FDA Adverse Event
Injury
Summary report: N
GORE TAG THORACIC ENDOPROSTHESIS
MDR report key: 1241725
·
Received November 20, 2008
Report
- Report Number
- 2017233-2008-00889
- Event Type
- Injury
- Date Received
- November 20, 2008
- Date of Event
- October 3, 2008
- Report Date
- November 19, 2008
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- MIH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
A REVIEW OF THE MANUFACTURING RECORDS HAS BEEN CONDUCTED. THE MANUFACTURING RECORDS REVIEW VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. PERSISTENT TYPE I ENDOLEAK DUE TO ANATOMICAL CONDITIONS.
Description of Event or Problem · 1
IN 2008, THE PATIENT WAS IMPLANTED WITH GORE TAG THORACIC ENDOPROSTHESES TO TREAT AN ANEURYSM IN THE DESCENDING THORACIC AORTA. THE PROCEDURE WENT AS PLANNED, BUT A DISTAL TYPE I ENDOLEAK HAS PERSISTED. THE DISTAL END OF THE DEVICE WAS PLACED ON A SUTURE LINE PROXIMAL TO THE CELIAC ARTERY. THE PATIENT IS STABLE WITH NO OTHER COMPLICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GORE TAG THORACIC ENDOPROSTHESIS | NONE | MIH | W.L. GORE & ASSOCIATES | WLG326 | 06187621 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | Other |