FDA Adverse Event
Injury
Summary report: N
GORE TAG THORACIC ENDOPROSTHESIS
MDR report key: 2953894
·
Received February 4, 2013
Report
- Report Number
- 2017233-2013-00046
- Event Type
- Injury
- Date Received
- February 4, 2013
- Date of Event
- June 27, 2011
- Report Date
- January 11, 2013
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- MIH
- PMA / PMN Number
- P040043
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. THE ROOT CAUSE OF THE INTERVENTION IS UNKNOWN.
Description of Event or Problem · 1
ON (B)(6) 2010, THE PATIENT WAS IMPLANTED WITH A GORE TAG THORACIC ENDOPROSTHESIS. ON (B)(6) 2011, A PROCEDURE WAS PERFORMED WHEREBY AN ADDITIONAL GORE TAG DEVICE WAS IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 45768 | GORE TAG THORACIC ENDOPROSTHESIS | MIH / SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | W.L. GORE & ASSOCIATES | 7380664 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 32 YR | Hospitalization| R |