TREO ABDOMINAL STENT-GRAFT SYSTEM
Report
- Report Number
- 2247858-2024-00286
- Event Type
- Injury
- Date Received
- November 18, 2024
- Date of Event
- October 25, 2024
- Report Date
- January 13, 2025
- Manufacturer
- BOLTON MEDICAL, INC.
- Product Code
- MIH
- PMA / PMN Number
- P190015
- 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.
"TYPE 1A ENDOLEAK DUE TO TIGHT CURVATURE OF THE NECK OF THE ANEURYSM: EVAR WAS PERFORMED AS PER NORMAL PROCEDURE. ALTHOUGH IT WAS UNCLEAR WHETHER THE DELIVERY SYSTEM WOULD BE ABLE TO REACH THE TARGET SITE, THE DELIVERY SYSTEM OF THE MAIN BIFURCATED STENT-GRAFT WAS SUCCESSFULLY DELIVERED FROM THE RIGHT LEG OVER A GUIDEWIRE (EGOIST ULTIMATE, MEDICO'S HIRATA). WHEN THE DELIVERY SYSTEM REACHED THE TARGET SITE, ANGIOGRAPHY REVEALED AN ACCORDION-SHAPED NECK OF THE ANEURYSM. THE STENT-GRAFT BEGAN TO BE DEPLOYED FROM JUST BELOW THE RENAL ARTERY AND WAS DEPLOYED TO THE CONTRALATERAL GATE. THE SUPRARENAL STENT WAS RELEASED AND BOTH CONTRALATERAL AND IPSILATERAL LEG EXTENSION STENT GRAFTS (EXCLUDER, GORE) WERE IMPLANTED, AND THE EVAR WAS COMPLETED. AFTER BALLOON MODELING WAS PERFORMED, FINAL ANGIOGRAPHY REVEALED TYPE 1A ENDOLEAK DUE TO INSUFFICIENT APPOSITION OF THE STENT-GRAFT TO THE CURVATURE OF THE NECK OF THE ANEURYSM. ADDITIONAL BALLOON MODELING WAS PERFORMED, BUT ANGIOGRAPHY STILL REVEALED A RESIDUAL ENDOLEAK. HOWEVER, THE INITIAL TREATMENT GOAL OF TREATING THE LUMBAR ANEURYSM WAS ACHIEVED, SO THE PHYSICIAN COMPLETED THE PROCEDURE. PHYSICIAN'S COMMENT: THE PROCEDURE WAS INITIALLY PLANNED TO USE AN EXCLUDER STENT-GRAFT. HOWEVER, THE PHYSICIAN BELIEVES THAT THE OUTCOME WOULD HAVE BEEN THE SAME EVEN WITH THE EXCLUDER STENT-GRAFT. AN ENDURANT STENT-GRAFT MAY HAVE BEEN OPTIMAL IN THIS CASE. OPERATION TYPE: EVAR BLOOD LOSS: THE AMOUNT WAS SMALL. NO IMAGE AVAILABLE DUE TO HOSPITAL POLICY NO PRE-CASE PLAN AVAILABLE: SCHEMA ATTACHED ADDITIONAL INFORMATION WILL BE OBTAINED UPON REQUEST DELIVERY SYSTEM WAS DISCARDED BY THE USER ANCILLARY DEVICES USED: EXCLUDER LEG 121400J, GORE EXCLUDER LEG 121400J, GORE. (TC# (B)(4). PATIENT OUTCOME: "NO HARM TO THE PATIENT'S HEALTH."
"TYPE 1A ENDOLEAK DUE TO TIGHT CURVATURE OF THE NECK OF THE ANEURYSM: EVAR WAS PERFORMED AS PER NORMAL PROCEDURE. ALTHOUGH IT WAS UNCLEAR WHETHER THE DELIVERY SYSTEM WOULD BE ABLE TO REACH THE TARGET SITE, THE DELIVERY SYSTEM OF THE MAIN BIFURCATED STENT-GRAFT WAS SUCCESSFULLY DELIVERED FROM THE RIGHT LEG OVER A GUIDEWIRE (EGOIST ULTIMATE, MEDICO'S HIRATA). WHEN THE DELIVERY SYSTEM REACHED THE TARGET SITE, ANGIOGRAPHY REVEALED AN ACCORDION-SHAPED NECK OF THE ANEURYSM. THE STENT-GRAFT BEGAN TO BE DEPLOYED FROM JUST BELOW THE RENAL ARTERY AND WAS DEPLOYED TO THE CONTRALATERAL GATE. THE SUPRARENAL STENT WAS RELEASED AND BOTH CONTRALATERAL AND IPSILATERAL LEG EXTENSION STENT GRAFTS (EXCLUDER, GORE) WERE IMPLANTED, AND THE EVAR WAS COMPLETED. AFTER BALLOON MODELING WAS PERFORMED, FINAL ANGIOGRAPHY REVEALED TYPE 1A ENDOLEAK DUE TO INSUFFICIENT APPOSITION OF THE STENT-GRAFT TO THE CURVATURE OF THE NECK OF THE ANEURYSM. ADDITIONAL BALLOON MODELING WAS PERFORMED, BUT ANGIOGRAPHY STILL REVEALED A RESIDUAL ENDOLEAK. HOWEVER, THE INITIAL TREATMENT GOAL OF TREATING THE LUMBAR ANEURYSM WAS ACHIEVED, SO THE PHYSICIAN COMPLETED THE PROCEDURE. PHYSICIAN'S COMMENT: THE PROCEDURE WAS INITIALLY PLANNED TO USE AN EXCLUDER STENT-GRAFT. HOWEVER, THE PHYSICIAN BELIEVES THAT THE OUTCOME WOULD HAVE BEEN THE SAME EVEN WITH THE EXCLUDER STENT-GRAFT. AN ENDURANT STENT-GRAFT MAY HAVE BEEN OPTIMAL IN THIS CASE. OPERATION TYPE: EVAR BLOOD LOSS: THE AMOUNT WAS SMALL. NO IMAGE AVAILABLE DUE TO HOSPITAL POLICY NO PRE-CASE PLAN AVAILABLE: SCHEMA ATTACHED ADDITIONAL INFORMATION WILL BE OBTAINED UPON REQUEST DELIVERY SYSTEM WAS DISCARDED BY THE USER ANCILLARY DEVICES USED: EXCLUDER LEG 121400J, GORE EXCLUDER LEG 121400J, GORE (TC#BM 241002564)" PATIENT OUTCOME: "NO HARM TO THE PATIENT'S HEALTH."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2608675 | TREO ABDOMINAL STENT-GRAFT SYSTEM | STENT, ENDOVASCULAR GRAFT, AORTIC | MIH | BOLTON MEDICAL, INC. | 2306150045 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |