FDA Adverse Event
Injury
Summary report: N
OPTEASE VENA CAVA FILTER
MDR report key: 1111741
·
Received August 12, 2008
Report
- Report Number
- 9610978-2008-00206
- Event Type
- Injury
- Date Received
- August 12, 2008
- Date of Event
- July 11, 2008
- Report Date
- July 16, 2008
- Manufacturer
- CORDIS EUROPA, N.V.
- Product Code
- DTK
- PMA / PMN Number
- K034050
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT IS NOT AVAILABLE FOR ANALYSIS. ADD'L INFO WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.
Description of Event or Problem · 1
THE MALE PT RECEIVED AN OPTEASE RETRIEVABLE FILTER. THE PT HAD SEVERE SWELLING FROM THE WAIST DOWN 2 DAYS AFTER THE OPTEASE WAS IMPLANTED. VENEGRAM WAS PERFORMED AND ACUTE THROMBOSIS WAS DISCOVERED IN THE OPTEASE RETRIEVABLE FILTER. THROMBOLYSIS WAS PERFORMED ON BOTH LEGS AND THE CLOT WAS ANGIOJETTED OUT OF BOTH LEGS. THEY WERE ABLE TO REMOVE THE OPTEASE FILTER. THE PT IS DOING WELL, HOWEVER STILL HAS SWELLING OF THE SCROTUM AND PENIS. PER THE SALES REP ANGIO SHOWED NARROWING OF ILIAC VEINS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OPTEASE VENA CAVA FILTER | THROMBECTOMY SYSTEMS (DTK) | DTK | CORDIS EUROPA, N.V. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Required Intervention |