BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUSTOM-MADE RELAY PRO THORACIC STENT-GRAFT SYSTEM

    MDR report key: 21055105 · Received January 2, 2025

    Report

    Report Number
    2247858-2025-00002
    Event Type
    Injury
    Date Received
    January 2, 2025
    Date of Event
    November 29, 2024
    Report Date
    June 10, 2025
    Manufacturer
    BOLTON MEDICAL, INC.
    Product Code
    MIH
    PMA / PMN Number
    P200045
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT WAS INVOLVED WITH TWO DEVICES. DEVICE 1 IS BEING REPORTED UNDER MDR 2247858-2025-00001, AND DEVICE 2 IS BEING REPORTED UNDER MDR 2247858-2025-00002. 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 CANADA. 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.

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT WAS INVOLVED WITH TWO DEVICES. DEVICE 1 IS BEING REPORTED UNDER MDR 2247858-2025-00001, AND DEVICE 2 IS BEING REPORTED UNDER MDR 2247858-2025-00002. BOLTON MEDICAL IS VOLUNTARILY REPORTING AN EVENT RELATED TO BOTH TREO AND RELAY PRO CUSTOM-MADE DEVICES. THE CUSTOM-MADE TREO AND RELAY PRO DEVICES ARE NOT MARKETED IN THE US, HOWEVER THEY ARE SIMILAR TO THE TREO ABDOMINAL STENT GRAFT DELIVERY SYSTEM APPROVED FOR SALE IN THE US (P190015) AND THE RELAY THORACIC STENT GRAFT SYSTEM WITH PRO DELIVERY SYSTEM APPROVED FOR SALE IN THE US (P200045), RESPECTIVELY. THE EVENT OCCURRED IN CANADA. 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

    "IN THE CLINICIAN'S OPINION, WHAT WAS THE CAUSE OF THIS EVENT? IS THIS EVENT RELATED TO A DEVICE FAILURE/DEFICIENCY? POSSIBLY. IS THIS EVENT RELATED TO THE PROCEDURE? NO. IS THIS EVENT RELATED TO A PRE-EXISTING CONDITION? YES. WAS SURGICAL INTERVENTION REQUIRED? NO. DUE TO TORTUOSITY AND FRICTION THE SHEATH WAS CRIMPED' OR PUFFED UP SO UNINTENDED PREMATURE RELEASE OF THE IPSI LEG OCCURRED. WHICH RESULTED IN LIMITED CONTROL IN TORTUOUS ANATOMY. THERE WAS A MISALIGNMENT OF THE GRAFT PROXIMAL AND DISTALLY, BOTH SIDES RESPONDED DIFFERENTLY. END RESULT WAS SUCCESSFUL CANNULATION FOR BOTH RENAL AND SMA. CA IS NOT CANNULATED AND CREATED ALSO AN ENDOLEAK AFTERWARDS. THIS WILL BE ADDRESSED IN A SECOND STAGE NOW. ALSO, THE OVERLAP BETWEEN CM TEVAR (PAT 5200) AND THE FEVAR (PAT 5199-B1) WAS INSUFFICIENT AND A COOK TEVAR IS PLACED TO COMBINE BOTH DEVICES PROPERLY. SEE BELOW CLARIFYING QUESTIONS: 1. PREMATURE RELEASE OF THE IPSI LEG: DID YOU MEAN PREMATURE RELEASE OF THE IPSILATERAL GATE, OR A TREO LEG DEPLOYED ON THE IPSI SIDE? IF TREO LEG, PLEASE PROVIDE LOT # AND CATALOG #. RESPONSE: PREMATURE RELEASE OF THE IPSILATERAL GATE RESULTED IN LOSS OF CONTROL FOR REPOSITIONING. 2. MISALIGNMENT OF THE GRAFT PROXIMAL AND DISTALLY, BOTH SIDES RESPONDED DIFFERENTLY: PLEASE CAN YOU ELABORATE (IS THIS THE CUSTOM FEVAR). RESPONSE: THE FENESTRATED TREO HAS GOT CIRCUMFERENTIAL TIES AND TOGETHER WITH THE PROXIMAL AND DISTAL FIXATION ON THE IPSI LEG ITS DESIGNED TO HAVE CONTROL OF THE DEVICE. HOWEVER, DUE TO THE TORTUOUS ANATOMY THE DEVICE WAS PUSHING DOWNWARDS DUE TO THE TIP OF THE DEVICE WAS POINTING INTO A CURVE. AND BECAUSE WE LOST THE IPSILATERAL GATE FIXATION THE DEVICE DIDN'T ROTATE AS ONE PIECE. ALSO CALLED CANDY WRAPPING. 3. ENDOLEAK: WHICH TYPE OF ENDOLEAK? WHICH GRAFT? RESPONSE: ENDOLEAK TYPE 3C DUE TO THE FACT THE BRIDGING STENT WAS NOT DEPLOYED. 4. INSUFFICIENT OVERLAP BETWEEN THE TWO DEVICES. WAS THERE A MISPLACEMENT OF ONE OF THE TWO GRAFTS (WHICH GRAFT) OR PROVIDE REASON. RESPONSE: DUE TO THE TORTUOUS ANATOMY AND THE ISSUES DESCRIBED BEFORE, THE WHOLE GRAFT WAS PRESSED TOGETHER FROM BOTH PROXIMAL AND DISTAL. IN OTHER WORDS, THE PROXIMAL LENGTH WAS LESS AND DUE TO AN ANGLE DIFFERENCE THERE WAS TO LESS PROXIMAL OVERLAP." PATIENT OUTCOME: "HIGH RADIATION + ENDOLEAK THROUGH UNSTENTED CA WHICH NEED TO BE ADDRESSED IN SECOND INTERVENTION."

