FDA Adverse Event
Injury
Summary report: N
GORE HELEX SEPTAL OCCLUDER
MDR report key: 1211758
·
Received October 24, 2008
Report
- Report Number
- 2017233-2008-00790
- Event Type
- Injury
- Date Received
- October 24, 2008
- Date of Event
- September 17, 2008
- Report Date
- October 24, 2008
- Manufacturer
- W.L. GORE & ASSOCIATES, INC
- Product Code
- MLV
- PMA / PMN Number
- P050006
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE REMAINS IMPLANTED IN THE PATIENT. A REVIEW OF THE MANUFACTURING PAPERWORK. RESULTS - THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PHYSICIAN IMPLANTED A HELEX SEPTAL OCCLUDER TO CLOSE A PFO (PATENT FORAMEN OVALE) IN 2008. THE PATIENT AWOKE FROM THE GENERAL ANESTHESIA, WITH A RIGHT HEMISPHERIC STROKE (CVA). THE DEVICE REMAINS IMPLANTED AND IN GOOD POSITION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GORE HELEX SEPTAL OCCLUDER | NONE | MLV | W.L. GORE & ASSOCIATES, INC | WLG216 | 06056998 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR |