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.Approximately after 2 years post filter implant, on (b)(6) 2015, the patient was scheduled for filter removal.The right internal jugular vein was accessed with a 21-guage needle using ultrasound guidance.A 0.18 guide wire was advanced into the superior vena cava under fluoroscopy.The needle was exchanged for a micro puncture sheath.This was used to upsize to a 0.35 system.Next, a 0.35 bentson guide wire was advanced down into the ivc using a kumpe catheter.The guide wire could not be advanced beyond the filter.Digital subtraction injection was performed, which showed extravasation of contrast outside the ivc.Next, the catheter was redirected to beneath the apex of the filter and repeat ivc cavogram performed at this point demonstrated thrombosed ivc at the apex of the filter.Therefore, the investigation is inconclusive for retrieval difficulties.Additionally, it can be confirmed that the patient experienced thrombus above the filter post deployment.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: 07/2015).
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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 was unable to be retrieved.The device has not been removed after an attempted but unsuccessful percutaneous removal procedure.It was further reported that the thrombus was present at the apex of the filter; however, the current status of the patient is unknown.
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