FDA Adverse Event
Injury
Summary report: N
GORE TAG THORACIC ENDOPROSTHESIS
MDR report key: 1101471
·
Received August 6, 2008
Report
- Report Number
- 2017233-2008-00434
- Event Type
- Injury
- Date Received
- August 6, 2008
- Date of Event
- July 17, 2008
- Report Date
- August 6, 2008
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- MIH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
A REVIEW OF THE MFG PAPERWORK IS BEING CONDUCTED.
Description of Event or Problem · 1
AS REPORTED, IN 2008, THIS PT WAS IMPLANTED WITH A GORE TAG THORACIC ENDOPROSTHESIS. AT AN UNK DATE, IMAGING DEMONSTRATED THAT THE GRAFT HAD COLLAPSED. TWO MONTHS LATER, THE PT UNDERWENT A REINTERVENTION IN WHICH ANGIOPLASTY WAS PERFORMED AND THREE PALMAZ STENTS WERE IMPLANTED. PT IS IN STABLE CONDITION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GORE TAG THORACIC ENDOPROSTHESIS | NONE | MIH | W.L. GORE & ASSOCIATES | WLG326 | 05897133 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Required Intervention |