TREO ABDOMINAL STENT-GRAFT SYSTEM
Report
- Report Number
- 2247858-2024-00337
- Event Type
- Death
- Date Received
- December 26, 2024
- Date of Event
- December 2, 2024
- Report Date
- June 27, 2025
- Manufacturer
- BOLTON MEDICAL, INC.
- Product Code
- MIH
- PMA / PMN Number
- P190015
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- 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.
"IN THE CLINICIAN'S OPINION WHAT WAS THE CAUSE OF THIS EVENT: IS THIS EVENT RELATED TO A DEVICE FAILURE? YES, IS THIS EVENT RELATED TO THE PROCEDURE? POSSIBLE IS THIS EVENT RELATED TO A PRE-EXISTING CONDITION? POSSIBLY WAS SURGICAL INTERVENTION REQUIRED? NO NOSE CONE BREAK AFTER INTRODUCTION, INTEGRITY OF THE NOSE CONE WAS PROBABLY COMPROMISED DURING MANUFACTURING. THIS WAS AN ACUTE PATIENT WITH A RUPTURE EXTENDING VENTRALLY. THE PATIENT HAD A HIGHLY ANGULATED SHORT INFRARENAL NECK ANGLED DORSALLY. THE TRAJECTORY WAS SO ANGLED THAT THEY HAD TO USE MULTIPLE STIFF GUIDEWIRES. EVENTUALLY, THEY WERE ABLE TO ADVANCE A STIFF BACKUP MEIER WIRE WITH A PROXIMAL BEND IN THE WIRE. WHILE ADVANCING THE MAIN BODY THROUGH THE INFRARENAL NECK, THE PHYSICIAN FELT A SNAPPING SENSATION. IMAGING ALSO SHOWED SOME DAMAGE OF THE NOSE CONE. DEPLOYMENT OF THE MAIN BODY PROCEEDED WITHOUT ANY ISSUES. AFTER PLACING THE MAIN BODY, THE PHYSICIANS WERE VERY SATISFIED WITH THE PROXIMAL SEALING. UPON RETRACTING THE DELIVERY SYSTEM OF THE MAIN BODY, THEY NOTICED THAT THE NOSE CONE WAS NO LONGER ATTACHED TO THE DELIVERY SYSTEM. USING A BALLOON, THEY WERE ABLE TO POSITION THE NOSE CONE THROUGH THE MAIN BODY INTO THE ANEURYSM. SUBSEQUENTLY, THEY MANAGED TO EXTEND STENTS TOWARDS THE ILIAC VESSELS. AFTER BEING STABLE FOR 2.5 DAYS, THE PATIENT DETERIORATED AGAIN AND HAD TO UNDERGO AN OPEN PROCEDURE IN THE OR. THE PROXIMAL SEALING OF THE STENT WAS STILL INTACT. DISTALLY ON THE RIGHT SIDE, HOWEVER, THERE WAS A LARGE ENDOLEAK (TYPE 1B). A CLAMP WAS PLACED ON THE MAIN BODY, AND THE LEG WAS REMOVED FROM THE BODY. THE PHYSICIAN ENCOUNTERED NO RESISTANCE DURING THIS PROCESS. THE RIGHT INTERNAL ILIAC ARTERY WAS THEN SUTURED CLOSED, AND A TUBE GRAFT WAS PLACED BETWEEN THE MAIN BODY AND THE RIGHT EXTERNAL ILIAC ARTERY. AFTER RELEASING THE CLAMP, THE PATIENT BECAME SO UNSTABLE THAT, UNFORTUNATELY, HE PASSED AWAY. THE PHYSICIANS THEMSELVES INDICATED THAT THEY CONSIDERED THIS PROCEDURE TO BE OUTSIDE THE IFU DUE TO ALL THE ANGULATIONS. THE NOSE CONE WAS LEFT BEHIND IN THE PATIENT AFTER THE FIRST PROCEDURE. HOWEVER, THIS DID NOT CAUSE THE PATIENT'S DEATH; IT WAS ULTIMATELY THE TYPE 1B ENDOLEAK THAT LED TO THE FATAL OUTCOME." PATIENT OUTCOME: "NO DIRECT CONSEQUENCES FOR THE PATIENT DUE TO THE BROKEN-OFF NOSE CONE, WHICH THIS EVENT CONCERNS. UNFORTUNATELY, THE PATIENT DID PASS AWAY DUE TO A LARGE TYPE 1B ENDOLEAK".
