Manufacturing review: a device history record review could not be performed as the lot number is unknown.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately one year and one month of post deployment, the patient complaints of right upper quadrant pain.Four years and three months later, a computed tomography (ct) abdomen and pelvis was performed and it revealed that the filter appears angulated slightly towards the left at the l2-l3 level again with a leg projecting beyond the inferior vena cava lumen, but there does not appear to definitely be erosion into the aorta.No fractured leg was seen.Therefore, the investigation is confirmed for perforation of inferior vena cava (ivc).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.
|
It was reported through the litigation process that a vena cava filter was placed in a patient after being diagnosed with pulmonary embolism.Approximately five years and four months post filter deployment, a computed tomography (ct) scan revealed that the filter struts perforated.The device has not been removed and there were no reported attempts made to retrieve the filter.The patient reportedly experienced right upper quadrant pain; however, the current status of the patient is unknown.
|