FDA Adverse Event
Injury
Summary report: N
GORE HELEX SEPTAL OCCLUDER
MDR report key: 1231923
·
Received November 13, 2008
Report
- Report Number
- 2017233-2008-00866
- Event Type
- Injury
- Date Received
- November 13, 2008
- Date of Event
- October 17, 2008
- Report Date
- November 13, 2008
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- MLV
- PMA / PMN Number
- P050006
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
A REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. A REVIEW OF THE IMAGES HAS BEEN CONDUCTED. 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 IN 2008, TO CLOSE AN ASD (ATRIAL SEPTAL DEFECT). AT A ONE MONTH FOLLOW-UP VISIT, FLUOROSCOPY IMAGES SHOWED FRAME FRACTURES OF THE LEFT AND RIGHT DISCS. THERE WAS ALSO EXCESSIVE MOTION OF THE POSTERIOR-SUPERIOR PORTION OF THE LEFT DISC IN THE REGION OF THE PULMONARY VEINS INFLOW. THE DEVICE WAS REMOVED THREE MONTHS LATER, AND THE DEFECT WAS SURGICALLY CLOSED. THE PT WAS DOING WELL AFTER 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 | 05666335 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 4 YR | Required Intervention |