TREO ABDOMINAL STENT-GRAFT SYSTEM
Report
- Report Number
- 2247858-2023-00234
- Event Type
- Injury
- Date Received
- September 6, 2023
- Date of Event
- August 14, 2023
- Report Date
- December 22, 2023
- Manufacturer
- BOLTON MEDICAL, INC.
- Product Code
- MIH
- PMA / PMN Number
- P190015
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- 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.
"PRE-PLANNING OF THE CASE HAD A BIFURCATION MEASURING WITH A 20MM AVERAGE LUMEN A TREO 30X80 MAIN BODY WAS USED FOLLOWED BY A 12X120 LIMB IN THE LEFT COMMON ILIAC AND A 15X120 LIMB IN THE RIGHT. NO FLOW LIMITING FACTORS WERE OBSERVED IN THE CASE, SO THE PATIENT'S GROINS WERE CLOSED TO BE FOLLOWED WITH A LOWER EXTREMITY BYPASS ON THE LEFT LOWER EXTREMITY. ON (B)(6) 2023 DR.(B)(6) APPROACHED ME AND EXPLAINED HE HAD TO OPERATE AND REOPEN THE LIMB ON (B)(6) 2023 THROUGH ENDOVASCULAR APPROACH, FOLLOWED BY BALLOONING AND STENTING OF THE LEFT LIMB TO REOPEN THE LUMEN FOR FLOW TO PROGRESS THROUGH THE LIMB. PREOP PLANNING, OPERATIVE IMAGES, POSTOP IMAGES, AND REINTERVENTION IMAGES ARE AVAILABLE, JUST LET ME KNOW WHERE TO SEND THEM AND HOW TO UPLOAD THEM. " PATIENT OUTCOME - "THE PATIENT HAD TO UNDERGO REINTERVENTION TO REGAIN PATENCY OF THE LEFT LIMB OF THE EVAR PLACED ON (B)(6) 2023. HIS BYPASS HOWEVER DID NOT THROMBOSE."
"PRE-PLANNING OF THE CASE HAD A BIFURCATION MEASURING WITH A 20MM AVERAGE LUMEN A TREO 30X80 MAIN BODY WAS USED FOLLOWED BY A 12X120 LIMB IN THE LEFT COMMON ILIAC AND A 15X120 LIMB IN THE RIGHT. NO FLOW LIMITING FACTORS WERE OBSERVED IN THE CASE, SO THE PATIENT'S GROINS WERE CLOSED TO BE FOLLOWED WITH A LOWER EXTREMITY BYPASS ON THE LEFT LOWER EXTREMITY. ON (B)(6) 2023 DR. (B)(6) APPROACHED ME AND EXPLAINED HE HAD TO OPERATE AND REOPEN THE LIMB ON (B)(6) 2023 THROUGH ENDOVASCULAR APPROACH, FOLLOWED BY BALLOONING AND STENTING OF THE LEFT LIMB TO REOPEN THE LUMEN FOR FLOW TO PROGRESS THROUGH THE LIMB. PREOP PLANNING, OPERATIVE IMAGES, POSTOP IMAGES, AND REINTERVENTION IMAGES ARE AVAILABLE, JUST LET ME KNOW WHERE TO SEND THEM AND HOW TO UPLOAD THEM. " PATIENT OUTCOME - "THE PATIENT HAD TO UNDERGO REINTERVENTION TO REGAIN PATENCY OF THE LEFT LIMB OF THE EVAR PLACED ON (B)(6) 2023. HIS BYPASS HOWEVER DID NOT THROMBOSE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 986608 | TREO ABDOMINAL STENT-GRAFT SYSTEM | STENT, ENDOVASCULAR GRAFT, AORTIC | MIH | BOLTON MEDICAL, INC. | 2105100058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Male | Required Intervention |