CUSTOM-MADE TREO ABDOMINAL STENT-GRAFT SYSTEM
Report
- Report Number
- 2247858-2025-00031
- Event Type
- Injury
- Date Received
- February 12, 2025
- Date of Event
- January 21, 2025
- Report Date
- May 2, 2025
- Manufacturer
- BOLTON MEDICAL, INC.
- Product Code
- MIH
- PMA / PMN Number
- P190015
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SN
- 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 SINGAPORE. 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 SINGAPORE. 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 ALIGNMENT OF THE MARKERS ON THE FENESTRATION OF THE FEN LEG SEEM TO BE DISTORTED DURING LOADING INSIDE THE DELIVERY SYSTEM, MAKING THE DEPLOYMENT WITH FINAL ORIENTATION OF THE FENESTRATION WAS DEVIATED FROM ITS ORIGINAL PLANNED ORIENTATION. 1. PATIENT WAS IMPLANTED WITH 4 FEN TREO MAIN BODY WITH ALL THE BRIDGING STENTS WERE DEPLOYED. 2. THE ANGIOGRAM WAS PERFORMED TO SHOW THE LEFT ILIAC BIFURCATION UNDER CAUDAL ADJUSTMENT (SEE IMAGE). 3. THE FEN LEG DEVICE WAS SCREENED UNDER FLUOROSCOPY BUT THE MARKERS OF 3 & 9 O'CLOCK CANNOT BE SUPERIMPOSED AND ALIGNED AS THE 3 STRAIGHT DOTS WITH 12 & 6 O'CLOCK MARKERS UNDER ROTATION OF DIFFERENT ORIENTATION (SEE IMAGE). 4. FINALLY, THE 12 O'CLOCK MARKER WAS TAKEN AS THE ONLY REFERENCE POINT TO ALIGN TO THE PATIENT'S LATERAL RIGHT SIDE DURING THE DEVICE WAS BEING INSERTED FROM THE PATIENT LEFT SIDE. 5. DURING THE DEPLOYMENT, THE 12 O'CLOCK MARKER SEEM ROTATED TO PATIENT ANTERIOR SURFACE. UPON FULL DEPLOYMENT, THE FENESTRATION ORIENTATION BECOME RIGHT SIDE ANTERIOR RATHER THAN THE RIGHT LATERAL AS PLANNED. (SEE IMAGE) 6. ANGIOGRAM WAS PERFORMED AND THERE WAS DISAPPEARING OF THE PATIENT ORIGINAL LEFT INTERNAL ILIAC ARTERY. 7. PROF. (B)(6) INSERTED 10MM X20MM PTA BALLOON TO INFLATE JUST BELOW THE FENESTRATION AND TRY TO ROTATE THE BALLOON TO MAKE THE FENESTRATION CHANGE TO RIGHT LATERAL BUT UNSUCCESSFUL (SEE IMAGE) 8. CANNULATION PERFORMED BY THE RADIOLOGIST WITH SELECTIVE CATHETER AND 0.035" FLOPPY GUIDE WIRE BUT THERE WAS THE FAILURE OF CANNULATION BY SEVERAL ATTEMPTS. 9. THE SURGEON DID THE FINAL ANGIOGRAM AND THE LIIA WAS LOST. FINALLY THE SURGEON PERFORMED THE PERCUTANEOUS CLOSURE OF THE GROIN. IS THIS EVENT RELATED TO A DEVICE FAILURE / DEFICIENCY? POSSIBLY IS THIS EVENT RELATED TO THE PROCEDURE? YES IS THIS EVENT RELATED TO A PRE-EXISTING CONDITION? POSSIBLY WAS SURGICAL INTERVENTION REQUIRED? NO" PATIENT OUTCOME: "THE PATIENT LOST THE LEFT INTERNAL ILIAC ARTERY FLOW BY RADIOLOGICALLY. THERE WAS NOT ANY ADVERSE CLINICAL CONSEQUENCE OF THE PATIENT UP TO NOW."
"THE ALIGNMENT OF THE MARKERS ON THE FENESTRATION OF THE FEN LEG SEEM TO BE DISTORTED DURING LOADING INSIDE THE DELIVERY SYSTEM, MAKING THE DEPLOYMENT WITH FINAL ORIENTATION OF THE FENESTRATION WAS DEVIATED FROM ITS ORIGINAL PLANNED ORIENTATION. 1. PATIENT WAS IMPLANTED WITH 4 FEN TREO MAIN BODY WITH ALL THE BRIDGING STENTS WERE DEPLOYED. 2. THE ANGIOGRAM WAS PERFORMED TO SHOW THE LEFT ILIAC BIFURCATION UNDER CAUDAL ADJUSTMENT (SEE IMAGE) 3. THE FEN LEG DEVICE WAS SCREENED UNDER FLUOROSCOPY BUT THE MARKERS OF 3 & 9 O'CLOCK CANNOT BE SUPERIMPOSED AND ALIGNED AS THE 3 STRAIGHT DOTS WITH 12 & 6 O'CLOCK MARKERS UNDER ROTATION OF DIFFERENT ORIENTATION (SEE IMAGE) 4. FINALLY, THE 12 O'CLOCK MARKER WAS TAKEN AS THE ONLY REFERENCE POINT TO ALIGN TO THE PATIENT'S LATERAL RIGHT SIDE DURING THE DEVICE WAS BEING INSERTED FROM THE PATIENT LEFT SIDE 5. DURING THE DEPLOYMENT, THE 12 O'CLOCK MARKER SEEM ROTATED TO PATIENT ANTERIOR SURFACE. UPON FULL DEPLOYMENT, THE FENESTRATION ORIENTATION BECOME RIGHT SIDE ANTERIOR RATHER THAN THE RIGHT LATERAL AS PLANNED. (SEE IMAGE) 6. ANGIOGRAM WAS PERFORMED AND THERE WAS DISAPPEARING OF THE PATIENT ORIGINAL LEFT INTERNAL ILIAC ARTERY. 7. PROF. GLENN TAN INSERTED 10MM X20MM PTA BALLOON TO INFLATE JUST BELOW THE FENESTRATION AND TRY TO ROTATE THE BALLOON TO MAKE THE FENESTRATION CHANGE TO RIGHT LATERAL BUT UNSUCCESSFUL (SEE IMAGE) 8. CANNULATION PERFORMED BY THE RADIOLOGIST WITH SELECTIVE CATHETER AND 0.035" FLOPPY GUIDE WIRE BUT THERE WAS THE FAILURE OF CANNULATION BY SEVERAL ATTEMPTS. 9. THE SURGEON DID THE FINAL ANGIOGRAM AND THE LIIA WAS LOST. FINALLY, THE SURGEON PERFORMED THE PERCUTANEOUS CLOSURE OF THE GROIN. IS THIS EVENT RELATED TO A DEVICE FAILURE / DEFICIENCY? POSSIBLY. IS THIS EVENT RELATED TO THE PROCEDURE? YES. IS THIS EVENT RELATED TO A PRE-EXISTING CONDITION? POSSIBLY. WAS SURGICAL INTERVENTION REQUIRED? NO". PATIENT OUTCOME: "THE PATIENT LOST THE LEFT INTERNAL ILIAC ARTERY FLOW BY RADIOLOGICALLY. THERE WAS NOT ANY ADVERSE CLINICAL CONSEQUENCE OF THE PATIENT UP TO NOW."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 904098 | CUSTOM-MADE TREO ABDOMINAL STENT-GRAFT SYSTEM | STENT, ENDOVASCULAR GRAFT, AORTIC | MIH | BOLTON MEDICAL, INC. | 2411120307 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Male | Other| S |