RELAY PRO NBS THORACIC STENT-GRAFT SYSTEM
Report
- Report Number
- 2247858-2024-00300
- Event Type
- Injury
- Date Received
- December 2, 2024
- Report Date
- January 24, 2025
- Manufacturer
- BOLTON MEDICAL, INC.
- Product Code
- MIH
- PMA / PMN Number
- P200045
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- 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.
"ABDOMINAL ORGAN ISCHEMIA DUE TO OCCLUSION OF THE CELIAC ARTERY: THE RELAY PRO STENT-GRAFT WAS IMPLANTED TO TREAT A DESCENDING AORTIC ANEURYSM ON OCTOBER 4. THE STENT-GRAFT WAS IMPLANTED RIGHT ABOVE THE CELIAC ARTERY. DURING IMPLANTATION, THE CELIAC ARTERY WAS ABOUT TO BE SLIGHTLY COVERED, BUT IT WAS AVOIDED BY PUSHING UP THE STENT-GRAFT. AS INTRAOPERATIVE ANGIOGRAPHY SHOWED THAT CONTRAST MEDIA FLOWED INTO THE CELIAC ARTERY AS WELL AND THAT THERE WAS NO ENDOLEAK IN THE ANEURYSM, THE PROCEDURE WAS COMPLETED. ABOUT TWO WEEKS AFTER THE PROCEDURE, THE PATIENT COMPLAINED OF ABDOMINAL PAIN. A RE-EXAMINATION REVEALED THAT THE CELIAC ARTERY WAS COVERED, CAUSING ORGAN FAILURE. THE PATIENT UNDERWENT A GASTRECTOMY AND IS CURRENTLY RECOVERING. PHYSICIAN'S COMMENT ON CAUSALITY: ALTHOUGH THERE WAS A CONCERN ABOUT THE POSITION OF THE STENT-GRAFT IMPLANTED, THIS FAILURE WAS DUE TO THE PROCEDURE. PHYSICIAN'S COMMENT: ACCORDING TO PAPERS AND OTHERS, THE INCIDENCE OF ORGAN FAILURE DUE TO CELIAC ARTERY OCCLUSION IS LESS THAN 3%, WHICH IS QUITE LOW. THEREFORE, THE PHYSICIAN WAS AWARE THAT THERE WOULD BE NO PROBLEM EVEN IF THE ARTERY WAS OCCLUDED. ALTHOUGH INTRAOPERATIVE ANGIOGRAPHY SHOWED THAT CONTRAST MEDIA WAS FLOWING INTO THE CELIAC ARTERY, IT IS UNKNOWN WHETHER THE ARTERY WAS COVERED DUE TO STENT-GRAFT MIGRATION AFTER THE PROCEDURE. DURING THE RE-EXAMINATION, NO CONTRAST MEDIUM WAS FLOWING INTO THE CELIAC ARTERY. OPERATION TYPE: TEVAR. BLOOD LOSS: UNKNOWN. NO IMAGE AVAILABLE DUE TO HOSPITAL POLICY. NO PRE-CASE PLAN AVAILABLE DUE TO HOSPITAL POLICY. NO ADDITIONAL INFORMATION AVAILABLE DUE TO HOSPITAL POLICY. (TC#B(B)(4))". PATIENT OUTCOME: "THE PATIENT IS RECOVERING."
"ABDOMINAL ORGAN ISCHEMIA DUE TO OCCLUSION OF THE CELIAC ARTERY: THE RELAY PRO STENT-GRAFT WAS IMPLANTED TO TREAT A DESCENDING AORTIC ANEURYSM ON OCTOBER 4. THE STENT-GRAFT WAS IMPLANTED RIGHT ABOVE THE CELIAC ARTERY. DURING IMPLANTATION, THE CELIAC ARTERY WAS ABOUT TO BE SLIGHTLY COVERED, BUT IT WAS AVOIDED BY PUSHING UP THE STENT-GRAFT. AS INTRAOPERATIVE ANGIOGRAPHY SHOWED THAT CONTRAST MEDIA FLOWED INTO THE CELIAC ARTERY AS WELL AND THAT THERE WAS NO ENDOLEAK IN THE ANEURYSM, THE PROCEDURE WAS COMPLETED. ABOUT TWO WEEKS AFTER THE PROCEDURE, THE PATIENT COMPLAINED OF ABDOMINAL PAIN. A RE-EXAMINATION REVEALED THAT THE CELIAC ARTERY WAS COVERED, CAUSING ORGAN FAILURE. THE PATIENT UNDERWENT A GASTRECTOMY AND IS CURRENTLY RECOVERING. PHYSICIAN'S COMMENT ON CAUSALITY: ALTHOUGH THERE WAS A CONCERN ABOUT THE POSITION OF THE STENT-GRAFT IMPLANTED, THIS FAILURE WAS DUE TO THE PROCEDURE. PHYSICIAN'S COMMENT: ACCORDING TO PAPERS AND OTHERS, THE INCIDENCE OF ORGAN FAILURE DUE TO CELIAC ARTERY OCCLUSION IS LESS THAN 3%, WHICH IS QUITE LOW. THEREFORE, THE PHYSICIAN WAS AWARE THAT THERE WOULD BE NO PROBLEM EVEN IF THE ARTERY WAS OCCLUDED. ALTHOUGH INTRAOPERATIVE ANGIOGRAPHY SHOWED THAT CONTRAST MEDIA WAS FLOWING INTO THE CELIAC ARTERY, IT IS UNKNOWN WHETHER THE ARTERY WAS COVERED DUE TO STENT-GRAFT MIGRATION AFTER THE PROCEDURE. DURING THE RE-EXAMINATION, NO CONTRAST MEDIUM WAS FLOWING INTO THE CELIAC ARTERY. OPERATION TYPE: TEVAR. BLOOD LOSS: UNKNOWN. NO IMAGE AVAILABLE DUE TO HOSPITAL POLICY. NO PRE-CASE PLAN AVAILABLE DUE TO HOSPITAL POLICY. NO ADDITIONAL INFORMATION AVAILABLE DUE TO HOSPITAL POLICY. (B)(4). PATIENT OUTCOME: "THE PATIENT IS RECOVERING."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 338043 | RELAY PRO NBS THORACIC STENT-GRAFT SYSTEM | STENT, ENDOVASCULAR GRAFT, AORTIC | MIH | BOLTON MEDICAL, INC. | 2311210265 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other| R |