"IN THE CLINICIAN'S OPINION WHAT WAS THE CAUSE OF THIS EVENT: IS THIS EVENT RELATED TO A DEVICE FAILURE? YES. IS THIS EVENT RELATED TO THE PROCEDURE? POSSIBLE. IS THIS EVENT RELATED TO A PRE-EXISTING CONDITION? POSSIBLY. WAS SURGICAL INTERVENTION REQUIRED? NO. NOSE CONE BREAK AFTER INTRODUCTION, INTEGRITY OF THE NOSE CONE WAS PROBABLY COMPROMISED DURING MANUFACTURING. THIS WAS AN ACUTE PATIENT WITH A RUPTURE EXTENDING VENTRALLY. THE PATIENT HAD A HIGHLY ANGULATED SHORT INFRARENAL NECK ANGLED DORSALLY. THE TRAJECTORY WAS SO ANGLED THAT THEY HAD TO USE MULTIPLE STIFF GUIDEWIRES. EVENTUALLY, THEY WERE ABLE TO ADVANCE A STIFF BACKUP MEIER WIRE WITH A PROXIMAL BEND IN THE WIRE. WHILE ADVANCING THE MAIN BODY THROUGH THE INFRARENAL NECK, THE PHYSICIAN FELT A SNAPPING SENSATION. IMAGING ALSO SHOWED SOME DAMAGE OF THE NOSE CONE. DEPLOYMENT OF THE MAIN BODY PROCEEDED WITHOUT ANY ISSUES. AFTER PLACING THE MAIN BODY, THE PHYSICIANS WERE VERY SATISFIED WITH THE PROXIMAL SEALING. UPON RETRACTING THE DELIVERY SYSTEM OF THE MAIN BODY, THEY NOTICED THAT THE NOSE CONE WAS NO LONGER ATTACHED TO THE DELIVERY SYSTEM. USING A BALLOON, THEY WERE ABLE TO POSITION THE NOSE CONE THROUGH THE MAIN BODY INTO THE ANEURYSM. SUBSEQUENTLY, THEY MANAGED TO EXTEND STENTS TOWARDS THE ILIAC VESSELS. AFTER BEING STABLE FOR 2.5 DAYS, THE PATIENT DETERIORATED AGAIN AND HAD TO UNDERGO AN OPEN PROCEDURE IN THE OR. THE PROXIMAL SEALING OF THE STENT WAS STILL INTACT. DISTALLY ON THE RIGHT SIDE, HOWEVER, THERE WAS A LARGE ENDOLEAK (TYPE 1B). A CLAMP WAS PLACED ON THE MAIN BODY, AND THE LEG WAS REMOVED FROM THE BODY. THE PHYSICIAN ENCOUNTERED NO RESISTANCE DURING THIS PROCESS. THE RIGHT INTERNAL ILIAC ARTERY WAS THEN SUTURED CLOSED, AND A TUBE GRAFT WAS PLACED BETWEEN THE MAIN BODY AND THE RIGHT EXTERNAL ILIAC ARTERY. AFTER RELEASING THE CLAMP, THE PATIENT BECAME SO UNSTABLE THAT, UNFORTUNATELY, HE PASSED AWAY. THE PHYSICIANS THEMSELVES INDICATED THAT THEY CONSIDERED THIS PROCEDURE TO BE OUTSIDE THE IFU DUE TO ALL THE ANGULATIONS. THE NOSE CONE WAS LEFT BEHIND IN THE PATIENT AFTER THE FIRST PROCEDURE. HOWEVER, THIS DID NOT CAUSE THE PATIENT'S DEATH; IT WAS ULTIMATELY THE TYPE 1B ENDOLEAK THAT LED TO THE FATAL OUTCOME." PATIENT OUTCOME: "NO DIRECT CONSEQUENCES FOR THE PATIENT DUE TO THE BROKEN-OFF NOSE CONE, WHICH THIS EVENT CONCERNS. UNFORTUNATELY, THE PATIENT DID PASS AWAY DUE TO A LARGE TYPE 1B ENDOLEAK."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2626781 | TREO ABDOMINAL STENT-GRAFT SYSTEM | STENT, ENDOVASCULAR GRAFT, AORTIC | MIH | BOLTON MEDICAL, INC. | B240506110 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Male | Death| R| O |