As the lot number for the device was not provided, a manufacturing review could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instruction for use (ifu) is adequate for the reported device/patient and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.
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It was reported through the results of a clinical trial that approximately two months post vena cava filter deployment, patient experienced dvt.It was further reported that intervention was performed and patient hospitalized on (b)(6) 2016.Reportedly, the patient approximately expired one month post admission when the event was ongoing.
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