BEUDAMED
    FDA Adverse Event Death Summary report: N

    RELAY PRO NBS THORACIC STENT-GRAFT SYSTEM

    MDR report key: 24587015 · Received March 12, 2026

    Report

    Report Number
    2247858-2026-00028
    Event Type
    Death
    Date Received
    March 12, 2026
    Date of Event
    February 12, 2026
    Report Date
    April 28, 2026
    Manufacturer
    BOLTON MEDICAL, INC.
    Product Code
    MIH
    PMA / PMN Number
    P200045
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ALL RELEVANT DEVICE HISTORY RECORDS (DHRS) FOR THE RELAY PRO NBS (N4) THORACIC STENT-GRAFT SYSTEM (28-N4-34-209-34S) WITH FINAL ASSEMBLY LOT# B250422040, INCLUDING FINAL ASSEMBLY (LABELING), STENT-GRAFT SYSTEM/PACKAGING, DELIVERY SYSTEM ASSEMBLY AND STENT-GRAFT ASSEMBLY, WERE INSPECTED AND NO DISCREPANCIES WERE FOUND. NO DISCREPANCIES WERE NOTED IN THE QC INSPECTIONS PERFORMED WITHIN THE CORRESPONDING SUB-ASSEMBLY AND FINAL ASSEMBLY PROCESSES. STERILIZATION RECORDS SHOW THE DEVICE RECEIVED THE REQUIRED STERILIZATION DOSE ON (B)(6) 2025. THERE WERE NO NONCONFORMANCES OR REWORKS IN RELATION TO THIS DEVICE. THE PATIENT UNDERWENT A THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR) PROCEDURE ON FEBRUARY 12, 2026, IN WHICH THE PHYSICIAN ATTEMPTED TO IMPLANT A RELAY PRO NBS (CATALOG # 28-N4-34-209-34S) STENT-GRAFT TO TREAT A PENETRATING THORACIC ULCER. THE EVENT NARRATIVE INDICATED THE PROXIMAL CLASP WAS UNABLE TO BE RELEASED TO COMPLETELY DEPLOY THE STENT-GRAFT BUT THE APEX RELEASE GRIP WAS ABLE TO BE RETRACTED WITHOUT ISSUE. THE PHYSICIAN ATTEMPTED BAILOUT TECHNIQUES TO RELEASE THE PROXIMAL CLASP BUT INDICATED IT WAS NOT POSSIBLE TO REMOVE THE DELIVERY SYSTEM AND STENT-GRAFT FROM THE PATIENT WITHOUT COMPROMISING THE IMPLANTED ENDOPROSTHETIC SEGMENT. THE PATIENT PASSED AWAY IN THE OPERATING ROOM AFTER MULTIPLE ATTEMPTS AT TECHNICAL MANEUVERS FOR THE REMOVAL OF THE ENDOPROSTHETIC SEGMENT AND RESUSCITATION. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED NO ISSUES WERE FOUND DURING THE MANUFACTURE OF THE DEVICE. THE DELIVERY SYSTEM WAS RETURNED FOR INVESTIGATION UNDER RGA # 105586. THE RETURNED DELIVERY SYSTEM WAS EVALUATED BY THE QUALITY ENGINEERING TEAM ON FEBRUARY 20, 2026. THE DEVICE WAS RECEIVED WITH THE SUPPORT TUBE CUT, AND THE APEX RELEASE CLASP MECHANISM WAS NOT RETURNED AS IT WAS REMOVED FROM THE DEVICE DURING THE PROCEDURE. THE OUTER AND INNER CONTROL TUBES WERE RECEIVED REMOVED FROM THE DELIVERY SYSTEM. THE EXPLANTED STENT-GRAFT WAS RECEIVED WITH THE PROXIMAL STENT STILL CLASPED WITHIN THE DISTAL CLASP AND PROXIMAL CLASP. THE DISTAL END OF THE OUTER CONTROL TUBE (OCT) WAS STILL ATTACHED AT THE BONDING JOINT OF THE PROXIMAL CLASP, INDICATING A FRACTURE OF THE OCT. THE PRONGS OF THE PROXIMAL CLASP WERE ALSO FOUND TO BE BENT. THE BENT PRONG ON THE PROXIMAL CLASP LIKELY OCCURRED DURING THE PROCEDURE DURING THE BAILOUT ATTEMPTS BUT IT COULD NOT BE CONFIRMED. A REVIEW OF PREVIOUS COMPLAINTS OF A SIMILAR FAILURE MODE SHOWED COMPLAINT NUMBER TAA-1403 WAS REPORTED FOR THE FAILURE MODE OF OCT BREAKAGE FROM THE PROXIMAL CLASP. UPON RECEIVING COMPLAINT NUMBER TAA-1403, AWARENESS TRAINING WAS PROVIDED FOR THE CORRESPONDING MANUFACTURING ASSOCIATES ON SEPTEMBER 29, 2025, REGARDING THE REPORTED FAILURE. ADDITIONALLY, CAPA-2025-0045 WAS OPENED TO FURTHER INVESTIGATE AND ADDRESS THE ISSUE OF OCT BREAKAGE FROM THE PROXIMAL CLASP. CONSIDERING POSSIBLE ROOT CAUSES OF THE OCT BREAKAGE, IMMEDIATE CORRECTIVE ACTIONS HAVE BEEN IMPLEMENTED ON NOVEMBER 18, 2025, UNDER CAPA-2025-0045, WHICH INCLUDE THE FOLLOWING PROCESS CHANGES TO MANUFACTURING INSTRUCTIONS MI-0211: CLARIFIED SANDING PROCESS OF THE OCT AND ADDED ADDITIONAL REFERENCE PICTURES. CLARIFIED GLUE APPLICATION PROCESS ON THE OCT TO ATTACH THE PROXIMAL CLASP AND ADDED ADDITIONAL REFERENCE PICTURES. REMOVAL OF INSTRUCTIONS ON USING RAZOR TO REMOVE EXCESS GLUE AFTER CURING. UNITS WITH EXCESS ADHESIVE ARE QUARANTINED BY QUALITY TO DETERMINE DISPOSITION OF THE ASSEMBLY. THE COMPLAINT DEVICE OF TAA-1486 WAS MANUFACTURED ON APRIL 26, 2025, PRIOR TO THE AWARENESS TRAINING PROVIDED TO THE CORRESPONDING MANUFACTURING OPERATORS AND PRIOR TO THE IMMEDIATE CORRECTIVE ACTIONS IMPLEMENTED ON NOVEMBER 18, 2025, UNDER CAPA-2025-0045. FURTHER CORRECTIVE ACTIONS REGARDING THE REPORTED FAILURE INCLUDE THE PLANNING OF A DESIGN CHANGE OF THE PROXIMAL CLASP ASSEMBLY TO MITIGATE THE OCCURRENCE OF THE FAILURE MODE IN THE FIELD. IN CONCLUSION, A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED NO ISSUES WERE FOUND DURING THE MANUFACTURE OF THE DEVICE. THE ROOT CAUSE OF THE REPORTED FAILURE MODE OF INABILITY TO RELEASE THE PROXIMAL STENTS COULD NOT BE DETERMINED. CAPA-2025-0045 WAS OPENED TO FURTHER INVESTIGATE AND ADDRESS THE ISSUE OF OCT BREAKAGE FROM THE PROXIMAL CLASP. THE ROOT CAUSE OF THE REPORTED FAILURE OF INTRA-OPERATIVE PATIENT DEATH WAS PROCEDURE-RELATED COMPLICATIONS BUT COULD NOT BE FURTHER SPECIFIED.

