Manufacturing review: a lot history review was performed.This is the only complaint to date for this lot number.Therefore, a device history record review is not required.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.The medical records allege bard g2 filter was implanted in the level of the l2, l3 intervertebral space location for a patient.The filter appeared to be well-lodged, it appeared to be stationary, and the sheath and vena cava filter apparatus was removed.Post procedure x-ray was taken which showed vena cava filter to be migrated all the way up to the level of the l1 vertebral body.Subsequently, another x-ray was taken which showed the vena cava filter no longer in the abdominal cavity and a chest x-ray was performed which showed the vena cava filter to be in the right atrium and right ventricle.Patient was transferred to another hospital for endovascular retrieval of inferior vena cava filter.Therefore, the investigation is confirmed for the alleged filter migration.Based on 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.
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