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, three years and three months of post deployment, a computed tomography of chest, abdomen and pelvis was performed for respiratory distress.The study showed that positive for pulmonary embolism within the segmental and sub segmental pulmonary arteries of the left lower lobe.Thrombus was noted within the inferior vena cava, above the level of filter, likely source of pulmonary embolism.Around, nine months later, a computed tomography of chest, abdomen and pelvis was performed for mid back pain.The study showed that inferior vena cava filter was noted.There were no device deficiencies identified within the medical records.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 pe (pulmonary embolism) and thrombus above the filter 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: 08/2014).
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