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 three months post filter deployment, the patient presented with abdominal pain.Eventually ten days later, xr-kidney ureter scan revealed inferior vena cava umbrella in place.Subsequently nine years and two months computed tomography (ct) revealed there was an infrarenal vena cava filter.The apex was cranial and was located centrally within the inferior vena cava without significant tilt.Almost all of the filter struts were seen piercing through the walls of the vena cava.Therefore, the investigation is confirmed for the perforation of the 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: 09/2010).
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It was reported through the litigation process that a vena cava filter was deployed successfully, the reason for the filter deployment was not provided.At some time post filter deployment, it was alleged that the filter struts perforated the mesentery.The device has not been removed and there were no reported attempts made to retrieve the filter.The patient reportedly experienced internal bleeding; however, the current status of the patient is unknown.
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