FDA Adverse Event
Injury
Summary report: N
GORE TAG THORACIC ENDOPROSTHESIS
MDR report key: 1791752
·
Received August 4, 2010
Report
- Report Number
- 2017233-2010-00361
- Event Type
- Injury
- Date Received
- August 4, 2010
- Date of Event
- June 22, 2010
- Report Date
- August 3, 2010
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- MIH
- PMA / PMN Number
- P040043
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL DEVICE: TG3115/(B)(4).
Description of Event or Problem · 1
ON (B)(6) 2007, THE PATIENT WAS TREATED FOR AN ANEURYSM IN THE DESCENDING THORACIC AORTA WITH GORE TAG THORACIC ENDOPROSTHESES. ON APPROXIMATELY (B)(6) 2010, STENT-GRAFT INFOLDING WAS OBSERVED ALONG WITH AN ENDOLEAK AND ANEURYSM ENLARGEMENT. THE PHYSICIAN DID NOT IDENTIFY A CAUSE FOR THE INFOLDING AND ENDOLEAK.
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 | WLG326 | 04125074 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Life Threatening |