Manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately, eleven years and seven months of post deployment, computed tomography of abdomen was revealed, the tip of inferior vena cava filter was just below the renal veins.There was perforation of the inferior vena cava filter struts which perforated left lateral aspect and posterior aspect.With the left anterior lateral stress perforates the aortic wall as well.There was mild right tilt of the inferior vena cava filter approximately 15-20 degrees.Therefore, the investigation is confirmed for the perforation of the inferior vena cava (ivc) and filter tilt.The definitive root cause could not be determined based upon available information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.Expiry date: 12/2010.
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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 pulmonary embolus.At some time, post filter deployment, it was alleged that the filter had perforated and tilted.The device has not been removed and there were no reported attempts made to retrieve the filter.The current status of the patient is unknown.
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