BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELAY PRO THORACIC STENT-GRAFT SYSTEM

    MDR report key: 22349897 · Received June 27, 2025

    Report

    Report Number
    2247858-2025-00157
    Event Type
    Injury
    Date Received
    June 27, 2025
    Date of Event
    June 2, 2025
    Report Date
    April 2, 2026
    Manufacturer
    BOLTON MEDICAL, INC
    Product Code
    MIH
    UDI-DI
    00843576150362
    PMA / PMN Number
    P200045
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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.

    Additional Manufacturer Narrative · 0

    DURING AN INTERNAL REVIEW, BOLTON MEDICAL, INC. DETERMINED THAT THE APPLICABLE STANDARD OPERATING PROCEDURE DID NOT CLEARLY DEFINE THE REPORTING TIMELINES FOR SUPPLEMENTAL MDRS. WE HAVE INITIATED CORRECTIVE ACTIONS TO ADDRESS THIS GAP AND WILL BE DOCUMENTED IN OUR QUALITY SYSTEM UNDER CAPA-2026-0002. ALL RELEVANT DEVICE HISTORY RECORDS (DHRS) FOR THE RELAY PRO (M4) THORACICL STENT-GRAFT SYSTEM (28-M4-38-250-34U) WITH FINAL ASSEMBLY LOT# 2401040276, 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 JANUARY 11, 2024. THERE WERE NO NONCONFORMANCES OR REWORKS IN RELATION TO THE DEVICE. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED NO ISSUES WERE FOUND DURING THE MANUFACTURE OF THE DEVICE. THE DEVICE WAS NOT RETURNED FOR INVESTIGATION. AS INDICATED IN THE NARRATIVE, IMAGING WAS NOT AVAILABLE DUE TO HOSPITAL POLICY. THE PRE-CASE PLAN WAS PROVIDED FOR REVIEW WHICH SHOWS MILD CALCIFICATION IN THE ENTRY VESSELS AND SEVERE TORTUOSITY ALONG THE AORTA. ACCORDING TO THE EVENT NARRATIVE, THE PATIENT HAD A PREVIOUSLY IMPLANTED COMPETITOR GRAFT, IN WHICH THE REPORTED RELAY PRO DEVICE BECAME CAUGHT ON. IT IS LIKELY THAT THIS, ALONG WITH THE TORTUOSITY PRESENT IN THE PRE-CASE PLAN, WAS THE REASON FOR THE DIFFICULTY ADVANCING THE DEVICE THROUGH THE AORTA. AFTER THE PROCEDURE, THE PATIENT EXPERIENCED PARAPLEGIA IN BOTH LEGS. PARAPLEGIA MAY BE CAUSED BY SPINAL CORD ISCHEMIA. ISCHEMIA (SPINAL CORD, PERFUSION PATHWAYS) IS A POTENTIAL ADVERSE EVENT OF TEVAR PROCEDURES. TO ALLEVIATE THE PATIENT'S CONDITION, A SPINAL DRAINAGE WAS INSERTED. WITHOUT POST-OPERATIVE CT SCANS OR ADDITIONAL INFORMATION TO EVALUATE THE PATIENT'S ANATOMY AND CONDITION, IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE POST-OPERATIVE PARAPLEGIA. IN CONCLUSION, REVIEW OF THE DEVICE HISTORY RECORDS SHOWED NO ISSUES WERE FOUND DURING THE MANUFACTURING OF THE DEVICE. THE ROOT CAUSE OF THE REPORTED FAILURE OF ADVANCING THE DEVICE THROUGH THE AORTA WAS A COMBINATION OF THE TORTUOSITY IN THE PATIENT'S ANATOMY AND THE PREVIOUSLY IMPLANTED COMPETITOR GRAFT. THE ROOT CAUSE OF THE REPORTED FAILURE OF PARAPLEGIA COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    ALL RELEVANT DEVICE HISTORY RECORDS (DHRS) FOR THE RELAY PRO (M4) THORACICL STENT-GRAFT SYSTEM (28-M4-38-250-34U) WITH FINAL ASSEMBLY LOT# 2401040276, 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) 2024. THERE WERE NO NONCONFORMANCES OR REWORKS IN RELATION TO THE DEVICE. