GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM
Report
- Report Number
- 2017233-2022-02834
- Event Type
- Injury
- Date Received
- March 29, 2022
- Date of Event
- March 3, 2022
- Report Date
- June 27, 2022
- Manufacturer
- W. L. GORE & ASSOCIATES, INC.
- Product Code
- MIH
- PMA / PMN Number
- P040043
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
(B)(4).
ADDED G3/G4, H1/H2, H6: ATTACHED LITERATURE ARTICLE: "OPEN TACKING OF A MIGRATED THORACIC ENDOVASCULAR AORTIC GRAFT"; JOHN M. TRAHANAS, CHRISTOPHER J. KWOLEK, AND GEORGE TOLIS, ANN VASC SURG 2020; 63: 461.E7¿461.E9.
THE FOLLOWING ARTICLE WAS REVIEWED. OPEN TACKING OF A MIGRATED THORACIC ENDOVASCULAR AORTIC GRAFTS, JOHN TRAHANAS ET AL, ANNALS OF VASCULAR SURGERY. 2020. BACKGROUND: COMPLICATIONS OF THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR) ARE BEGINNING TO EMERGE AS NOVEL VASCULAR ISSUES. WHILE ENDOVASCULAR SOLUTIONS EXIST FOR MOST, SOME GRAFT COMPLICATIONS REQUIRE A MORE TRADITIONAL OPEN SOLUTION. THESE OPERATIONS ARE MOST COMMONLY PERFORMED FOR ENDOLEAK OR DISEASE PROGRESSION. MUCH LESS FREQUENTLY OBSERVED IS THE MIGRATION OF THE ENDOGRAFT REQUIRING OPEN REINTERVENTION. HEREIN WE PRESENT A CASE OF A PROXIMALLY MIGRATED TEVAR GRAFT, WHICH REQUIRED OPEN FIXATION UNDER DEEP HYPOTHERMIC CIRCULATORY ARREST (DHCA).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2901401 | GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | W. L. GORE & ASSOCIATES, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Female | Required Intervention |