RELAY PRO NBS THORACIC STENT-GRAFT SYSTEM
Report
- Report Number
- 2247858-2025-00182
- Event Type
- Malfunction
- Date Received
- August 1, 2025
- Date of Event
- July 2, 2025
- Report Date
- February 26, 2026
- Manufacturer
- BOLTON MEDICAL, INC.
- Product Code
- MIH
- UDI-DI
- 00843576150591
- PMA / PMN Number
- P200045
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THIS COMPLAINT WAS INVOLVED WITH TWO DEVICES. DEVICE 1 IS BEING REPORTED UNDER MDR-. AND DEVICE 2 IS BEING REPORTED UNDER MDR-2247858-2025-00183. 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.
THIS COMPLAINT WAS INVOLVED WITH TWO DEVICES. DEVICE 1 IS BEING REPORTED UNDER MDR-2247858-2025-00182 AND DEVICE 2 IS BEING REPORTED UNDER MDR-2247858-2025-00183. ALL RELEVANT DEVICE HISTORY RECORDS (DHRS) FOR THE RELAY PRO NBS (N4) THORACIC STENT-GRAFT SYSTEM - DEVICE 1 (28-N4-32-164-32U) WITH FINAL ASSEMBLY LOT# 2503040167 AND RELAY PRO NBS (N4) THORACIC STENT-GRAFT SYSTEM - DEVICE 2 (28-N4-32-104-32U) WITH FINAL ASSEMBLY LOT# 2504220257, 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 DEVICE 1 RECEIVED THE REQUIRED STERILIZATION DOSE ON (B)(6) 2025 AND DEVICE 2 RECEIVED THE REQUIRED STERILIZATION DOSE ON (B)(6) 2025. THERE WERE NO NONCONFORMANCES OR REWORKS IN RELATION TO DEVICES 1 OR 2. THE PATIENT UNDERWENT A THORACIC ENDOVASCULAR REPAIR (TEVAR) PROCEDURE ON (B)(6) 2025 TO TREAT AORTIC DISEASE. TWO RELAYS PRO NBS DEVICES WERE PLANNED TO BE IMPLANTED. THE EVENT NARRATIVE INDICATED THE PATIENT HAD A TORTUOUS DESCENDING AORTIC ANATOMY, WITH A PROXIMAL ANGULAR GOTHIC ARCH ANATOMY. DURING THE ADVANCEMENT OF THE INNER SHEATH TO THE PROXIMAL LANDING ZONE, THE PHYSICIANS FELT RESISTANCE AS THE INNER SHEATH COULD NOT ADVANCE FARTHER. THE DEVICE WAS REMOVED FROM THE PATIENT AND INSPECTED IN WHICH THE OUTER SHEATH WAS OBSERVED TO BE ACCORDIONED. A SECOND RELAY PRO NBS DEVICE WAS USED BUT SIMILAR RESULTS OCCURRED TO THE DELIVERY SYSTEM. A COMPETITOR STENT-GRAFT WAS ULTIMATELY IMPLANTED, AND A RELAY PRO DEVICE WAS EXTENDED DISTALLY. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED NO ISSUES WERE FOUND DURING THE MANUFACTURE OF THE DEVICES. THE PRE-CASE PLAN AND CT IMAGING WERE NOT PROVIDED; NO RESPONSE WAS PROVIDED REGARDING JUSTIFICATION. THE TWO RETURNED RELAY PRO NBS LOADED DELIVERY SYSTEMS WERE EVALUATED. DEVICE 1 (CATALOG # 28-N4-32-104-32U) WAS RECEIVED WITH DAMAGE (ACCORDIONING) TO THE OUTER SHEATH AND WITH THE INNER SHEATH PARTIALLY ADVANCED FROM THE OUTER SHEATH. NO ISSUES WERE OBSERVED DURING FUNCTIONALITY TESTING OF THE SAMPLE. DEVICE 2 (CATALOG # 28-N4-32-164-32U) WAS RECEIVED WITH SOME ACCORDIONING OF THE OUTER SHEATH, NEAR THE DEVICE TIP. THE FUNCTIONALITY COULD NOT BE TESTED BECAUSE THE PUSHROD WAS RECEIVED BROKEN; THEREFORE, THE STENT-GRAFT WAS MANUALLY RELEASED WITH PLIERS. NO ISSUES WERE FOUND WITHIN THE MAIN OR REAR LOCKBODY OF EITHER