FDA Adverse Event
Injury
Summary report: N
GORE TAG THORACIC ENDOPROSTHESIS
MDR report key: 2215058
·
Received August 12, 2011
Report
- Report Number
- 2017233-2011-00417
- Event Type
- Injury
- Date Received
- August 12, 2011
- Date of Event
- October 26, 2007
- Report Date
- August 11, 2011
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- MIH
- PMA / PMN Number
- P040043
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, 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. PLEASE REFER TO MEDWATCH # 2953161-2011-00178 FOR THE MEDWATCH ON THE GORE EXCLUDER AAA ENDOPROSTHESIS ASSOCIATED WITH THIS EVENT.
Description of Event or Problem · 1
ON (B)(6), 2007, THIS PT WAS IMPLANTED WITH A GORE TAG THORACIC ENDOPROSTHESIS AND GORE EXCLUDER AAA ENDOPROSTHESIS AORTIC EXTENDER COMPONENT. ON (B)(6), 2007, AN ADDITIONAL PROCEDURE WAS PERFORMED WHEREBY TWO ADDITIONAL GORE TAG DEVICES AND AN AORTIC EXTENDER COMPONENT WERE IMPLANTED. ADDITIONAL INFO HAS BEEN REQUESTED.
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 | 04447893 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Hospitalization| R |