FDA Adverse Event
Death
Summary report: N
CORDIS
MDR report key: 1844075
·
Received September 22, 2010
Report
- Report Number
- 1844075
- Event Type
- Death
- Date Received
- September 22, 2010
- Date of Event
- September 10, 2010
- Report Date
- September 17, 2010
- Manufacturer
- CORDIS CORP
- Product Code
- DTK
- Adverse Event
- Yes
- Report Source
- User Facility report
- Reporter Location
- KS, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
PRE-OP X-RAY ON (B)(6) 2010, SHOWED VENA CAVA FILTER HAD MIGRATED INTO THE RIGHT ATRIUM. THE PROCEDURE TO REMOVE THE FILTER WAS SUCCESSFUL, HOWEVER, THE PT COMPLAINED OF CHEST PAIN AND SHORTNESS OF BREATH IMMEDIATELY UPON REMOVAL. A STAT ECHOCARDIOGRAM SHOWED RIGHT ATRIAL COLLAPSE AND PT STATUS DECLINED RAPIDLY LEADING TO A CODE BLUE, IMMEDIATE TRANSFER TO OPERATING ROOM FOR ATRIAL REPAIR. PT DIED TWO DAYS FOLLOWING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CORDIS | TRAPEASE IVC FILTER | DTK | CORDIS CORP | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Death |