DENALI FEMORAL SYSTEM Adverse Event — Injury (MDR 2020394-2020-03284)
DENALI FEMORAL SYSTEM Adverse Event — Injury (MDR 2020394-2020-03284) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: DENALI FEMORAL SYSTEM; Generic name: VENA CAVA FILTER; Manufacturer: BARD PERIPHERAL VASCULAR, INC..
| Device | DENALI FEMORAL SYSTEM |
|---|---|
| Generic name | VENA CAVA FILTER |
| Manufacturer | BARD PERIPHERAL VASCULAR, INC. |
| Report number | 2020394-2020-03284 |
| Event type | Injury |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | CONSUMER, HEALTH PROFESSIONAL |
| Narrative | IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT A VENA CAVA FILTER WAS PLACED IN A PATIENT AFTER BEING DIAGNOSED WITH DEEP VEIN THROMBOSIS/PULMONARY EMBOLISM. AT SOME TIME, POST FILTER DEPLOYMENT, IT WAS ALLEGED THAT THE FILTER DETACHED, MIGRATED, PERFORATED, TILTED AND EMBEDDED IN THE WALL OF IVC. THE DEVICE HAS NOT BEEN REMOVED AFTER AN ATTEMPTED BUT UNSUCCESSFUL PERCUTANEOUS REMOVAL PROCEDU |
| Source | openFDA MAUDE (device adverse events) |
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