Manufacturing review: the device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process, and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the device was not returned for evaluation.The medical records included images.The image review was documented in the medical records.Medical records were provided and reviewed.Approximately ten years later, computerized tomography-abdomen without contrast was performed which showed that there was an inferior vena cava filter present below the renal veins.The filter legs and penetrated through the wall of the inferior vena cava into the pericaval/mesenteric fat.A filter leg has penetrated the disc.A filter leg has penetrated the duodenum.Therefore, the investigation is confirmed for alleged perforation of the inferior vena cava.Based upon 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: 06/2010).
|
It was reported through the litigation process that a vena cava filter was placed in a patient after being diagnosed with deep vein thrombosis/pulmonary embolism.Approximately ten years and one month post filter deployment, the patient allegedly had a computed tomography (ct) scan that showed the inferior vena cava filter perforating the inferior vena cava wall / duodenum.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.
|