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 five years post filter deployment, a vena cavogram was done which showed that small tiny thrombi at the level of vena cava filter, vena cava filter review showed that it is tilted to the left with its apex, but the exact location of filter could not be determined.There was good flow; however, of the contrast column all the way up to the vena cava without any obstruction.After three days patient remained in a critical condition and reference was made of a prior venogram which revealed migration of the inferior vena cava filter towards the renal vein.After one year filter retrieval was planned.Access was gained via the right internal jugular vein.There was an inferior vena cava filter in place.The filter was tilted and its hook was embedded in the retroperitoneal tissues.Multiple attempts did to retrieve the filter.Approximately after four years patient had chest pain.Computed tomography was done and filter was tilted with struts leaning towards the right lower quadrant.One strut perforated body of pancreas.Another strut was fractured and extended anterolaterally to the right perforating pancreatic head.Third strut extended laterally to the right perforating proximal duodenum.The hook of the filter was embedded within left wall of inferior vena cava.Therefore, the investigation is confirmed for perforation of the ivc, filter limb detachment, filter migration, filter tilt and retrieval difficulties.However, the investigation is inconclusive for pe post implant and thrombus above the filter.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: 03/2018), (b)(4).
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It was reported through the litigation process that a vena cava filter was placed in a patient in conjunction with or before orthopedic procedure.At some time post filter deployment, it was alleged that the filter tilted, migrated, struts detached and perforated into the organs.The device and detached strut were not removed after an attempted but unsuccessful percutaneous removal procedure.It was further reported that the thrombus was found at the apex of the filter and the patient was diagnosed with pulmonary embolism post implant; however, the current status of the patient is unknown.
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