FDA Adverse Event
Injury
Summary report: N
GORE HELEX SEPTAL OCCLUDER
MDR report key: 3143006
·
Received May 23, 2013
Report
- Report Number
- 2017233-2013-00323
- Event Type
- Injury
- Date Received
- May 23, 2013
- Date of Event
- May 8, 2013
- Report Date
- May 8, 2013
- 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 MFG RECORDS VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS.
Description of Event or Problem · 1
IT WAS REPORTED THE PHYSICIAN IMPLANTED A 30MM GORE HELEX SEPTAL OCCLUDER TO CLOSE AN ATRIAL SEPTAL DEFECT. THE DEFECT MEASURED 11-13MM WITH A TOTAL SEPTAL LENGTH OF ABOUT 34MM AND NO RETROAORTIC RIM. THE DEVICE WAS LOCKED IN THE DEFECT BUT THE NEXT MORNING THE OCCLUDER HAD EMBOLIZED TO THE PULMONARY ARTERY. IN A SURGICAL PROCEDURE LATER THAT DAY, THE DEVICE WAS REMOVED AND THE DEFECT WAS CLOSED. THE PT WAS DOING WELL FOLLOWING THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 228059 | GORE HELEX SEPTAL OCCLUDER | MLV | W.L. GORE & ASSOCIATES | 10422275 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 3 YR | Other | HEPARIN |