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 two months of post deployment, a computed tomography (ct) abdomen was revealed that the filter was mildly tilted, however the apex does not touch the wall of the inferior vena cava.There are 6 additional struts perforating the wall of the inferior vena cava, right lateral, right anterolateral, right posterior lateral, left lateral, left anterolateral and left posterior lateral without involvement of adjacent structures.All the arms and legs of the filter have penetrated through the wall of the inferior vena cava.One leg was in contact with the right lateral wall of the aorta concerning for aortic perforation.One leg was in contact with an intervertebral disc concerning for disc perforation.Two legs have penetrated the anterior aspect of the right psoas muscle.One of the arms on the left lateral side of the filter was bent.One of the legs on the right side of the filter was deformed where the leg attaches to the cone and was bent.The patient experiences abdominal pain.Therefore, the investigation is confirmed for filter tilt, perforation of the inferior vena cava (ivc) and material deformation.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.
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It was reported through the litigation process that a vena cava filter was placed in a patient after being diagnosed with thromboembolic disease.Approximately eleven years and two months post filter deployment, a computed tomography (ct) scan revealed that the filter struts perforated, tilted and strut bended.The device has not been removed and there were no reported 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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