FDA Adverse Event
Death
Summary report: N
VENA TECH-LGM
MDR report key: 124222
·
Received October 1, 1997
Report
- Report Number
- 124222
- Event Type
- Death
- Date Received
- October 1, 1997
- Date of Event
- September 26, 1997
- Report Date
- September 30, 1997
- Manufacturer
- VENA TECH B. BRAUN MEDICAL
- Product Code
- DTK
- Report Source
- User Facility report
- Reporter Location
- OH, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
A VENA CAVA FILTER WAS IMPLANTED IN THE PT. IT FAILED TO DEPLOY AND MIGRATED TO THE HEART. IT BECAME LODGED IN THE PULMONARY ARTERY. THE PT SUBSEQUENTLY DIED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VENA TECH-LGM Implant | VENA CAVA FILTER | DTK | VENA TECH B. BRAUN MEDICAL | 31327 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 38 YR | Death |