC STENT-GRAFT SYSTEM STENT, ENDOVASCULAR GRAFT, AORTIC MIH BOLTON MEDICAL, INC. 2311010473

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Other