FDA Adverse Event
Death
Summary report: N
VENA TECH LGM VENA CAVA FILTER
MDR report key: 341773
·
Received July 13, 2001
Report
- Report Number
- 341773
- Event Type
- Death
- Date Received
- July 13, 2001
- Date of Event
- July 13, 2001
- Report Date
- July 13, 2001
- Manufacturer
- B. BRAUM MEDICAL INC
- Product Code
- DTK
- Report Source
- User Facility report
- Reporter Location
- MI, US
- Reporter Occupation
- INVALID DATA
Narratives
Description of Event or Problem · 1
PT UNDERWENT PROCEDURE TO HAVE VENA CAVA FILTER PLACED FOR THROMBUS. BRAUN VENA TECH VENA CAVA FILTER PLACED IN THE INFRARENAL INFERIOR VENA CAVA. SUCCESSFUL DEPLOYMENT CONFIRMED BY CT OF ABDOMEN AND PELVIS THE SAME DAY. THREE DAYS LATER IN THE EVENING , PT BEGAN TO BE SHORT OF BREATH, PORTABLE CHEST X-RAY SHOWED IVC FILTER TO HAVE MIGRATED INTO THE HEART. PT EXPIRED AT 00:01 THE NEXT DAY AUTOPSY BEING DONE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 32088 | VENA TECH LGM VENA CAVA FILTER | * | DTK | B. BRAUM MEDICAL INC | * | F0146700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Death |