    Description of Event or Problem · 0

    "IN THE CLINICIAN'S OPINION, WHAT WAS THE CAUSE OF THIS EVENT? IS THIS EVENT RELATED TO A DEVICE FAILURE/DEFICIENCY? POSSIBLY IS THIS EVENT RELATED TO THE PROCEDURE? NO IS THIS EVENT RELATED TO A PRE-EXISTING CONDITION? YES WAS SURGICAL INTERVENTION REQUIRED? NO. DUE TO TORTUOSITY AND FRICTION, THE SHEATH WAS CRIMPED' OR PUFFED UP SO UNINTENDED PREMATURE RELEASE OF THE IPSI LEG OCCURRED. WHICH RESULTED IN LIMITED CONTROL IN TORTUOUS ANATOMY. THERE WAS A MISALIGNMENT OF THE GRAFT PROXIMAL AND DISTALLY, BOTH SIDES RESPONDED DIFFERENTLY. END RESULT WAS SUCCESSFUL CANNULATION FOR BOTH RENAL AND SMA. CA IS NOT CANNULATED AND CREATED ALSO AN ENDOLEAK AFTERWARDS. THIS WILL BE ADDRESSED IN A SECOND STAGE NOW. ALSO, THE OVERLAP BETWEEN CM TEVAR (PAT 5200) AND THE FEVAR (PAT 5199-B1) WAS INSUFFICIENT AND A COOK TEVAR IS PLACED TO COMBINE BOTH DEVICES PROPERLY. SEE BELOW CLARIFYING QUESTIONS: 1.PERMATURE RELEASE OF THE IPSI LEG: DID YOU MEAN PREMATURE RELEASE OF THE IPSILATERAL GATE, OR A TREO LEG DEPLOYED ON THE IPSI SIDE? IF TREO LEG, PLEASE PROVIDE LOT # AND CATALOG #. RESPONSE: PREMATURE RELEASE OF THE IPSILATERAL GATE RESULTED IN LOSS OF CONTROL FOR REPOSITIONING. 2.MISALIGNMENT OF THE GRAFT PROXIMAL AND DISTALLY, BOTH SIDES RESPONDED DIFFERENTLY: PLEASE CAN YOU ELABORATE (IS THIS THE CUSTOM FEVAR). RESPONSE: THE FENESTRATED TREO HAS GOT CIRCUMFERENTIAL TIES AND TOGETHER WITH THE PROXIMAL AND DISTAL FIXATION ON THE IPSI LEG ITS DESIGNED TO HAVE CONTROL OF THE DEVICE. HOWEVER, DUE TO THE TORTUOUS ANATOMY THE DEVICE WAS PUSHING DOWNWARDS DUE TO THE TIP OF THE DEVICE WAS POINTING INTO A CURVE. AND BECAUSE WE LOST THE IPSILATERAL GATE FIXATION THE DEVICE DIDN'T ROTATE AS ONE PIECE. ALSO CALLED CANDY WRAPPING. 3. ENDOLEAK: WHICH TYPE OF ENDOLEAK? WHICH GRAFT? RESPONSE: ENDOLEAK TYPE 3C DUE TO THE FACT THE BRIDGING STENT WAS NOT DEPLOYED. 4.INSUFFICIENT OVERLAP BETWEEN THE TWO DEVICES. WAS THERE A MISPLACEMENT OF ONE OF THE TWO GRAFTS (WHICH GRAFT) OR PROVIDE REASON. RESPONSE: DUE TO THE TORTUOUS ANATOMY AND THE ISSUES DESCRIBED BEFORE, THE WHOLE GRAFT WAS PRESSED TOGETHER FROM BOTH PROXIMAL AND DISTAL. IN OTHER WORDS, THE PROXIMAL LENGTH WAS LESS AND DUE TO AN ANGLE DIFFERENCE THERE WAS TO LESS PROXIMAL OVERLAP." PATIENT OUTCOME: "HIGH RADIATION + ENDOLEAK THROUGH UNSTENTED CA WHICH NEED TO BE ADDRESSED IN SECOND INTERVENTION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1322829 CUSTOM-MADE RELAY PRO THORACIC STENT-GRAFT SYSTEM STENT, ENDOVASCULAR GRAFT, AORTIC MIH BOLTON MEDICAL, INC. 2409110394

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male Other| R