Manufacturing review: a lot history review was performed.This is the only complaint to date for this lot number.Therefore, a device history record (dhr) review is not required.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Eventually, x-ray performed on an unspecified date revealed fractured migrated leg in the left lung.Approximately seven years post filter deployment, patient presented for filter retrieval.Venogram performed revealed filter at the level of l3 with 5 arms and 6 legs.Scout radiograph of the left chest demonstrated previously fractured filter arm fragment overlying the left hemothorax.Subsequently, the filter was carefully sheathed, and retrieved.One previously fractured filter arm fragment was retained in the left lung.Therefore, the investigation is confirmed for filter limb detachment.However, the investigation is inconclusive for perforation of the ivc.Based upon the available information, the definitive root cause is unknown.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, and unit label) showed that the product labeling is adequate.(expiry date: 03/2012).
|
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 and in conjunction with trauma situation/motor vehicle accident.At some time post filter deployment, it was alleged that the filter detached and struts perforated.The device was removed.It was further reported that the detached strut migrated to the left lung and the patient experienced chest pain; however, the current status of the patient is unknown.
|