FDA Adverse Event
Injury
Summary report: N
GORE TAG THORACIC ENDOPROSTHESIS
MDR report key: 1130457
·
Received August 20, 2008
Report
- Report Number
- 2017233-2008-00495
- Event Type
- Injury
- Date Received
- August 20, 2008
- Date of Event
- July 20, 2008
- Report Date
- August 20, 2008
- Manufacturer
- W.L. GORE & ASSOCIATES, INC
- Product Code
- MIH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- 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 PT PRESENTED WITH TRAUMATIC RUPTURE OF THE AORTA AND WAS TREATED WITH A GORE TAG THORACIC ENDOPROSTHESIS. TWO DAYS POST-PROCEDURE, A CT REVEALED INFOLDING OF THE DEVICE. AT APPROXIMATELY ONE WEEK LATER, A REINTERVENTION OCCURRED WHERE THE PHYSICIAN PERFORMED ADD'L BALLOONING AND THE INFOLDING WAS RESOLVED. PT IS DOING FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GORE TAG THORACIC ENDOPROSTHESIS | NONE | MIH | W.L. GORE & ASSOCIATES, INC | WLG326 | 04478392 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 25 YR | Required Intervention |