FDA Adverse Event
Injury
Summary report: N
GORE TAG THORACIC ENDOPROSTHESIS
MDR report key: 1081680
·
Received July 24, 2008
Report
- Report Number
- 2017233-2008-00399
- Event Type
- Injury
- Date Received
- July 24, 2008
- Date of Event
- June 10, 2008
- Report Date
- July 23, 2008
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- MIH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
A REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS.
Description of Event or Problem · 1
AS REPORTED, IN 2008, THIS PT WAS IMPLANTED WITH GORE TAG THORACIC ENDOPROSTHESIS. ON TWO DAYS LATER, A COMPUTED TOMOGRAPHY SCAN REVEALED THAT THE MOST DISTAL DEVICE HAD INFOLDED. THE SAME DAY, A PALMAZ BALLOON-EXPANDABLE STENT WAS IMPLANTED AND THE INFOLDED DEVICE WAS SUCCESSFULLY REPAIRED. THE PT TOLERATED THE PROCEDURE. FURTHER INVESTIGATION IS BEING CONDUCTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GORE TAG THORACIC ENDOPROSTHESIS | NONE | MIH | W.L. GORE & ASSOCIATES | WLG326 | 04901039 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 28 YR | Required Intervention |