BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELAY PRO THORACIC STENT-GRAFT SYSTEM

    MDR report key: 16715636 · Received April 11, 2023

    Report

    Report Number
    2247858-2023-00091
    Event Type
    Malfunction
    Date Received
    April 11, 2023
    Date of Event
    March 13, 2023
    Report Date
    August 9, 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

    WHILE IMPLANTING THE 3RD PIECE WHICH WAS A 40/40X250 RELAY PRO GRAFT, IN STEP 2 DEPLOYING THE STENT AND BRINGING BACK THE SECONDARY SHEATH IT BECAME EXTREMELY DIFFICULT FOR THE DOCTOR TO MANAGE. WE WERE UNABLE TO PRESS THE BLACK RELEASE BUTTON AND SLIDE THE MECHANICAL ADVANTAGE TOWARD THE BACK OF THE DEVICE TO RELEASE THE ENTIRE GRAFT. WE USED THE MECHANICAL ADVANTAGE TO DEPLOY THE ENTIRE GRAFT. WHEN WE REACHED THE BACK OF THE DEPLOYMENT SYSTEM ABOUT 3 STENTS WE STILL CONSTRAINED WITHIN THE SECONDARY SHEATH. WE RELEASED THE TOP OF THE GRAFT IN STEP 3. THEN MOVED INTO 4 ON THE DEPLOYMENT, BROUGHT STAINLESS STEEL ROD BACK AS FAR AS WE COULD. NEXT, WE WENT BACK INTO 1 AND ADVANCE THE TIP OF THE DEVICE ABOUT 3CM. NEXT WE WENT BACK INTO 2 ON THE DEPLOYMENT SYSTEM AND USED THE MECHANICAL ADVANTAGE TO PULL THE SECONDARY SHEATH BACK AS FAR AS WE COULD, THIS ALLOWED THE STENT TO COMPLETELY DEPLOY. WHILE THIS WAS HAPPENING DO TO BP AND ELONGATED TIME OF THE 3RD (40/40X250) NOT BEING TOTALLY DEPLOYED OUR PROXIMAL PIECE MOVED DISTALLY FROM OUR PROXIMAL LANDING ZONE, WHICH RESULTED IN US HAVING TO PUT A 4TH PIECE IN TO REGAIN SEAL. PATIENT OUTCOME - "PT WAS FINE AFTER THE CASE MOTOR FUNCTION AT THE TIME OF BEING EXTABATED WAS GOOD AND PHYSICIAN WAS OVER ALL HAPPY WITH THE RESULT OF THE CASE."

    Description of Event or Problem · 0

    WHILE IMPLANTING THE 3RD PIECE WHICH WAS A 40/40X250 RELAY PRO GRAFT, IN STEP 2 DEPLOYING THE STENT AND BRINGING BACK THE SECONDARY SHEATH IT BECAME EXTREMELY DIFFICULT FOR THE DOCTOR TO MANAGE. WE WERE UNABLE TO PRESS THE BLACK RELEASE BUTTON AND SLIDE THE MECHANICAL ADVANTAGE TOWARD THE BACK OF THE DEVICE TO RELEASE THE ENTIRE GRAFT. WE USED THE MECHANICAL ADVANTAGE TO DEPLOY THE ENTIRE GRAFT. WHEN WE REACHED THE BACK OF THE DEPLOYMENT SYSTEM ABOUT 3 STENTS WE STILL CONSTRAINED WITHIN THE SECONDARY SHEATH. WE RELEASED THE TOP OF THE GRAFT IN STEP 3. THEN MOVED INTO 4 ON THE DEPLOYMENT, BROUGHT STAINLESS STEEL ROD BACK AS FAR AS WE COULD. NEXT, WE WENT BACK INTO 1 AND ADVANCE THE TIP OF THE DEVICE ABOUT 3CM. NEXT WE WENT BACK INTO 2 ON THE DEPLOYMENT SYSTEM AND USED THE MECHANICAL ADVANTAGE TO PULL THE SECONDARY SHEATH BACK AS FAR AS WE COULD, THIS ALLOWED THE STENT TO COMPLETELY DEPLOY. WHILE THIS WAS HAPPENING DO TO BP AND ELONGATED TIME OF THE 3RD (40/40X250) NOT BEING TOTALLY DEPLOYED OUR PROXIMAL PIECE MOVED DISTALLY FROM OUR PROXIMAL LANDING ZONE, WHICH RESULTED IN US HAVING TO PUT A 4TH PIECE IN TO REGAIN SEAL. PATIENT OUTCOME - "PT WAS FINE AFTER THE CASE MOTOR FUNCTION AT THE TIME OF BEING EXTABATED WAS GOOD AND PHYSICIAN WAS OVER ALL HAPPY WITH THE RESULT OF THE CASE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1623657 RELAY PRO THORACIC STENT-GRAFT SYSTEM STENT, ENDOVASCULAR GRAFT, AORTIC MIH BOLTON MEDICAL, INC. 2202230299

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Other