TREO ABDOMINAL STENT-GRAFT SYSTEM
Report
- Report Number
- 2247858-2023-00094
- Event Type
- Malfunction
- Date Received
- April 13, 2023
- Date of Event
- March 8, 2023
- Report Date
- August 17, 2023
- Manufacturer
- BOLTON MEDICAL, INC.
- Product Code
- MIH
- PMA / PMN Number
- P190015
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TH
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
BOLTON MEDICAL IS VOLUNTARILY REPORTING AN EVENT RELATED TO A TREO AUI OCCLUDER DEVICE. THE TREO AUI OCCLUDER DEVICES ARE NOT MARKETED IN THE US, HOWEVER THE DELIVERY SYSTEM IS SIMILAR TO THE TREO ABDOMINAL STENT GRAFT SYSTEM APPROVED FOR SALE IN THE US (P190015). THE EVENT OCCURRED IN THAILAND. 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 AUI OCCLUDER DEVICE. THE TREO AUI OCCLUDER DEVICES ARE NOT MARKETED IN THE US, HOWEVER THE DELIVERY SYSTEM IS SIMILAR TO THE TREO ABDOMINAL STENT GRAFT SYSTEM APPROVED FOR SALE IN THE US (P190015). THE EVENT OCCURRED IN THAILAND.
TREO ABDOMINAL STENT-GRAFT SYSTEM (28-A1-36-100S) LOT: B221118055; PLANED EVAR: AUI + LEG DURING CONTINUING TO REMOVAL OF AUI STENT-GRAFT DELIVERY SYSTEM WITH LEAVING INTRODUCER SHEATH BEHIND. THE TIP IS BROKEN AND SEPARATE FROM THE DELIVERY SYSTEM AS THE PHOTO OF FLUOROSCOPE AS IN ATTACH. SO, THE SURGEON DESIRED TO USE SNARE TO REMOVE "BROKEN TIP" FROM PATIENT'S VESSEL. THE COMPLAINT'S DEVICE IS WAITING TO RETURN TO QUALITY CONTROL TEAM OF TERUMO AORTIC TO INVESTIGATING. PATIENT OUTCOME - "THE PATIENT STILL SAFE. HOWEVER, THE PER CUTANEOUS WAS CHANGED TO CUTDOWN."
TREO ABDOMINAL STENT-GRAFT SYSTEM (28-A1-36-100S) LOT: B221118055; PLANED EVAR: AUI + LEG DURING CONTINUING TO REMOVAL OF AUI STENT-GRAFT DELIVERY SYSTEM WITH LEAVING INTRODUCER SHEATH BEHIND. THE TIP IS BROKEN AND SEPARATE FROM THE DELIVERY SYSTEM AS THE PHOTO OF FLUOROSCOPE AS IN ATTACH. SO, THE SURGEON DESIRED TO USE SNARE TO REMOVE "BROKEN TIP" FROM PATIENT'S VESSEL. THE COMPLAINT'S DEVICE IS WAITING TO RETURN TO QUALITY CONTROL TEAM OF TERUMO AORTIC TO INVESTIGATING. PATIENT OUTCOME: "THE PATIENT STILL SAFE. HOWEVER, THE PER CUTANEOUS WAS CHANGED TO CUTDOWN."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 991953 | TREO ABDOMINAL STENT-GRAFT SYSTEM | STENT, ENDOVASCULAR GRAFT, AORTIC | MIH | BOLTON MEDICAL, INC. | B221118055 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Male | Required Intervention |