The 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.Approximately two years and ten months of post deployment, a computed tomography of chest, abdomen and pelvis was performed which showed inferior vena cava filter was noted with calcified thrombus above the filter.Around four months later, a computed tomography of chest, abdomen and pelvis was performed which showed inferior vena cava filter was noted with calcified thrombus in the inferior vena cava.Therefore, the investigation is inconclusive for perforation of inferior vena cava (ivc).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 after being diagnosed with deep vein thrombosis/pulmonary embolism.At some time post filter deployment, it was alleged that the filter struts perforated.The device has not been removed and there were no reported attempts made to retrieve the filter.The patient was diagnosed with thrombus; however, the current status of the patient is unknown.
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