BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELAY PRO THORACIC STENT-GRAFT SYSTEM

    MDR report key: 17063846 · Received June 5, 2023

    Report

    Report Number
    2247858-2023-00140
    Event Type
    Malfunction
    Date Received
    June 5, 2023
    Date of Event
    May 15, 2023
    Report Date
    July 7, 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 DEVICE WAS OPENED AND PREPPED AS NORMAL. DEVICE WAS INSERTED AND ADVANCED DISTAL OF DISTAL DELIVERY ZONE. PRODUCT WAS DEPLOYED IN POSITION 1 WITHOUT ISSUE TO THE TARGETED LANDING ZONE (LCCA). DEVICE WAS CHANGED TO POSITION TWO AND DEPLOYED IN POSITION 2 WITHOUT INCIDENT. DURING THE STEP 3 PORTION OF THE DEPLOYMENT SEQUENCE THE BLACK PORTION OF THE RELEASE WAS ROTATED 90 DEGREES BUT THE SCRUB TECH HAD DIFFICULTY PULLING IT BACK TO RELEASE THE TIP RETAINER. SHE TRIED SEVERAL TIMES USING ADDITIONAL FORCE WITH HER HAND AND IT STILL WOULD NOT RELEASE. UPON INSTRUCTING HER TO "PULL HARDER" AND USE TWO HANDS SHE WAS FINALLY ABLE TO RELEASE THE APEX RELEASE AND IT POPPED - HOWEVER THE TECH NOTED IT TOOK EXCESSIVE FORCE. THE PHYSICIAN MADE A JOKE ABOUT THE SITUATION BUT CLEARLY IT REQUIRED EXCESSIVE FORCE." PATIENT OUTCOME - "AS OF THIS TIME, NO ADVERSE OUTCOME OCCURRED TO THE PATIENT."

    Description of Event or Problem · 0

    "RELAY PRO DEVICE WAS OPENED AND PREPPED AS NORMAL. DEVICE WAS INSERTED AND ADVANCED DISTAL OF DISTAL DELIVERY ZONE. PRODUCT WAS DEPLOYED IN POSITION 1 WITHOUT ISSUE TO THE TARGETED LANDING ZONE (LCCA). DEVICE WAS CHANGED TO POSITION TWO AND DEPLOYED IN POSITION 2 WITHOUT INCIDENT. DURING THE STEP 3 PORTION OF THE DEPLOYMENT SEQUENCE THE BLACK PORTION OF THE RELEASE WAS ROTATED 90 DEGREES BUT THE SCRUB TECH HAD DIFFICULTY PULLING IT BACK TO RELEASE THE TIP RETAINER. SHE TRIED SEVERAL TIMES USING ADDITIONAL FORCE WITH HER HAND AND IT STILL WOULD NOT RELEASE. UPON INSTRUCTING HER TO "PULL HARDER" AND USE TWO HANDS SHE WAS FINALLY ABLE TO RELEASE THE APEX RELEASE AND IT POPPED - HOWEVER THE TECH NOTED IT TOOK EXCESSIVE FORCE. THE PHYSICIAN MADE A JOKE ABOUT THE SITUATION BUT CLEARLY IT REQUIRED EXCESSIVE FORCE." PATIENT OUTCOME: "AS OF THIS TIME, NO ADVERSE OUTCOME OCCURRED TO THE PATIENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    735308 RELAY PRO THORACIC STENT-GRAFT SYSTEM STENT, ENDOVASCULAR GRAFT, AORTIC MIH BOLTON MEDICAL, INC. 2302070100

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female