SAMPLE. DEVICE DEFICIENCY WAS RULED OUT AS POSSIBLE ROOT CAUSE OF THE REPORTED FAILURE. THE EVENT NARRATIVE MENTIONED THE PATIENT HAD A TORTUOUS THORACIC AORTA AND A GOTHIC ARCH ANATOMICAL CONFIGURATION OF THE AORTIC ARCH WHICH APPEARED TO LIMIT THE ADVANCEMENT OF THE DEVICE. THE INSTRUCTIONS FOR USE (RELAY PRO US IFU [2844-8324 REV. G]) WARNS THE USER THAT EXCESSIVE ARTERIAL TORTUOSITY AND/OR DISEASE MAY RESULT IN NOT BEING ABLE TO REACH THE TREATMENT SITE OR RESULT IN THE STENT-GRAFT KINKING. THE PATIENT'S TORTUOUS ANATOMY LIKELY INHIBITED THE INNER SHEATH OF BOTH DEVICES TO REACH THE PROXIMAL LANDING ZONE. WITHOUT THE EVALUATION OF CT IMAGING TO EVALUATE THE PATIENT'S ANATOMY AND STENT-GRAFT SIZING SELECTION, THE ROOT CAUSE OF THE REPORTED FAILURE COULD NOT BE CONFIRMED. IN CONCLUSION, A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED NO ISSUES WERE FOUND DURING THE MANUFACTURE OF THE DEVICES. THE ROOT CAUSE OF THE REPORTED FAILURE OF UNABLE TO ADVANCE THE SECONDARY SHEATH TO THE TREATMENT SITE COULD NOT BE DETERMINED.
SECOND FOLLOW-UP IS BEING SUBMITTED TO CORRECT FIELD G3 THAT WAS INADVERTANTLY LEFT BLANK. THIS COMPLAINT WAS INVOLVED WITH TWO DEVICES. DEVICE 1 IS BEING REPORTED UNDER MDR-2247858-2025-00182 AND DEVICE 2 IS BEING REPORTED UNDER MDR-2247858-2025-00183. ALL RELEVANT DEVICE HISTORY RECORDS (DHRS) FOR THE RELAY PRO NBS (N4) THORACIC STENT-GRAFT SYSTEM - DEVICE 1 (28-N4-32-164-32U) WITH FINAL ASSEMBLY LOT# 2503040167 AND RELAY PRO NBS (N4) THORACIC STENT-GRAFT SYSTEM - DEVICE 2 (28-N4-32-104-32U) WITH FINAL ASSEMBLY LOT# 2504220257, 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 DEVICE 1 RECEIVED THE REQUIRED STERILIZATION DOSE ON (B)(6) 2025 AND DEVICE 2 RECEIVED THE REQUIRED STERILIZATION DOSE ON (B)(6) 2025. THERE WERE NO NONCONFORMANCES OR REWORKS IN RELATION TO DEVICES 1 OR 2. THE PATIENT UNDERWENT A THORACIC ENDOVASCULAR REPAIR (TEVAR) PROCEDURE ON (B)(6) 2025 TO TREAT AORTIC DISEASE. TWO RELAYS PRO NBS DEVICES WERE PLANNED TO BE IMPLANTED. THE EVENT NARRATIVE INDICATED THE PATIENT HAD A TORTUOUS DESCENDING AORTIC ANATOMY, WITH A PROXIMAL ANGULAR GOTHIC ARCH ANATOMY. DURING THE ADVANCEMENT OF THE INNER SHEATH TO THE PROXIMAL LANDING ZONE, THE PHYSICIANS FELT RESISTANCE AS THE INNER SHEATH COULD NOT ADVANCE FARTHER. THE DEVICE WAS REMOVED FROM THE PATIENT AND INSPECTED IN WHICH THE OUTER SHEATH WAS OBSERVED TO BE ACCORDIONED. A SECOND RELAY PRO NBS DEVICE WAS USED BUT SIMILAR RESULTS OCCURRED TO THE DELIVERY SYSTEM. A COMPETITOR STENT-GRAFT WAS ULTIMATELY IMPLANTED, AND A RELAY PRO DEVICE WAS EXTENDED DISTALLY. