BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM MADE RELAY PRO THORACIC STENT-GRAFT SYSTEM

    MDR report key: 20821083 · Received December 2, 2024

    Report

    Report Number
    2247858-2024-00301
    Event Type
    Malfunction
    Date Received
    December 2, 2024
    Date of Event
    November 11, 2024
    Report Date
    March 14, 2025
    Manufacturer
    BOLTON MEDICAL, INC.
    Product Code
    MIH
    PMA / PMN Number
    P200045
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. 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 THE NETHERLANDS.

    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. 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. 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 THE NETHERLANDS.

    Description of Event or Problem · 0

    "AFTER POSITIONING STIFF GUIDEWIRE (LESDC) IN ZONE 0, DEVICE WAS ADVANCED UP UNTIL UPPER DESCENDING AORTA. WITH CALCULATED C-ARM ANGULATION DEVICE WAS ROTATED TO OBTAIN CORRECT POSITION. MARKERS OF SCALLOP VS D-SHAPED MARKER WERE SLIGHTLY CONFUSING ("DID THEY APPLY THE 30° POSTERIOR OFFSET TO THE SCALLOP OR TO THE D-SHAPED MARKER?"). WHEN DEVICE WAS ADVANCED INTO THE AORTIC ARCH IT WAS CLEAR THAT THE REQUESTED OFFSET WAS INCORRECT. THE OFFSET FOR THE PROXIMAL SCALLOP APPEARED TO BE 30° ANTERIOR INSTEAD OF POSTERIOR. OR THEY APPLIED THE POSTERIOR OFFSET TO THE D-SHAPED MARKER. ALL ATTEMPTS AT THAT STAGE TO CORRECT THE POSITION OF THE GRAFT/SCALLOP UNFORTUNATELY FAILED TO ACHIEVE THE DESIRED ROTATION. THE RIGIDITY, TORTUOSITY AND RESISTANCE OF THE THORAFLEXHYBRID IN-SITU MADE THE DELIVERY SYSTEM (WITH ITS PRE-CURVED INNER NITINOL CATHETER AND LONG TIP OF THE DEVICE) ROTATE/FLIP BACK TO A PREFERRED POSITION OVER AND OVER AGAIN. WHICH WOULD HAVE BEEN OKAY IF THE PROXIMAL SCALLOP HAD A POSTERIOR OFFSET." PATIENT OUTCOME: "AFTER DISCUSSING SEVERAL OPTIONS, IT WAS DECIDED TO DEPLOY THE CM RELAY JUST DISTAL TO THE LCCA AND PROVIDE FLOW TO THE LSA THROUGH A CHIMNEY GRAFT (ADVANTA V12). THIS SOLUTION PROVIDED FLOW TO THE SUPRA-AORTIC TRUNKS. FURTHER FOLLOW-UP IMAGING WILL BE PERFORMED TO ASSESS IF THIS IS ADEQUATE TREATMENT FOR THIS PATIENT."

    Description of Event or Problem · 0

    "AFTER POSITIONING STIFF GUIDEWIRE (LESDC) IN ZONE 0, DEVICE WAS ADVANCED UP UNTIL UPPER DESCENDING AORTA. WITH CALCULATED C-ARM ANGULATION DEVICE WAS ROTATED TO OBTAIN CORRECT POSITION. MARKERS OF SCALLOP VS D-SHAPED MARKER WERE SLIGHTLY CONFUSING ("DID THEY APPLY THE 30° POSTERIOR OFFSET TO THE SCALLOP OR TO THE D-SHAPED MARKER?"). WHEN DEVICE WAS ADVANCED INTO THE AORTIC ARCH IT WAS CLEAR THAT THE REQUESTED OFFSET WAS INCORRECT. THE OFFSET FOR THE PROXIMAL SCALLOP APPEARED TO BE 30° ANTERIOR INSTEAD OF POSTERIOR. OR THEY APPLIED THE POSTERIOR OFFSET TO THE D-SHAPED MARKER. ALL ATTEMPTS AT THAT STAGE TO CORRECT THE POSITION OF THE GRAFT/SCALLOP UNFORTUNATELY FAILED TO ACHIEVE THE DESIRED ROTATION. THE RIGIDITY, TORTUOSITY AND RESISTANCE OF THE THORAFLEXHYBRID IN-SITU MADE THE DELIVERY SYSTEM (WITH ITS PRE-CURVED INNER NITINOL CATHETER AND LONG TIP OF THE DEVICE) ROTATE/FLIP BACK TO A PREFERRED POSITION OVER AND OVER AGAIN. WHICH WOULD HAVE BEEN OKAY IF THE PROXIMAL SCALLOP HAD A POSTERIOR OFFSET." PATIENT OUTCOME: "AFTER DISCUSSING SEVERAL OPTIONS, IT WAS DECIDED TO DEPLOY THE CM RELAY JUST DISTAL TO THE LCCA AND PROVIDE FLOW TO THE LSA THROUGH A CHIMNEY GRAFT (ADVANTA V12). THIS SOLUTION PROVIDED FLOW TO THE SUPRA AORTIC TRUNKS. FURTHER FOLLOW-UP IMAGING WILL BE PERFORMED TO ASSESS IF THIS IS ADEQUATE TREATMENT FOR THIS PATIENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303946 CUSTOM MADE RELAY PRO THORACIC STENT-GRAFT SYSTEM STENT, ENDOVASCULAR GRAFT, AORTIC MIH BOLTON MEDICAL, INC. 2409270189

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Other