TREO ABDOMINAL STENT-GRAFT SYSTEM
Report
- Report Number
- 2247858-2023-00204
- Event Type
- Malfunction
- Date Received
- August 7, 2023
- Date of Event
- July 16, 2023
- Report Date
- September 30, 2023
- Manufacturer
- BOLTON MEDICAL, INC.
- Product Code
- MIH
- PMA / PMN Number
- P190015
- Product Problem
- 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.
"DELIVERY SYSTEM TIP BROKEN/ THROMBUS: COILING OF THE RIGHT IIA WAS PERFORMED VIA AN IPSILATERAL APPROACH. AN EGOSIT GUIDEWIRE (MEDICOS HIRATA) WAS INSERTED FROM THE RIGHT FA, AND A DRYSEAL SHEATH (14FR, GORE) WAS INSERTED. ANGIOGRAPHY WAS PERFORMED USING A PIGTAIL-SHAPED ANGIOGRAPHIC CATHETER. THE MAIN BIFURCATED STENT GRAFT (28-B2-28-100U) WAS INSERTED FROM THE RIGHT FA AND DEPLOYED TILL THE CONTRALATERAL GATE WAS RELEASED, AND THE BARE STENT WAS DEPLOYED. AFTER CANNULATION OF THE CONTRALATERAL GATE OF THE MAIN BIFURCATED STENT GRAFT, A CONTRALATERAL LEG EXTENSION STENT GRAFT (28-L2-13-160U) WAS IMPLANTED UP TO THE EIA. THE MAIN BIFURCATED STENT GRAFT WAS THEN COMPLETELY DEPLOYED. THE ENTIRE DELIVERY SYSTEM WAS WITHDRAWN AND A DRYSEAL SHEATH (16FR, GORE) WAS INSERTED. THE IPSILATERAL LENGTH WAS MEASURED, AND A LENGTH OF 100MM WAS FOUND TO BE REQUIRED. AN IPSILATERAL LEG EXTENSION STENT GRAFT (28-L2-24-100U) WAS SELECTED AND IMPLANTED. A TOUCH UP WAS PERFORMED WITH A RELIANT BALLOON CATHETER (MEDTRONIC). ANGIOGRAPHY SHOWED AN ENDOLEAK LIKE TYPE 2 AND ANOTHER TOUCH-UP WAS PERFORMED ON THE LEFT LEG ONLY. ON JULY 16, X-RAY SHOWED A RESIDUE IN THE MAIN BIFURCATED STENT GRAFT. CT WAS ALSO PERFORMED, AND IT WAS DETERMINED THAT RETRIEVAL WAS NECESSARY. BOTH OF THE FA WERE PUNCTURED, AND A DRYSEAL SHEATH (18FR, GORE) WAS INSERTED. THE RESIDUE WAS ATTEMPTED TO RETRIEVE WITH AN INDY SNARE (COOK MEDICAL). WHEN THE ATTEMPT WAS FAILED, THE RESIDUE IN THE MAIN BIFURCATED STENT GRAFT MOVED INTO THE DESCENDING AORTA. THE SNARE SOMEHOW CAUGHT THE RESIDUE, AND THE RESIDUE WAS WITHDRAWN HOLDING WITH THE TIP OF THE DRYSEAL. THE RESIDUE WAS VISUALLY INSPECTED OUTSIDE THE BODY AND DETERMINED TO BE THE TIP OF THE DELIVERY SYSTEM OF THE TREO MAIN BIFURCATED STENT GRAFT. AS THE PERIPHERAL FLOW WAS SLIGHTLY IMPAIRED BY A THROMBUS, THE THROMBUS WAS ALSO REMOVED AT THE SAME TIME. THE PUNCTURE SITES WERE SUTURED, AND THE PATIENT WAS RETURNED TO THE WARD. PHYSICIAN'S COMMENTS: WHEN THE DELIVERY SYSTEM WAS REMOVED, IT WAS OBSERVED UNDER FLUOROSCOPY UNTIL THE TIP OF THE DELIVERY SYSTEM WAS ENTERED INTO THE IMPLANTED MAIN BIFURCATED STENT GRAFT. THEREAFTER, THE DELIVERY SYSTEM WAS WITHDRAWN WITHOUT FLUOROSCOPIC OBSERVATION. THE REMOVED DELIVERY SYSTEM WAS NOT CHECKED WHETHER THE TIP WAS DETACHED. NO ABNORMALITIES WERE FOUND ON FLUOROSCOPY. HOWEVER, A REVIEW OF THE IMMEDIATE POSTOPERATIVE X-RAY SHOWED A RESIDUE NEAR THE DESCENDING AORTA AT THE LEVEL OF THE HEART. THERE WERE NO ABNORMALITIES SUCH AS RESISTANCE DURING THE PROCEDURE. - HAVE THERE BEEN SIMILAR CASES BEFORE? - WHAT ARE THE POSSIBLE CAUSES OF THIS EVENT? OPERATION TYPE: EVAR NO BLOOD LOSS IMAGE AVAILABLE PRE-CASE PLAN AVAILABLE ADDITIONAL INFORMATION AVAILABLE ANCILLARY DEVICES: DRYSEAL SHEATH (GORE), INDY SNARE (COOK MEDICAL). (TC#BM230701548)" . PATIENT OUTCOME - "THE PATIENT WAS NOT IN SERIOUS CONDITION AND RECOVERED."
