Manufacturing review: a lot history review was performed.This is the only complaint to date for this lot number.Therefore, a device history record review is not required.Investigation summary: the device was not returned for evaluation.The medical records included images.The image review was documented in the medical records.Medical records were provided and reviewed.Approximately one year and eight months post filter deployment, computed tomography (ct) was performed and compared with previous report and revealed that inferior vena cava filter was in place below the renal veins.There was no filter migration.The filter was abnormally tilted posteriorly approximately 15-degrees.Two of the anterior struts penetrated vena cava position between the vena cava and the duodenum.A left lateral strut penetrated the vena cava and was in contact with the right lateral wall of the abdominal aorta.Subsequently, the patient was expired.Therefore, the investigation is confirmed for perforation of the inferior vena cava (ivc).However, the investigation is unconfirmed for filter tilt, as the medical records state that the filter was tilted by approximately 15 degrees.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: (b)(6) 2015).
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