BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELAY PRO NBS THORACIC STENT-GRAFT SYSTEM

    MDR report key: 19844955 · Received July 26, 2024

    Report

    Report Number
    2247858-2024-00192
    Event Type
    Injury
    Date Received
    July 26, 2024
    Date of Event
    June 28, 2024
    Report Date
    July 26, 2024
    Manufacturer
    BOLTON MEDICAL, INC.
    Product Code
    MIH
    PMA / PMN Number
    P200045
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    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.

    Description of Event or Problem · 0

    "ENDOLEAK (TYPE 1A): TWO RELAYPRO DEVICES WERE USED IN A STANFORD TYPE B AORTIC DISSECTION CASE AFTER TREATMENT OF AN AORTIC ARCH ANEURYSM WITH DEVICE IMPLANTATION (DETAILS UNKNOWN). AFTER IMPLANTATION OF A RELAYPRO (28-N4-26-104-26U, SERIAL NUMBER: (B)(6) PERIPHERALLY, THE RELAYPRO CONCERNED WAS IMPLANTED CENTRALLY. FINAL ANGIOGRAPHY SHOWED CONTRAST MEDIA FLOWING INTO THE ANEURYSM AND THE FALSE LUMEN OF THE DISSECTION, AND A TYPE 1A ENDOLEAK WAS NOTED. A TRI-LOBE (GORE) WAS USED FOR TOUCH-UP BALLOONING, BUT THE ENDOLEAK WAS NOT RESOLVED AND THE PROCEDURE WAS COMPLETED. OPERATION TYPE: TEVAR ANCILLARY DEVICE: 28-N4-26-104-26U (SERIAL NUMBER: (B)(6). NO IMAGE AVAILABLE DUE TO HOSPITAL POLICY NO PRE-CASE PLAN AVAILABLE DUE TO HOSPITAL POLICY NO ADDITIONAL INFORMATION AVAILABLE DUE TO HOSPITAL POLICY (TC # BM240602633)" PATIENT OUTCOME: "THE DAMAGE TO THE PATIENT'S HEALTH AND THE OUTCOME ARE UNKNOWN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1776388 RELAY PRO NBS THORACIC STENT-GRAFT SYSTEM STENT, ENDOVASCULAR GRAFT, AORTIC MIH BOLTON MEDICAL, INC. 2207080069

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other