Manufacturing review: the device history record review could not be performed as the lot number is unknown.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Post filter deployment, computed tomography of abdomen and pelvis was performed which revealed there was a birds nest type of inferior vena cava filter with its proximal tip roughly 5mm inferior to the left renal vein, the distal prongs do appear to extend minimally beyond the wall of the inferior vena cava but not into adjacent organs.One year and one month later, computed tomography of abdomen was performed which revealed there was an infrarenal inferior vena cava filter, which appears to represent a simon nitinol filter.The top of the filter was below the lowest renal vein by 4.8cm.There was no significant filter tilting.There was a right anterolateral filter leg which is outside of the vena cava wall with 2.5mm of perforation.There was a right posterolateral filter leg which was perforated beyond the inferior vena cava filter wall up to 5mm.Right posterior filter leg was perforated beyond the inferior vena cava wall to 5mm and in the right anterolateral paravertebral space.Left posterior leg was perforated beyond the inferior vena cava wall by 2mm and in the ventral paravertebral space.No definite filter leg fracture or bending.Therefore, the investigation is confirmed for perforation of inferior vena cava (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.
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