CUSTOM-MADE RELAY PRO NBS THORACIC STENT-GRAFT SYSTEM
Report
- Report Number
- 2247858-2025-00082
- Event Type
- Malfunction
- Date Received
- March 19, 2025
- Date of Event
- February 28, 2025
- Report Date
- June 3, 2025
- Manufacturer
- BOLTON MEDICAL, INC.
- Product Code
- MIH
- PMA / PMN Number
- P200045
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
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 FRANCE.
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 FRANCE.
"WHEN WE DRIVE THE DEVICE THROW THE AORTA, IN POSITION 1, WE MOVE TO GET THE FINAL POSITION WITH THE FLEXIBLE INNER SHEATH BY TURNING THE BLACK HANDLE. SUDDENLY, WE SHOW THE PROXIMAL RELAY DB PART OPENING ALONE, LIKE IF THE FLEXIBLE INNER SHEATH WAS BLOCKED. IN FACT, WE CAN'T MOVE TO DELIVERY POSITION, THE RELAY WAS BLOCK IN THE AORTA. AT THIS STEP, WE WAS AT THE FRONT OF BCT ARTERY WITH THE RELAY DB. (LCCA COVERED) AS THE ENDPROTHESIS CAN'T MOVE TO THE DELIVERY POINT, WE MOVE BACK IT TO BE AWARE THE CEREBRAL TRUNK. WE ARRIVED MOVE BACK THE RELAY DB IN THORACIC AORTA DISSECTION WITHOUT DISEASES FOR THE PATIENT. THE SURGEON MAKE A CHEMINEY FOR LCCA WITH STANDARD THORACIC GORE PUT NEAR THE BCT ARTERY AND ICOVER STENT IN LCCA WITH START AT THE PROXIMAL OF THORACIC GORE. THEN THE CONTROL WAS NOT BAD AND WE FINISH THE OR. I HAVE THE CT PICTURE RECORD ON THE ROOM COMPUTER (NOT ALL)." PATIENT OUTCOME: "NO CONSEQUENCES IMMEDIATE. NO IMMEDIATE CONSEQUENCES UNTIL HE HAD AN ALTERNATIVE TREATMENT WHICH CAN EVOLUTE IN THE TIME."
"WHEN WE DRIVE THE DEVICE THROW THE AORTA, IN POSITION 1, WE MOVE TO GET THE FINAL POSITION WITH THE FLEXIBLE INNER SHEATH BY TURNING THE BLACK HANDLE. SUDDENLY, WE SHOW THE PROXIMAL RELAY DB PART OPENING ALONE, LIKE IF THE FLEXIBLE INNER SHEATH WAS BLOCKED. IN FACT, WE CAN'T MOVE TO DELIVERY POSITION, THE RELAY WAS BLOCK IN THE AORTA. AT THIS STEP, WE WAS AT THE FRONT OF BCT ARTERY WITH THE RELAY DB. (LCCA COVERED) AS THE ENDOPROSTHESIS CAN'T MOVE TO THE DELIVERY POINT, WE MOVE BACK IT TO BE AWARE THE CEREBRAL TRUNK. WE ARRIVED MOVE BACK THE RELAY DB IN THORACIC AORTA DISSECTION WITHOUT DISEASES FOR THE PATIENT. THE SURGEON MAKE A CHEMINEY FOR LCCA WITH STANDARD THORACIC GORE PUT NEAR THE BCT ARTERY AND ICOVER STENT IN LCCA WITH START AT THE PROXIMAL OF THORACIC GORE. THEN THE CONTROL WAS NOT BAD AND WE FINISH THE OR. I HAVE THE CT PICTURE RECORD ON THE ROOM COMPUTER (NOT ALL)." PATIENT OUTCOME: "NO CONSEQUENCES IMMEDIATE. NO IMMEDIATE CONSEQUENCES UNTIL HE HAD AN ALTERNATIVE TREATMENT WHICH CAN EVOLUTE IN THE TIME."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 797216 | CUSTOM-MADE RELAY PRO NBS THORACIC STENT-GRAFT SYSTEM | STENT, ENDOVASCULAR GRAFT, AORTIC | MIH | BOLTON MEDICAL, INC. | 2501150225 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Male | Required Intervention |