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.The medical records included images.The image review was documented in the medical records.Medical records were provided and reviewed.Approximately, six years seven months of post deployment, computed tomography of the abdomen and pelvis with contrast revealed some of the filter struts had penetrated through the wall of the inferior vena cava into the pericaval/mesenteric fat.The filter was tilted posteriorly with its proximal cone laid on the wall of the inferior vena cava possibly embedded in it.Around, two days later, intravascular ultrasound revealed chronic thrombotic changes towards the vena cava filter, a minimal thrombus above the filter and occlusion of the filter with thrombosis.Therefore, the investigation is confirmed for the perforation of the inferior vena cava, occlusion of the inferior vena cava filter and filter tilt.Additionally, it can be confirmed that the patient experienced thrombus above the filter post deployment.However, the relationship to the filter is unknown.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: 08/2014).
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It was reported through the litigation process that a vena cava filter was placed in a patient in conjunction with trauma situation/motor vehicle accident.Approximately six years and seven months post filter deployment, it was alleged that the filter perforated the vena cava, tilted and computed tomography scan showed a clot in the filter and caval thrombosis.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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