    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

    "IMPLANT OF THORACIC ENDOPROSTHESIC IN NON-BARE STENT CONFIGURATION AS A SECOND COMPONENT WITHIN THE FIRST IMPLANTED ENDOPROSTHETIC COMPONENT: THE DELIVERY SYSTEM IS INTRODUCED INTO THE RIGHT FEMORAL SEGMENT, THE SYSTEM IS ADVANCED, THE INNER SHEATH IS ADVANCED, AND IT IS DEPLOYED AT THE SITE UNDER FLUOROSCOPIC GUIDANCE. THE PROXIMAL GLASPING IS RELEASED, OBSERVING UNDER FLUOROSCOPY THE DOWNWARD DISPLACEMENT OF THE SUPPORT WIRES. THE FINAL STEP IS PERFORMED TO RETRIEVE THE TIP OF THE DELIVERY SYSTEM, OBSERVING UNDER FLUOROSCOPY THE ANCHORING OF TWO APEXES OF THE PROXIMAL STENT WITHIN THE PROXIMAL CAPTURE. MANEUVERS AIMED AT ACHIEVING PROXIMAL RELEASE WERE UNSUCCESSFUL. ADDITIONAL BAILOUT TECHNIQUES WERE FOLLOW AND THE DELIVERY WAS CUT AT ITS DISTAL SEGMENT INDICATED IN THE GUIDES, HOLDING THE NITINOL CORE WITHOUT ACHIEVING RESULTS. AFTER MULTIPLE MANEUVERS, THE RELEASE OF THE PROXIMAL CAPTURE WAS NOT SUCCESSFUL, WITHOUT THE POSSIBILITY OF WITHDRAWING FROM THE DELIVERY SYSTEM WITHOUT COMPROMISING THE IMPLANTED ENDOPROSTHETIC SEGMENT." PATIENT OUTCOME: "THE PATIENT DIED IN THE OPERATING ROOM, AFTER MULTIPLE ATTEMPTS ATE TECHNICAL MANEUVERS FOR THE REMOVAL OF THE ENDOPROSTHETIC SEGMENT AND RESUSCITATION".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568333 RELAY PRO NBS THORACIC STENT-GRAFT SYSTEM STENT, ENDOVASCULAR GRAFT, AORTIC MIH BOLTON MEDICAL, INC. B250422040

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Death