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 nine years of post deployment, computed tomography of abdomen showed that an inferior vena cava filter was present with the superior filter apex located 1.9 cm inferior to the right renal vein.The proximal filer contacted the anterior wall of the inferior vena cava with an anterior tilt measured approximately 20 degrees.There were multiple struts with exited appearance from the inferior vena cava.A posterior right-sided inferior vena cava strut exited the inferior vena cava for 1.7 cm extended towards the lumbar spine and contacted an osteophyte from the lumbar spine.There was a second posterior left sided strut which exited the inferior vena cava 0.9 cm contacted osteophyte of the lumbar spine and extended into the right psoas muscle.An adjacent strut exited the inferior vena cava 0.7 cm and coursed posterior to the abdominal aorta.An anterior strut exited left of midline 0.5 cm.An anterior strut exited 0.5 cm and contacted a posterior wall of small bowel without intraluminal extension.Along the right lateral aspect of the inferior vena cava, a strut exited 0.7 cm and contacted the ventral surface of the right ureter.A small metallic density within the right psoas muscle measured 0.2 x 0.2 cm.This was below the level of the inferior vena cava strut and might represent a small fracture of the strut.The inferior vena cava was normal in caliber without stenosis.Therefore, the investigation is confirmed for filter tilt, filter limb detachment and perforation of inferior vena cava (ivc).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: 03/2011).
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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 tilted, strut detached and perforated.It was further reported that the right -sided exited strut contacts right ureter, posterior struts contact spine and anterior strut contacts posterior wall of small bowel.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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