Manufacturing review: 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.This is the only event reported to date for this lot number and failure mode.Medical record review: patient with multi-lower extremity fractures and likely prolonged immobility had vena cava filter placed infrarenal.Approximately three years eleven months post filter deployment, abdomen/pelvis ct showed the vena cava filter in the infrarenal position with the lower portion of the legs appearing to protrude through the caval wall.Approximately six years seven months post filter deployment, ct venogram of the abdomen/pelvis showed vena cava filter at l3, six hooked and two non-hooked struts of the filter had perforated the inferior vena cava, two struts had perforated the third portion of the duodenum, and the filter apex had a bullet shape without a hook.Investigation summary: the device was not returned.Medical records were provided.Based on the medical record review the investigation is confirmed for filter limb perforation.Based upon the available information, the definitive root cause is unknown.Labeling review: the current ifu (instructions for use) states: potential complications.Perforation or other acute or chronic damage of the ivc wall.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
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It was reported through the litigation process that a vena cava filter was placed in a patient in conjunction with trauma situation/motor vehicle accident.At some time post filter deployment, it was alleged that the filter perforated the vena cava wall and duodenum.The device has not been removed; however, there were no reported attempts made to retrieve the filter.The status of the patient is unknown.
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