CUSTOM-MADE TREO ABDOMINAL STENT-GRAFT SYSTEM
Report
- Report Number
- 2247858-2025-00007
- Event Type
- Malfunction
- Date Received
- January 15, 2025
- Date of Event
- December 19, 2024
- Report Date
- April 1, 2025
- Manufacturer
- BOLTON MEDICAL, INC.
- Product Code
- MIH
- PMA / PMN Number
- P190015
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
BOLTON MEDICAL IS VOLUNTARILY REPORTING AN EVENT RELATED TO A TREO CUSTOM-MADE DEVICE. THE CUSTOM MADE TREO DEVICES ARE NOT MARKETED IN THE US, HOWEVER THEY ARE SIMILAR TO THE TREO ABDOMINAL STENT GRAFT DELIVERY SYSTEM APPROVED FOR SALE IN THE US (P190015). THE EVENT OCCURRED IN THE NETHERLANDS. 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 TREO CUSTOM-MADE DEVICE. THE CUSTOM MADE TREO DEVICES ARE NOT MARKETED IN THE US, HOWEVER THEY ARE SIMILAR TO THE TREO ABDOMINAL STENT GRAFT DELIVERY SYSTEM APPROVED FOR SALE IN THE US (P190015). THE EVENT OCCURRED IN THE NETHERLANDS. 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.
"THE SAND COLOURED BLOCK ATTACHED TO THE NITINOL WIRE WASN'T ATTACHED TO THE DELIVERY SYSTEM. THE BLOCK WAS FLOATING THE LEFT LATERAL MARKER WAS ON THE RIGHT SIDE DURING INITIAL X-RAY THE NITINOL DRT WIRE WAS STUCK TO THE NOSE CONE. WE LEFT THE SAND COLOURED BLOCK HANGING BESIDES THE DELIVERY SYSTEM, NO ISSUES WE CHECKED THE ANTERIOR AND POSTERIOR MARKERS AND PLACED THE DEVICE, BASED ON THIS, THE LEFT LATERAL MARKER MOVED TO THE LEFT DURING/AFTER DEPLOYMENT WHEN THE MOMENT CAME TO RELEASE THE DRT THE PHYSICIAN HAD TO USE EXCESSIVE FORCE. AT FIRST THE NITINOL WIRE WAS STUCK. THE NOSE CONE AND PROXIMAL PART OF THE GRAFT SEEMED TO BE MOVING!! WE THEN DEPLOYED THE IPSI LATERAL LEG SOME MORE (MAYBE THIS WAS CAUSING EXTRA TENSION) AFTER THAT, WE TRIED AGAIN TO REMOVE THE DRT NITINOL AND WE EVENTUALLY SUCCEEDED BUT REALLY WITH EXCESSIVE FORCE. THE PHYSICIAN NEVER EXPERIENCED THIS BEFORE." PATIENT PUTCOME: "GOOD OUTCOME, NO MIGRATION, NO ENDOLEAK."
"THE SAND COLOURED BLOCK ATTACHED TO THE NITINOL WIRE WASN'T ATTACHED TO THE DELIVERY SYSTEM. THE BLOCK WAS FLOATING THE LEFT LATERAL MARKER WAS ON THE RIGHT SIDE DURING INITIAL X-RAY THE NITINOL DRT WIRE WAS STUCK TO THE NOSE CONE. WE LEFT THE SAND COLOURED BLOCK HANGING BESIDES THE DELIVERY SYSTEM, NO ISSUES WE CHECKED THE ANTERIOR AND POSTERIOR MARKERS AND PLACED THE DEVICE, BASED ON THIS, THE LEFT LATERAL MARKER MOVED TO THE LEFT DURING/AFTER DEPLOYMENT WHEN THE MOMENT CAME TO RELEASE THE DRT THE PHYSICIAN HAD TO USE EXCESSIVE FORCE. AT FIRST THE NITINOL WIRE WAS STUCK. THE NOSE CONE AND PROXIMAL PART OF THE GRAFT SEEMED TO BE MOVING!! WE THEN DEPLOYED THE IPSI LATERAL LEG SOME MORE (MAYBE THIS WAS CAUSING EXTRA TENSION) AFTER THAT, WE TRIED AGAIN TO REMOVE THE DRT NITINOL AND WE EVENTUALLY SUCCEEDED BUT REALLY WITH EXCESSIVE FORCE. THE PHYSICIAN NEVER EXPERIENCED THIS BEFORE." PATIENT PUTCOME: "GOOD OUTCOME, NO MIGRATION, NO ENDOLEAK."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 986647 | CUSTOM-MADE TREO ABDOMINAL STENT-GRAFT SYSTEM | STENT, ENDOVASCULAR GRAFT, AORTIC | MIH | BOLTON MEDICAL, INC. | 2411180131 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Male | Other |