Manufacturing review: the device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process, and quality control testing.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.Approximately six years and ten months later, abdomen multiple views was performed for abdominal pain showed that an inferior vena cava filter overlay right side of l2 and l3 vertebral bodies and did not appear significantly changed in position since with the previous computed tomography observation.After one year and six months, computed tomography of abdomen without contrast was performed, and result showed that there was a bard inferior vena cava filter in place.There was a pronounced degree of angulation of the filter off the long axis of the inferior vena cava.On the coronal reformatted images, the filter demonstrated approximately 30¿ tilt off the long axis of the inferior vena cava.The apex of the filter was just below the inflow of the left renal vein into the inferior vena cava.There were some focal hyperdensities seen in the right lung centrally difficult to determine if these represent small embolized filter fragments of fractured legs or small cement emboli given the fact that the patient had undergone previous vertebroplasty.There was penetration of all of the legs of the filter, ranging from 2 mm of penetration along the left side of the cava, with more pronounced leg penetration along the right side and more inferiorly where the leg penetration reached 10-12 mm.No definite evidence of any penetration of the legs into an e neighboring visceral were anatomic structures included aorta, bowel riding solid organs.Therefore, the investigation is confirmed for the alleged filter tilt and perforation of the inferior vena cava.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: 10/2012).
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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 filter tilted, struts perforated and the patient reportedly experienced abdominal pain.The device has not been removed after an attempted but unsuccessful percutaneous removal procedure.However, the current status of the patient is unknown.
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