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED NO ISSUES WERE FOUND DURING THE MANUFACTURE OF THE DEVICE. THE DEVICE WAS NOT RETURNED FOR INVESTIGATION. AS INDICATED IN THE NARRATIVE, IMAGING WAS NOT AVAILABLE DUE TO HOSPITAL POLICY. THE PRE-CASE PLAN WAS PROVIDED FOR REVIEW WHICH SHOWS MILD CALCIFICATION IN THE ENTRY VESSELS AND SEVERE TORTUOSITY ALONG THE AORTA. ACCORDING TO THE EVENT NARRATIVE, THE PATIENT HAD A PREVIOUSLY IMPLANTED COMPETITOR GRAFT, IN WHICH THE REPORTED RELAY PRO DEVICE BECAME CAUGHT ON. IT IS LIKELY THAT THIS, ALONG WITH THE TORTUOSITY PRESENT IN THE PRE-CASE PLAN, WAS THE REASON FOR THE DIFFICULTY ADVANCING THE DEVICE THROUGH THE AORTA. AFTER THE PROCEDURE, THE PATIENT EXPERIENCED PARAPLEGIA IN BOTH LEGS. PARAPLEGIA MAY BE CAUSED BY SPINAL CORD ISCHEMIA. ISCHEMIA (SPINAL CORD, PERFUSION PATHWAYS) IS A POTENTIAL ADVERSE EVENT OF TEVAR PROCEDURES. TO ALLEVIATE THE PATIENT'S CONDITION, A SPINAL DRAINAGE WAS INSERTED. WITHOUT POST-OPERATIVE CT SCANS OR ADDITIONAL INFORMATION TO EVALUATE THE PATIENT'S ANATOMY AND CONDITION, IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE POST-OPERATIVE PARAPLEGIA. IN CONCLUSION, REVIEW OF THE DEVICE HISTORY RECORDS SHOWED NO ISSUES WERE FOUND DURING THE MANUFACTURING OF THE DEVICE. THE ROOT CAUSE OF THE REPORTED FAILURE OF ADVANCING THE DEVICE THROUGH THE AORTA WAS A COMBINATION OF THE TORTUOSITY IN THE PATIENT'S ANATOMY AND THE PREVIOUSLY IMPLANTED COMPETITOR GRAFT. THE ROOT CAUSE OF THE REPORTED FAILURE OF PARAPLEGIA COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    "UNABLE TO ADVANCE THE INNER SHEATH / PARAPLEGIA (SUSPECTED) ON SATURDAY, (B)(6), TAR + FET WAS PERFORMED FOR THE ARCH AND DESCENDING AORTIC ANEURYSM. (J GRAFT (26 MM, JAPAN LIFELINE)) AND FROZENIX (35 MM × 120 MM, JAPAN LIFELINE). ON MONDAY, (B)(6), TEVAR WAS PERFORMED USING THE RELAY PRO STENT GRAFT. CUTDOWN WAS PERFORMED IN THE RIGHT FA. A DRYSEAL (22 FR, GORE) WAS INSERTED. THE RELAY PRO STENT GRAFT (28-M4-38-250-34U) WAS INSERTED. THE INNER SHEATH OF THE STENT GRAFT WAS ATTEMPTED TO BE ADVANCED THROUGH THE IMPLANTED FROZENIX STENT GRAFT, BUT THE DELIVERY SYSTEM TIP WAS CAUGHT IN THE PERIPHERAL PORTION OF THE FROZENIX, WHICH CAUSED DIFFICULTY ADVANCING THE RELAY PRO. IT WAS DETERMINED THAT THE RELAY PRO COULD NOT BE DELIVERED ANY FURTHER; THEREFORE, THE IMPLANTATION PLAN WAS CHANGED. FIRST, THE RELAY PRO WOULD BE IMPLANTED IN THE INITIALLY INTENDED PERIPHERAL LOCATION, AND THEN ANOTHER STENT WOULD BE STACKED. THE RELAY PRO WAS SUCCESSFULLY IMPLANTED SLIGHTLY ABOVE THE CELIAC ARTERY. A CTAG (40 × 200, GORE) WAS SELECTED AS THE STACKED STENT GRAFT. THE TIP OF THE CTAG WAS ALSO CAUGHT IN THE PERIPHERAL PORTION OF THE FROZENIX. HOWEVER, THE CTAG COULD BE ADVANCED MORE CENTRALLY THAN THE RELAY PRO, AND THE CTAG WAS IMPLANTED. TOUCH-UP WAS PERFORMED WITH A TRI-LOBE BALLOON CATHETER (GORE). NO ENDOLEAK WAS OBSERVED. THE PATIENT WAS AWAKE FROM ANESTHESIA BUT HAD POOR MOVEMENT IN BOTH LEGS. SPINAL DRAINAGE WAS INSERTED. THE PATIENT WAS RETURNED TO THE ICU. OPERATION TYPE: TEVAR NO BLOOD LOSS ANCILLARY DEVICE USED: CTAG (40 × 200, GORE). NO IMAGE AVAILABLE DUE TO HOSPITAL POLICY PRE-CASE PLAN AVAILABLE (SEE THE ATTACHED SCHEMA) NO ADDITIONAL INFORMATION AVAILABLE DUE TO HOSPITAL POLICY. (TC# (B)(4). PATIENT OUTCOME: "THE PATIENT HAD POOR MOVEMENT IN BOTH LEGS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360993 RELAY PRO THORACIC STENT-GRAFT SYSTEM STENT, ENDOVASCULAR GRAFT, AORTIC MIH BOLTON MEDICAL, INC 2401040276 00843576150362

    Patients

    Seq Age Sex Outcome Treatment
    1