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, four years one month post deployment the patient experienced chest pain and possible pulmonary embolus, computed tomography angiogram of chest with contrast was performed which showed moderate-sized acute pulmonary embolus lodged in the branches and extending into one of the segmental left upper lobe branches, there was no pulmonary emboli on the right.Given that this was a pulmonary infarction related to the left lower lobe pulmonary embolus.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 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: 02/2015).
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