Manufacturing review: a device history record review could not be performed as the lot number is unknown.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Post deployment, fractures and umbrella section with large circumferential impression on the inferior vena cava wall were noted on an unspecified date.The patient had a chronic fractured indwelling inferior vena cava filter.Therefore, the investigation is confirmed for filter limb detachment.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.
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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 strut detached and the patient had extravasation.Attempts were made to retrieve the filter, however removal of the filter was not confirmed.The current status of the patient is unknown.
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