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.There were no device deficiencies identified within the medical records.Therefore, the investigation is inconclusive as no objective evidence has been provided to confirm any alleged deficiency with the filter.Additionally, it can be confirmed that the patient experienced thrombus above the filter post deployment.However, the relationship to the filter is unknown.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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It was reported through the litigation process that a vena cava filter was placed in a patient for unknown reason.At some time, post filter deployment, it was alleged that the patient was diagnosed with thrombus above the filter.The device has not been removed and there were no reported attempts made to retrieve the filter.The current status of the patient is unknown.
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