FDA Adverse Event
Injury
Summary report: N
UNKNOWN
MDR report key: 3926119
·
Received July 1, 2014
Report
- Report Number
- 1820334-2014-00289
- Event Type
- Injury
- Date Received
- July 1, 2014
- Date of Event
- July 9, 2013
- Report Date
- May 30, 2019
- Manufacturer
- WILLIAM COOK EUROPE
- Product Code
- DTK
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
(B)(4). EVENT EVALUATION: STILL UNDER INVESTIGATION.
Description of Event or Problem · 1
PER LAWSUIT FILED, IT IS ALLEGED: A FEMALE PATIENT WITH RECURRENT DVT'S IN HER LEG UNDERWENT IVC FILTER PLACEMENT WITH A GUNTHER TULIP FILTER ON (B)(6) 2008. THERE WERE NO REPORTED COMPLICATIONS AT THE TIME. THE ALLEGATIONS OF THE LAWSUIT ARE: ON OR ABOUT (B)(6) 2013, THE PATIENT PRESENTED TO THE HOSPITAL TO HAVE THE COOK GUNTHER TULIP FILTER REMOVED. UNFORTUNATELY, THE ENTIRE FILTER WAS UNABLE TO BE REMOVED. UPON CLOSER EXAMINATION, IT WAS DISCOVERED THAT SEVERAL STRUTS OF THE FILTER HAD PERFORATED THE PATIENT'S VENA CAVA. PARTS OF THE COOK GUNTHER TULIP FILTER REMAIN INSIDE THE PATIENT. AS OF (B)(6) 2014 NO ADDITIONAL INFORMATION HAS BEEN PROVIDED BY THE REPORTER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 381600 | UNKNOWN | DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR | DTK | WILLIAM COOK EUROPE | NA | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Life Threatening| O |