BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELAY PRO THORACIC STENT-GRAFT SYSTEM

    MDR report key: 24308260 · Received February 10, 2026

    Report

    Report Number
    2247858-2026-00015
    Event Type
    Malfunction
    Date Received
    February 10, 2026
    Date of Event
    January 14, 2026
    Report Date
    February 10, 2026
    Manufacturer
    BOLTON MEDICAL, INC.
    Product Code
    MIH
    UDI-DI
    00843576149830
    PMA / PMN Number
    P200045
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    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

    "PATIENT HAD PREVIOUS THORACIC GRAFTS IMPLANTED IN ARCH DUE TO PREVIOUS (FAILED) REPAIR. BECAUSE OF PATIENT'S MECHANICAL VALVE, AND IN ORDER TO GET PUSHABILITY OF THE RELAY THROUGH DIFFICULT ANGLES IN THE ARCH, WE CHOSE TO DEPLOY THE 44X150 RELAY PRO BMS FROM THE PATIENT'S R AXILLARY, THROUGH A 22F DRY SEAL. THE 22F DRY SEAL WAS INSERTED IN THE R AXILLARY WIT THE TIP HAVING TRAVERSED THE INNOMINATE ARTERY AND WAS IN THE ASCENDING AORTA DIRECTED TOWARD THE DESCENDING THORACIC AORTA. THE 44X150 RELAY PRO BMS WAS INSERTED IN THE DRY SEAL, TAKING THE DEVICE OUT OF STEP 1 WHILE IN THE DRY SEAL, AND WAS MANUALLY CRANKED (NO BUTTON QUICK RELEASE WAS USED), TO THE DESIRED LANDING ZONE WITH NO ISSUE. WE PUT THE DEVICE INTO STEP 2 AND THE GRAFT FLOWERED AS EXPECTED. WHEN WE ATTEMPTED STEP 3, THE BLACK PIN WOULD NOT COME BACK ALL THE WAY TO MATE WITH THE GRAY PIECE. DR (B)(6) HAS DEPLOYED HUNDREDS OF RELAY PROS AND HAS NEVER BEEN UNABLE TO PULL THE BACK PIN ALL THE WAY. IT SIMPLY WOULD NOT COME BACK MORE THAN 2-3MM BEFORE BOUNCING BACK TO THE ORIGINAL POSITION. HE USED HEMOSTATS AND STILL COULD NOT PULL IT BACK. AFTER SOME TROUBLE, WE WERE ABLE TO ACCESS THE "WINDOW" UNDER THE STEP 3 PIN, AND WRENCH IT OPEN. HE WAS ABLE TO TAKE HEMOSTATS AND PULL THE GREEN HYPO TUBE, ACCIDENTALLY SEVERING THE HYPO TUBE AND WIRE IN THE PROCESS. HE THEN USED HEMOSTATS TO GRASP THE GREEN HYPO TUBE (WITH THE PROXIMAL WIRE NOW RECOILED INSIDE THE CATHETER) AND PULL VERY HARD TO GET THE BARE STENTS TO RELEASE. IN DOING SO, AND WHILE TRYING TO RETRACT THE NOSE CONE, (OVER A SEVERED WIRE), THE NOSE CONE WAS LEFT ON THE WIRE IN THE AORTA AND WAS DISCONNECTED FROM THE DEPLOYMENT SYSTEM. AFTER SOME TROUBLE, WE WERE ABLE TO RECAPTURE THE NOSE CONE. UNFORTUNATELY, IN THE PANIC OF THE CASE, THE NOSE CONE WAS LOST IN THE TRASH. I AM RETURNING THE REST OF THE DEPLOYMENT SYSTEM." PATIENT OUTCOME: "DEVICE WAS IMPLANTED AND PATIENT DID NOT SUFFER AN ADVERSE OUTCOME DUE TO THIS INCIDENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370323 RELAY PRO THORACIC STENT-GRAFT SYSTEM STENT, ENDOVASCULAR GRAFT, AORTIC MIH BOLTON MEDICAL, INC. 2403080394 00843576149830

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male