Manufacturing review: 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 nine months post filter deployment, patient presented with history of abdominal pain.Subsequent computed tomography, revealed an inferior vena cava filter was present.Thrombus might be present inferior to that extending into the iliac veins.Abdominal x-rays demonstrated inferior vena cava filter was present at the level of l4.Approximately eight months post filter deployment, patient diagnosed with pulmonary embolism.Patient was protected from a large pulmonary embolism with the inferior vena cava filter, but patient still might have small pulmonary embolisms.That was acceptable as it was unlikely to succumb to small pulmonary embolisms.Approximately one year later, computed tomography revealed the filter was tilted anteriorly with its cone lying on the wall of the inferior vena cava, possibly embedded within it.The legs of the filter had penetrated through the wall of the inferior vena cava into the pericaval/mesenteric fat.There were only 5 filter arms identified.There should be 6 arms.One of the arms was presumably fractured and migrated.Therefore, the investigation is confirmed for perforation of the inferior vena cava (ivc), filter limb detachment and filter tilt.Additionally, it can be confirmed that the patient experienced pulmonary embolism 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.
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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 and pulmonary embolism.At some time post filter deployment, it was alleged that the filter tilted, struts detached and perforated.The device has not been removed and there were no reported attempts made to retrieve the filter.The patient reportedly diagnosed with pulmonary embolism post implant and experienced abdominal pain; however, the current status of the patient is unknown.
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