FDA Adverse Event
Injury
Summary report: N
VENA TECH
MDR report key: 219237
·
Received April 15, 1999
Report
- Report Number
- 2523676-1999-00010
- Event Type
- Injury
- Date Received
- April 15, 1999
- Date of Event
- February 25, 1999
- Report Date
- April 9, 1999
- Manufacturer
- B. BRAUN MEDICAL, INC.
- Product Code
- DTK
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
A VENA TECH INFERIOR VENA CAVA FILTER WAS SUCCESSFULLY PLACED SUPRA RENAL ON DECEMBER 10, 1994. ON FEBRUARY 17, 1999, THE PT RETURNED TO THE HOSP COMPLAINING OF PAIN IN THE ABDOMINAL AREA. A CHEST X-RAY REVEALED THAT TWO STABILIZING LEGS AND TWO CAMBERED LEGS OF THE INFERIOR VENA CAVA FILTER HAD BROKEN OFF AND WERE POTENTIALLY LODGED IN THE RIGHT RENAL VEIN. THE REMAINDER OF THE FILTER WAS INTACT AND SITTING BELOW THE LOWEST RENAL VEIN. THE PT IS SCHEDULED FOR A CT SCAN IN APRIL DETERMINE THE EXACT WHEREABOUTS OF THE FILTER AND LEGS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VENA TECH Implant | VENA TECH VENA CAVA FILTER | DTK | B. BRAUN MEDICAL, INC. | 30CF/U | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 27 YR | Required Intervention |