FDA Adverse Event
Injury
Summary report: N
GORE TAG THORACIC ENDOPROSTHESIS
MDR report key: 1180090
·
Received September 29, 2008
Report
- Report Number
- 2017233-2008-00671
- Event Type
- Injury
- Date Received
- September 29, 2008
- Date of Event
- September 22, 2008
- Report Date
- September 26, 2008
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- MIH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
A REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. RESULTS: THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. FURTHER INVESTIGATION IS PENDING. IMAGES ARE BEING EVALUATED BY GORE.
Description of Event or Problem · 1
IN 2008, THIS PATIENT WAS IMPLANTED WITH GORE TAG THORACIC ENDOPROSTHESIS IN THE AORTIC ARCH AND DESCENDING THORACIC AORTA. AT AN UNKNOWN DATE, A FOLLOW-UP CT REVEALED INVAGINATION IN THE PROXIMAL DEVICE. TWO MONTHS LATER, A REINTERVENTION OCCURRED WHERE A TALENT DEVICE WAS IMPLANTED INSIDE THE EXCLUDER DEVICE RESOLVING INVAGINATION. THE PATIENT TOLERATED THE PROCEDURE AND IS REPORTED TO BE STABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GORE TAG THORACIC ENDOPROSTHESIS | NONE | MIH | W.L. GORE & ASSOCIATES | WLG326 | 05413021 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Required Intervention |