FDA Adverse Event
Death
Summary report: N
BARD
MDR report key: 2081799
·
Received May 3, 2011
Report
- Report Number
- MW5020493
- Event Type
- Death
- Date Received
- May 3, 2011
- Date of Event
- July 23, 2009
- Report Date
- May 3, 2011
- Manufacturer
- BARD MEDICAL DIV.
- Product Code
- DTK
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- NC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IVC FILTER STRUT FRACTURE WITH MIGRATION OF STRUT TO A PERIPHERAL PULMONARY ARTERY POSITION. BARD G2 EXPRESS FILTER IMPLANTED ON (B)(6) 2009 AND PT UNDERWENT GASTRIC OUTLET PROCEDURE FOR MORBID OBESITY LATER THAT DAY. STRUT IN PULMONARY ARTERY POSITION NOTED RETROSPECTIVELY ON CHEST IMAGE OF (B)(6) 2009. ATTEMPT AT REMOVAL OF FILTER TO BE UNDERTAKEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BARD | BARD G2 EXPRESS VENA CAVA FILTER | DTK | BARD MEDICAL DIV. | GFTC2587 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 33 YR | Congenital Anomaly| D| H| L| O| R| S |