"DELIVERY SYSTEM TIP BROKEN/ THROMBUS: COILING OF THE RIGHT IIA WAS PERFORMED VIA AN IPSILATERAL APPROACH. AN EGOSIT GUIDEWIRE (MEDICOS HIRATA) WAS INSERTED FROM THE RIGHT FA, AND A DRYSEAL SHEATH (14FR, GORE) WAS INSERTED. ANGIOGRAPHY WAS PERFORMED USING A PIGTAIL-SHAPED ANGIOGRAPHIC CATHETER. THE MAIN BIFURCATED STENT GRAFT (28-B2-28-100U) WAS INSERTED FROM THE RIGHT FA AND DEPLOYED TILL THE CONTRALATERAL GATE WAS RELEASED, AND THE BARE STENT WAS DEPLOYED. AFTER CANNULATION OF THE CONTRALATERAL GATE OF THE MAIN BIFURCATED STENT GRAFT, A CONTRALATERAL LEG EXTENSION STENT GRAFT (28-L2-13-160U) WAS IMPLANTED UP TO THE EIA. THE MAIN BIFURCATED STENT GRAFT WAS THEN COMPLETELY DEPLOYED. THE ENTIRE DELIVERY SYSTEM WAS WITHDRAWN AND A DRYSEAL SHEATH (16FR, GORE) WAS INSERTED. THE IPSILATERAL LENGTH WAS MEASURED, AND A LENGTH OF 100MM WAS FOUND TO BE REQUIRED. AN IPSILATERAL LEG EXTENSION STENT GRAFT (28-L2-24-100U) WAS SELECTED AND IMPLANTED. A TOUCH UP WAS PERFORMED WITH A RELIANT BALLOON CATHETER (MEDTRONIC). ANGIOGRAPHY SHOWED AN ENDOLEAK LIKE TYPE 2 AND ANOTHER TOUCH-UP WAS PERFORMED ON THE LEFT LEG ONLY. ON (B)(6) 2023, X-RAY SHOWED A RESIDUE IN THE MAIN BIFURCATED STENT GRAFT. CT WAS ALSO PERFORMED, AND IT WAS DETERMINED THAT RETRIEVAL WAS NECESSARY. BOTH OF THE FA WERE PUNCTURED, AND A DRYSEAL SHEATH (18FR, GORE) WAS INSERTED. THE RESIDUE WAS ATTEMPTED TO RETRIEVE WITH AN INDY SNARE (COOK MEDICAL). WHEN THE ATTEMPT WAS FAILED, THE RESIDUE IN THE MAIN BIFURCATED STENT GRAFT MOVED INTO THE DESCENDING AORTA. THE SNARE SOMEHOW CAUGHT THE RESIDUE, AND THE RESIDUE WAS WITHDRAWN HOLDING WITH THE TIP OF THE DRYSEAL. THE RESIDUE WAS VISUALLY INSPECTED OUTSIDE THE BODY AND DETERMINED TO BE THE TIP OF THE DELIVERY SYSTEM OF THE TREO MAIN BIFURCATED STENT GRAFT. AS THE PERIPHERAL FLOW WAS SLIGHTLY IMPAIRED BY A THROMBUS, THE THROMBUS WAS ALSO REMOVED AT THE SAME TIME. THE PUNCTURE SITES WERE SUTURED, AND THE PATIENT WAS RETURNED TO THE WARD. PHYSICIAN'S COMMENTS: WHEN THE DELIVERY SYSTEM WAS REMOVED, IT WAS OBSERVED UNDER FLUOROSCOPY UNTIL THE TIP OF THE DELIVERY SYSTEM WAS ENTERED INTO THE IMPLANTED MAIN BIFURCATED STENT GRAFT. THEREAFTER, THE DELIVERY SYSTEM WAS WITHDRAWN WITHOUT FLUOROSCOPIC OBSERVATION. THE REMOVED DELIVERY SYSTEM WAS NOT CHECKED WHETHER THE TIP WAS DETACHED. NO ABNORMALITIES WERE FOUND ON FLUOROSCOPY. HOWEVER, A REVIEW OF THE IMMEDIATE POSTOPERATIVE X-RAY SHOWED A RESIDUE NEAR THE DESCENDING AORTA AT THE LEVEL OF THE HEART. THERE WERE NO ABNORMALITIES SUCH AS RESISTANCE DURING THE PROCEDURE. - HAVE THERE BEEN SIMILAR CASES BEFORE? - WHAT ARE THE POSSIBLE CAUSES OF THIS EVENT? OPERATION TYPE: EVAR. NO BLOOD LOSS . IMAGE AVAILABLE. PRE-CASE PLAN AVAILABLE . ADDITIONAL INFORMATION AVAILABLE. ANCILLARY DEVICES: DRYSEAL SHEATH (GORE), INDY SNARE (COOK MEDICAL). (B)(4). PATIENT OUTCOME - "THE PATIENT WAS NOT IN SERIOUS CONDITION AND RECOVERED."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1699339 | TREO ABDOMINAL STENT-GRAFT SYSTEM | STENT, ENDOVASCULAR GRAFT, AORTIC | MIH | BOLTON MEDICAL, INC. | 2208120062 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Male | Required Intervention |