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED NO ISSUES WERE FOUND DURING THE MANUFACTURE OF THE DEVICES. THE PRE-CASE PLAN AND CT IMAGING WERE NOT PROVIDED; NO RESPONSE WAS PROVIDED REGARDING JUSTIFICATION. THE TWO RETURNED RELAY PRO NBS LOADED DELIVERY SYSTEMS WERE EVALUATED. DEVICE 1 (CATALOG # 28-N4-32-104-32U) WAS RECEIVED WITH DAMAGE (ACCORDIONING) TO THE OUTER SHEATH AND WITH THE INNER SHEATH PARTIALLY ADVANCED FROM THE OUTER SHEATH. NO ISSUES WERE OBSERVED DURING FUNCTIONALITY TESTING OF THE SAMPLE. DEVICE 2 (CATALOG # 28-N4-32-164-32U) WAS RECEIVED WITH SOME ACCORDIONING OF THE OUTER SHEATH, NEAR THE DEVICE TIP. THE FUNCTIONALITY COULD NOT BE TESTED BECAUSE THE PUSHROD WAS RECEIVED BROKEN; THEREFORE, THE STENT-GRAFT WAS MANUALLY RELEASED WITH PLIERS. NO ISSUES WERE FOUND WITHIN THE MAIN OR REAR LOCKBODY OF EITHER SAMPLE. DEVICE DEFICIENCY WAS RULED OUT AS POSSIBLE ROOT CAUSE OF THE REPORTED FAILURE. THE EVENT NARRATIVE MENTIONED THE PATIENT HAD A TORTUOUS THORACIC AORTA AND A GOTHIC ARCH ANATOMICAL CONFIGURATION OF THE AORTIC ARCH WHICH APPEARED TO LIMIT THE ADVANCEMENT OF THE DEVICE. THE INSTRUCTIONS FOR USE (RELAY PRO US IFU [2844-8324 REV. G]) WARNS THE USER THAT EXCESSIVE ARTERIAL TORTUOSITY AND/OR DISEASE MAY RESULT IN NOT BEING ABLE TO REACH THE TREATMENT SITE OR RESULT IN THE STENT-GRAFT KINKING. THE PATIENT'S TORTUOUS ANATOMY LIKELY INHIBITED THE INNER SHEATH OF BOTH DEVICES TO REACH THE PROXIMAL LANDING ZONE. WITHOUT THE EVALUATION OF CT IMAGING TO EVALUATE THE PATIENT'S ANATOMY AND STENT-GRAFT SIZING SELECTION, THE ROOT CAUSE OF THE REPORTED FAILURE COULD NOT BE CONFIRMED. IN CONCLUSION, A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED NO ISSUES WERE FOUND DURING THE MANUFACTURE OF THE DEVICES. THE ROOT CAUSE OF THE REPORTED FAILURE OF UNABLE TO ADVANCE THE SECONDARY SHEATH TO THE TREATMENT SITE COULD NOT BE DETERMINED.
"THE SURGEON ATTEMPTED TO ADVANCE A 32X164 NBS RELAY PRO TO THE PROXIMAL LANDING ZONE. TORTUOUS DESCENDING AORTIC ANATOMY AND PROXIMAL ANGULAR GOTHIC ARCH ANATOMY APPEARED TO LIMIT THE DEVICE'S ABILITY TO REACH THE DESIRED LANDING ZONE. THE DEVICE WOULD NOT ADVANCE, AND THE WIRE WAS STUCK IN THE DELIVERY SYSTEM, (WOULD NOT ADVANCE OR RETRACT). THE SURGEON WAS FORCED TO REMOVE THE DEVICE. UPON INSPECTION THE PROXIMAL ASPECT OF THE DELIVERY SYSTEM WAS DAMAGED AT THE JUNCTION OF THE NOSE CONE AND DELIVERY SYSTEM. THE MID PORTION OF THE OUTER SHEATH WAS "ACCORDIONED", AS WAS THE DISTAL ASPECT OF THE OUTER SHEATH. THE STIFF WIRE WAS AGAIN ADVANCED JUST PROXIMAL TO THE AORTIC VALVE. A SECOND DEVICE WAS ATTEMPTED (32X104 NBS). SIMILAR RESULTS OCCURRED WITH SIGNIFICANT DAMAGE AGAIN OCCURRING TO THE DELIVERY SYSTEM. THE WIRE AGAIN WAS TRAPPED IN THE DELIVERY SYSTEM UNABLE TO RETRACT OR ADVANCE." PATIENT OUTCOME: "TEVAR COMPLETED WITH GORE CTAG PROXIMALLY AND A TERUMO AORTIC RELAY PRO EXTENDED DISTALLY."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 329500 | RELAY PRO NBS THORACIC STENT-GRAFT SYSTEM | STENT, ENDOVASCULAR GRAFT, AORTIC | MIH | BOLTON MEDICAL, INC. | 2503040167 | 00843576150591 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Male |