Manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.After post filter deployment, computed tomography (ct) revealed that single leg of the filter had broken off and embolized to the right lower lobe posterior basilar segment artery.Approximately two years and three months later, the patient presented for filter removal using real-time sonographic guidance.The g2 recovery retrievable filter removal cone system was placed through the sheath.Then the filter retrieval cone was placed over the apex of the filter.The retrieval cone was then compressed with the sheath, results in retraction of the filter legs.The filter was then removed in its entirety.The patient had dislodged filter, which was partially retrieved.Approximately eight months and twenty-one days later, computed tomography (ct) revealed that there was a thin linear hyper-density along the distal right lower lobe pulmonary artery branch without arterial thrombosis or pulmonary parenchymal abnormalities, that may represent radiopaque foreign body related to part of the filter.The patient reportedly experienced chest pain.Therefore, the investigation is confirmed for the alleged filter limb detachment.The definitive root cause could not be determined based upon available information.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.(expiry date: 11/2010).
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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.At some time post filter deployment, it was alleged that the single leg of the filter had broken off.The device has been removed percutaneously.The patient reportedly experienced chest pain.However, the current status of the patient is unknown.
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