FDA Adverse Event
Injury
Summary report: N
GORE TAG THORACIC ENDOPROSTHESIS
MDR report key: 1915618
·
Received December 1, 2010
Report
- Report Number
- 2017233-2010-00536
- Event Type
- Injury
- Date Received
- December 1, 2010
- Date of Event
- November 5, 2010
- Report Date
- December 1, 2010
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- MIH
- PMA / PMN Number
- P040043
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- 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. ADDITIONAL DEVICE USED IN PROCEDURE: (B)(4).
Description of Event or Problem · 1
ON (B)(6), 2010, THIS PT UNDERWENT ENDOVASCULAR REPAIR FOR A THORACIC AORTIC ANEURYSM USING CONFORMABLE GORE TAG THORACIC ENDOPROSTHESES. A CEREBROSPINAL FLUID DRAIN WAS NOT USED DURING THE PROCEDURE. ON DAY 2 POST-OP, THE PT PRESENTED WITH NO FEELING OR MOVEMENT IN THEIR LEGS. ON DAY 7 POST-OP, THE PT HAD REGAINED SOME FEELING IN THEIR LEGS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GORE TAG THORACIC ENDOPROSTHESIS | MIH / SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | W.L. GORE & ASSOCIATES | WLG426 | 8029967 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Other |