The lot number for the reported malfunction was not provided, therefore, a lot history review will not be performed.The device was not returned for evaluation, however medical records were provided and reviewed.Therefore, the investigation is confirmed for perforation of inferior vena cava (ivc), filter tilt and material deformation.However, the investigation is inconclusive for filter limb detachment and filter migration.Based on the available information, the definitive root cause is unknown.The device is labeled for single use.
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A review of the reported information indicated that model ec500f vena cava filter allegedly experienced perforation, tilt, material deformation, migration and detachment.The information was received from a single source.One patient was involved with no patient consequence.The female patient is (b)(6) years old and weighs (b)(6) pounds.
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