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.Medical records were provided and reviewed.Approximately one year and eight months later, filter retrieval was scheduled, attempted to snare the inferior vena cava filter percutaneously but after a prolonged attempt filter removal was unsuccessful, and the filter was remained in place.This was apparently because the hook of the filter was either embedded into the wall of the inferior vena cava or covered with fibrin sheath.After ten days, patient was reported abdominal and lower back pain one day after attempted filter removal and that has been persistent since that time.A computerized tomography scan of abdomen and pelvis showed phlebitis of inferior vena cava and bilateral iliac veins and reported thrombus in the inferior vena cava filter.Moderate nonspecific retroperitoneal fat at level of inferior vena cava filter and extended to origin of bilateral external iliac arteries, that was might be related to recent attempt made at inferior vena cava catheter removal and resultant infection was suggested.Therefore, the investigation is confirmed for alleged retrieval difficulties.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.(expiry date: 10/2018).
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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 unable to be retrieved.The device has not been removed after unsuccessful percutaneous removal attempt.The patient reportedly experienced abdominal and back pain; however, the current status of the patient is unknown.
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