Manufacturing review: a lot history review was performed.This is the only complaint to date for this lot number.Therefore, a device history record review is not required.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately, eleven years eleven months of post-deployment, a computed tomography (ct) of the abdomen was revealed the inferior vena cava filter struts extended up to 4 mm beyond the inferior vena cava lumen but without evidence of exertion into the aorta, intestinal loops, or adjacent psoas musculature.Therefore, the investigation is confirmed for the perforation of the 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.(expiry date: 09/2011).
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It was reported through the litigation process that a vena cava filter was deployed successfully, after being diagnosed with pulmonary embolism with contraindications to anticoagulation.Approximately eight years seven months post filter deployment, computed tomography (ct) abdomen was performed and it was alleged that the filter struts perforated.The device has not been removed and there were no attempts made to retrieve the filter.The patient reportedly experienced abdominal pain; however, the current status of the patient is unknown.
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