FDA Adverse Event
Injury
Summary report: N
VENATECH LP VENA CAVA FILTER
MDR report key: 1305604
·
Received February 2, 2009
Report
- Report Number
- 3006332832-2009-00002
- Event Type
- Injury
- Date Received
- February 2, 2009
- Date of Event
- December 31, 2008
- Report Date
- January 29, 2009
- Manufacturer
- B. BRAUN MEDICAL SAS
- Product Code
- DTK
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- WI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
A VENATECH LP FILTER WAS IMPLANTED IN (B)(6) 2008 IN AN OBESE FEMALE PATIENT WITHOUT INCIDENT AND APPEARED WELL POSITIONED. ON (B)(6)2008, THE PT RETURNED FOR A ROUTINE FOLLOW UP CT SCAN. THE FILTER WAS NOTED TO BE DAMAGED AND LOCATED IN THE INTRA-HEPATIC PORTION OF THE IVC. THE PATIENT WAS POSITIVE FOR PULMONARY EMBOLISM. THE PATIENT HAD NOT UNDERGONE ANY INTERVENTIONS IN THE 2-WEEK PERIOD BETWEEN IMPLANT AND THE DATE OF THE EVENT. THE PATIENT IS CURRENTLY STABLE. THE LOT NUMBER OF THE DEVICE HAS NOT BEEN PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VENATECH LP VENA CAVA FILTER | VENA CAVA FILTER | DTK | B. BRAUN MEDICAL SAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Life Threatening |