FDA Adverse Event
Injury
Summary report: N
VENATECH LP VENA CAVA FILTER
MDR report key: 1328795
·
Received February 18, 2009
Report
- Report Number
- 3006332832-2009-00002_
- Event Type
- Injury
- Date Received
- February 18, 2009
- Date of Event
- December 31, 2008
- Report Date
- February 17, 2009
- Manufacturer
- B. BRAUN MEDICAL SAS
- Product Code
- DTK
- Adverse Event
- Yes
- Report Source
- Distributor report
Narratives
Description of Event or Problem · 1
A VENATECH LP FILTER WAS IMPLANTED ON 2008 IS AN OBESE FEMALE PT WITHOUT INCIDENT AND APPEARED WELL POSITIONED. TWO MONTHS LATER, 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 PT WAS POSITIVE FOR PULMONARY EMBOLISM. THE PT HAD NOT UNDERGONE ANY INTERVENTIONS IN THE 2-WEEK PERIOD BETWEEN IMPLANT AND THE DATE OF EVENT. THE PT 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 |