Manufacturing review: a lot history review was performed.This is the only complaint to date for this lot number.Therefore, a device history record (dhr) review is not required.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Post filter inferior vena cavogram revealed, ivc was normal in caliber and course without evidence of intraluminal filing defects.Seven days post filter deployment, patient presented for metastatic disease with cervical cancer evaluation.Subsequent ct revealed, a single nonspecific 5 x 3 mm lung nodule in the right middle lobe.Remaining lungs are clear without infiltrate, suspicious nodule or mass.There are borderline perivascular lymph nodes measuring up to 8 mm.Incidental note of large bilateral pulmonary emboli reported.There were no device deficiencies identified within the medical records.Therefore, the investigation is inconclusive for the alleged perforation of the ivc as no objective evidence has been provided to confirm any alleged deficiency with the filter.Additionally, it can be confirmed that the patient experienced pe post deployment.However, the relationship to the filter is unknown.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: 04/2017).
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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 deep vein thrombosis/pulmonary embolism.At some time post filter deployment, it was alleged that the filter struts perforated into the organs.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.
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