Manufacturing review: a lot history review was performed.This is the only complaint to date for this lot number.Therefore, a device history record (dhr) review is not required.Investigation summary: the device was not returned for evaluation.Images were not provided.Medical records were provided and reviewed.Subsequently, post filter deployment, ct revealed extensive bilateral pulmonary emboli with right heart strain and pulmonary hypertension for which the patient was treated with anticoagulants and discharged.Approximately one month later, ct revealed the ivc filter with 2 strips penetrating the ivc and 1 protruding into the duodenal lumen.The filter was retrieved successfully.Therefore, the investigation is confirmed for perforation of the ivc.Additionally, it can be confirmed that the patient experienced pe post deployment.However, the relationship to the filter is unknown.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: 02/2019).
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It was reported through the litigation process that a vena cava filter was placed in a patient due to factor 5 lieden.At some time post filter deployment, it was alleged that the filter perforated into the vein and duodenum.The device was removed percutaneously.The patient reportedly experienced bilateral pulmonary embolism post filter implant and developed mssa infection blood sepsis; however, the current status of the patient is unknown.
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