RELAY PRO NBS THORACIC STENT-GRAFT SYSTEM
Report
- Report Number
- 2247858-2024-00220
- Event Type
- Injury
- Date Received
- August 27, 2024
- Date of Event
- April 20, 2024
- Report Date
- February 19, 2025
- Manufacturer
- BOLTON MEDICAL, INC.
- Product Code
- MIH
- UDI-DI
- 00843576150799
- PMA / PMN Number
- P200045
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- 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, 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.
"AN EXTENSION PROCEDURE WAS PLANNED BUT NOT AT THE SAME TIME AS THE THORAFLEX HYBRID. THORAFLEX HYBRID WAS IMPLANTED ON (B)(6) 2024. NO DISTAL SEAL WAS INTENDED DUE TO A PLANNED EVAR EXTENSION AND DISTAL SEAL WAS OBTAINED. NO ENDOLEAK WAS PRESENT AT THE END OF THE PROCEDURE. DELIVERY OF THE THORAFLEX HYBRID WAS SUCCESSFUL, DEPLOYED IN PLANNED LOCATION AND WITHDRAWAL OF DELIVERY SYSTEM WAS SUCCESSFUL. NO DEVICE DEFICIENCIES OCCURRED DURING THE INDEX TH PROCEDURE. PATIENT RECEIVED A EXTENSION ON (B)(6) 2024. A RELAY PRO NBS WAS IMPLANTED. THE PROCEDURE WAS ENDOVASCULAR - TEVAR AND RIGHT GROIN CUTDOWN. A TYPE IB ENDOLEAK WAS PRESENT AT THE END OF THE PROCEDURE - THIS WAS INTENTIONAL. NO DEVICE DEFICIENCIES OCCURRED DURING THE PROCEDURE. DELIVERY OF THE STENT GRAFT WAS SUCCESSFUL, DEPLOYED IN PLANNED LOCATION AND WITHDRAWAL OF DELIVERY SYSTEM WAS SUCCESSFUL. EVENT DETAILS: ANEURYSM EXPANSION A FOLLOW UP CT CHEST/ABDOMEN/PELVIS SHOWING ANEURISM EXPANSION TO 8.9CM (AFTER NBS EXTENSION PROCEDURE)." PATIENT OUTCOME: "SURGICAL PROCEDURE CARRIED OUT - TEVAR, 4 VESSEL PMEG, EVAR. AE IS ONGOING, UNRESOLVED STILL TREATING AND THE SUBJECT REMAINS IN THE STUDY."
"AN EXTENSION PROCEDURE WAS PLANNED BUT NOT AT THE SAME TIME AS THE THORAFLEX HYBRID. THORAFLEX HYBRID WAS IMPLANTED ON (B)(6) 2024. NO DISTAL SEAL WAS INTENDED DUE TO A PLANNED EVAR EXTENSION AND DISTAL SEAL WAS OBTAINED. NO ENDOLEAK WAS PRESENT AT THE END OF THE PROCEDURE. DELIVERY OF THE THORAFLEX HYBRID WAS SUCCESSFUL, DEPLOYED IN PLANNED LOCATION AND WITHDRAWAL OF DELIVERY SYSTEM WAS SUCCESSFUL. NO DEVICE DEFICIENCIES OCCURRED DURING THE INDEX TH PROCEDURE. PATIENT RECEIVED A EXTENSION ON (B)(6) 2024. A RELAY PRO NBS WAS IMPLANTED. THE PROCEDURE WAS ENDOVASCULAR - TEVAR AND RIGHT GROIN CUTDOWN. A TYPE IB ENDOLEAK WAS PRESENT AT THE END OF THE PROCEDURE - THIS WAS INTENTIONAL. NO DEVICE DEFICIENCIES OCCURRED DURING THE PROCEDURE. DELIVERY OF THE STENT GRAFT WAS SUCCESSFUL, DEPLOYED IN PLANNED LOCATION AND WITHDRAWAL OF DELIVERY SYSTEM WAS SUCCESSFUL. EVENT DETAILS - ANEURYSM EXPANSION A FOLLOW UP CT CHEST/ABDOMEN/PELVIS SHOWING ANEURISM EXPANSION TO 8.9CM (AFTER NBS EXTENSION PROCEDURE)." PATIENT OUTCOME: "SURGICAL PROCEDURE CARRIED OUT - TEVAR, 4 VESSEL PMEG, EVAR. AE IS ONGOING, UNRESOLVED STILL TREATING AND THE SUBJECT REMAINS IN THE STUDY."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 941616 | RELAY PRO NBS THORACIC STENT-GRAFT SYSTEM | STENT, ENDOVASCULAR GRAFT, AORTIC | MIH | BOLTON MEDICAL, INC. | 2211300190 | 00843576150799 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Male | Other |