RELAY PRO NBS THORACIC STENT-GRAFT SYSTEM
Report
- Report Number
- 2247858-2024-00143
- Event Type
- Injury
- Date Received
- June 25, 2024
- Date of Event
- March 26, 2024
- Report Date
- August 9, 2024
- Manufacturer
- BOLTON MEDICAL, INC.
- Product Code
- MIH
- 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.
"THORAFLEX HYBRID DEVICE INSERTED (B)(4) 2024. AS PER EDC: NO ENDO-LEAK PRESENT AT END OF PROCEDURE, NO ADVERSE EVENTS OR DEVICE DEFICIENCIES DURING PROCEDURE. EXTENSION PROCEDURE PERFORMED ON 2(B)(4) 2024 WITH RELAYPRO NBS. EXTENSION PROCEDURE: TEVAR PROCEDURE - EXTENSION WITH LUMBAR DRAIN. AS PER EDC: AT END OF PROCEDURE: AN ENDOLEAK TYPE 1B WAS PRESENT, ENDOLEAK WAS NOT INTENTIONAL, NO DEVICE DEFICIENCIES OCCURRED DURING THE PROCEDURE VISIT. SITE HAVE NOT COMPLETED AN AE FORM FOR THIS EVENT IN THE EDC OR A DEVICE DEFICIENCY FORM. CRA HAS BEEN CONTACTED TO FOLLOW UP WITH SITE FOR CLARIFICATION. THE SUB-I DR (B)(6) WHO PERFORMED THE IMPLANT HAS CONFIRMED THE FOLLOWING: "I WOULDN'T CONSIDER THIS AN ADVERSE EVENT, AS IT WAS A PLANNED OUTCOME OF THE PROCEDURE."" PATIENT OUTCOME: "PATIENT DISCHARGED FROM ICU ON (B)(6) 2024. PATIENT ATTENDED EXTENSION DISCHARGE/30 DAYS VISIT ON (B)(6) 2024. IMAGING PERFORMED ON (B)(6) 2024 AND UPLOADED TO CORE LAB ON (B)(6) 2024. CORE LAB INDICATE THAT IMAGE PERFORMED ON (B)(6) 2024 HAS NOT BEEN RECEIVED. CORE LAB FOLLOWING UP WITH SITE."
"THORAFLEX HYBRID DEVICE INSERTED 15JAN24. AS PER EDC: NO ENDO-LEAK PRESENT AT END OF PROCEDURE, NO ADVERSE EVENTS OR DEVICE DEFICIENCIES DURING PROCEDURE. EXTENSION PROCEDURE PERFORMED ON (B)(6) 2024 WITH RELAYPRO NBS. EXTENSION PROCEDURE: TEVAR PROCEDURE - EXTENSION WITH LUMBAR DRAIN. AS PER EDC: AT END OF PROCEDURE: AN ENDOLEAK TYPE 1B WAS PRESENT, ENDOLEAK WAS NOT INTENTIONAL, NO DEVICE DEFICIENCIES OCCURRED DURING THE PROCEDURE VISIT. SITE HAVE NOT COMPLETED AN AE FORM FOR THIS EVENT IN THE EDC OR A DEVICE DEFICIENCY FORM. CRA HAS BEEN CONTACTED TO FOLLOW UP WITH SITE FOR CLARIFICATION. THE SUB-I DR OHMAN WHO PERFORMED THE IMPLANT HAS CONFIRMED THE FOLLOWING: "I WOULDN'T CONSIDER THIS AN ADVERSE EVENT, AS IT WAS A PLANNED OUTCOME OF THE PROCEDURE."" PATIENT OUTCOME: "PATIENT DISCHARGED FROM ICU ON (B)(6) 2024. PATIENT ATTENDED EXTENSION DISCHARGE/30 DAYS VISIT ON (B)(6) 24. IMAGING PERFORMED ON (B)(6) 2024 AND UPLOADED TO CORE LAB ON (B)(6) 2024. CORE LAB INDICATE THAT IMAGE PERFORMED ON (B)(6) 2024 HAS NOT BEEN RECEIVED. CORE LAB FOLLOWING UP WITH SITE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2102632 | RELAY PRO NBS THORACIC STENT-GRAFT SYSTEM | STENT, ENDOVASCULAR GRAFT, AORTIC | MIH | BOLTON MEDICAL, INC. | 2308150004 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Male | Other |