FDA Adverse Event
Injury
Summary report: N
GORE TAG THORACIC ENDOPROSTHESIS
MDR report key: 1140236
·
Received August 29, 2008
Report
- Report Number
- 2017233-2008-00537
- Event Type
- Injury
- Date Received
- August 29, 2008
- Date of Event
- May 15, 2008
- Report Date
- August 27, 2008
- Manufacturer
- W.L. GORE & ASSOCIATES, INC
- Product Code
- MIH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
A REVIEW OF THE MANUFACTURING PAPERWORK IS BEING CONDUCTED.
Description of Event or Problem · 1
AS REPORTED, IN 2008, THIS PATIENT WAS IMPLANTED WITH A GORE TAG THORACIC ENDOPROSTHESIS. THREE DAYS LATER, A REINTERVENTION WAS PERFORMED DUE TO A TYPE 1 ENDOLEAK. AN ADDITIONAL DEVICE WAS IMPLANTED. THE PATIENT IS DOING FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GORE TAG THORACIC ENDOPROSTHESIS | ENDOVASCULAR GRAFT SYSTEM | MIH | W.L. GORE & ASSOCIATES, INC | WLG326 | 05889976 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Required Intervention |