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.Medical records were provided and reviewed.Cava filter was somewhat tilted overlying the l3 vertebral body as well as left iliac venous stents.Subsequently on the same day, the patient presented with abdominal and back pain.A computed tomography revealed that the posterior leg of the filter had penetrated the l3 vertebra.The hook was partially embedded in the right caval wall.Five months later, there was occlusion of the inferior vena cava at the level of filter.A few attempts were made to cross the inferior vena cava occlusion from this location, but they were all unsuccessful.Multiple attempts were made to capture the filter using both forceps and snares.However, these were all unsuccessful.Therefore, the investigation is confirmed for perforation of the inferior vena cava (ivc), filter migration, occlusion of the inferior vena cava (ivc) filter and retrieval difficulties.Additionally, it can be confirmed that the patient experienced pe post deployment and thrombus above the filter.However, the relationship to the filter is unknown.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: 12/2021), (b)(4).
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It was reported through the litigation process that a vena cava filter was deployed successfully, after being diagnosed with deep vein thrombosis and pulmonary embolism.At some time post filter deployment, it was alleged that the filter tilted, migrated, occluded at the level of filter, was unable to be retrieved and struts perforated.The patient was reportedly diagnosed with thrombus above the filter and pulmonary embolism.The patient also reportedly experienced abdominal and back pain.The device has not been removed after several unsuccessful attempts made to retrieve the filter.The current status of the patient is unknown.
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