FDA Adverse Event
Injury
Summary report: N
GORE HELEX SEPTAL OCCLUDER
MDR report key: 1241728
·
Received November 20, 2008
Report
- Report Number
- 2017233-2008-00891
- Event Type
- Injury
- Date Received
- November 20, 2008
- Date of Event
- November 4, 2008
- Report Date
- November 20, 2008
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- MLV
- PMA / PMN Number
- P050006
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, 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.
Description of Event or Problem · 1
THE PATIENT HAD A HELEX SEPTAL OCCLUDER IMPLANTED IN 2005. THE EXPLANTING PHYSICIAN STATED THAT THERE HAD BEEN DISPLACEMENT OF THE DEVICE COMPARED TO HIS PREVIOUS EVALUATIONS. THE PHYSICIAN CHOSE TO REMOVE THE DEVICE, AND REPAIR THE DEFECT SURGICALLY. THE PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GORE HELEX SEPTAL OCCLUDER | NONE | MLV | W.L. GORE & ASSOCIATES | WLG216 | 02307392 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 16 YR | Hospitalization |