BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELAY PRO THORACIC STENT-GRAFT SYSTEM

    MDR report key: 17025351 · Received May 30, 2023

    Report

    Report Number
    2247858-2023-00132
    Event Type
    Malfunction
    Date Received
    May 30, 2023
    Date of Event
    May 9, 2023
    Report Date
    October 2, 2023
    Manufacturer
    BOLTON MEDICAL INC.
    Product Code
    MIH
    PMA / PMN Number
    P200045
    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.

    Description of Event or Problem · 0

    "RELAY PRO NBS NAVIGATE THE THORACIC AORTA IN STEP 1 WITH MECHANICAL ADVANTAGE, CLINICIAN MOVED IN STEP 2 AND TRY TO USE MECHANICAL ADVANTAGE AND GREY KNOB (USING THE DISENGAGEMENT BUTTON), TO RETRACT THE CONSTRAINING SLEEVE AND DEPLOYS THE GRAFT, BUT HE NOTICED A BENDING OF THE TIP WITHOUT RELEASING OF THE INNER SHEATH. HE TRIED TO COME BACK IN STEP 1 TO RETRACT THE DEVICE AS SOON AS POSSIBLE INTO OUTER SHEATH BUT HE HAD AGAIN THE BENDING OF THE TIP. HE TRIED TO MOVE IN THE DEVICE ALSO IN STEP 4 WITHOUT CONSEQUENCE, SO HO RETRACT THE ENTIRE SYSTEM INTO ABDOMINAL AORTA AND CONVERT THE PATIENT: HE REMOVED HALF THE DEVICE FROM ABOVE AND HALF FROM BELOW (FEMORAL ACCESS). MAIN CLINICIAN REPORT IS THAT STEP 2 DIDN'T WORK.". PATIENT OUTCOME - "ABDOMINAL AORTA WAS EXPOSE AND THE DEVICE REMOVED HALF FROM THE AORTA AND HALF INTO FEMORAL ACCESS.".

    Description of Event or Problem · 0

    "RELAY PRO NBS NAVIGATE THE THORACIC AORTA IN STEP 1 WITH MECHANICAL ADVANTAGE, CLINICIAN MOVED IN STEP 2 AND TRY TO USE MECHANICAL ADVANTAGE AND GREY KNOB (USING THE DISENGAGEMENT BUTTON), TO RETRACT THE CONSTRAINING SLEEVE AND DEPLOYS THE GRAFT, BUT HE NOTICED A BENDING OF THE TIP WITHOUT RELEASING OF THE INNER SHEATH. HE TRIED TO COME BACK IN STEP 1 TO RETRACT THE DEVICE AS SOON AS POSSIBLE INTO OUTER SHEATH BUT HE HAD AGAIN THE BENDING OF THE TIP. HE TRIED TO MOVE IN THE DEVICE ALSO IN STEP 4 WITHOUT CONSEQUENCE, SO HO RETRACT THE ENTIRE SYSTEM INTO ABDOMINAL AORTA AND CONVERT THE PATIENT: HE REMOVED HALF THE DEVICE FROM ABOVE AND HALF FROM BELOW (FEMORAL ACCESS). MAIN CLINICIAN REPORT IS THAT STEP 2 DIDN'T WORK." PATIENT OUTCOME - "ABDOMINAL AORTA WAS EXPOSE AND THE DEVICE REMOVED HALF FROM THE AORTA AND HALF INTO FEMORAL ACCESS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1575519 RELAY PRO THORACIC STENT-GRAFT SYSTEM STENT, ENDOVASCULAR GRAFT, AORTIC MIH BOLTON MEDICAL INC. B210602369

    Patients

    Seq Age Sex Outcome Treatment
    1 99 YR Unknown Other