FDA Adverse Event
Death
Summary report: N
GUNTHER TULIP NAVALIGN FEMORAL VENA CAVA FILTER SET
MDR report key: 8815324
·
Received July 23, 2019
Report
- Report Number
- 3002808486-2019-01033
- Event Type
- Death
- Date Received
- July 23, 2019
- Date of Event
- March 23, 2018
- Report Date
- July 23, 2019
- Manufacturer
- WILLIAM COOK EUROPE
- Product Code
- DTK
- UDI-DI
- 10827002529172
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
MANUFACTURERS REF#: (B)(4). PMA/510(K) #: K172557. (B)(4). INVESTIGATION IS STILL IN PROGRESS.
Description of Event or Problem · 1
DESCRIPTION OF EVENT ACCORDING TO STUDY: ON (B)(6) 2018, WHILE THE FILTER WAS BEING REMOVED THERE WAS A TEAR IN THE INNOMINATE VEIN CAUSING MASSIVE HEMORRHAGE, AND SUBJECT DIED. THE EVENT WAS CONSIDERED POSSIBLY RELATED TO THE IVC FILTER OR PROCEDURE. PATIENT OUTCOME: THE PATIENT DIED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 611437 | GUNTHER TULIP NAVALIGN FEMORAL VENA CAVA FILTER SET | DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR | DTK | WILLIAM COOK EUROPE | G52917 | E3644717 | 10827002529172 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Death |