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 eight months of post deployment, a computed tomography of abdomen and pelvis was performed for abdominal pain.The study showed that inferior vena cava filter was noted.Approximately one year eight months later post filter implant, a computed tomography angiography of chest was performed for dyspnea.The study showed that intermediate probability for pulmonary embolism as well as large perfusion defect in the left upper lobe with a peripheral cortical rim of enhancement.Around, three months later, a computed tomography of abdomen and pelvis was performed for abdominal distention.The study showed that infra renal inferior vena cava filter was noted.Around, three years and four months later, a computed tomography of abdomen and pelvis was performed for lower abdominal pain.The study showed that inferior vena cava filter was noted in place.Around, one year and five months later, a computed tomography angiogram of chest was performed for suspected pulmonary embolism.The study showed that negative for pulmonary embolus on large main branch, saddle, or segmental region.Around, three weeks later, a computed tomography angiogram of chest was performed which showed negative for central pulmonary embolism.Therefore, the investigation is inconclusive as no objective evidence has been provided to confirm any alleged deficiency with the filter.Additionally, it can be confirmed that the patient experienced pulmonary embolism (pe) post deployment.However, the relationship to the filter is unknown.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: 10/2017).
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