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.Medical records were provided and reviewed.Approximately four years and nine months post filter deployment, patient had a history of abdominal pain.Subsequent, computed tomography revealed inferior migration of the inferior vena cava filter roughly 3.5 cm below the level of the renal vein confluence and circumferential spindle perforation inferiorly through the inferior vena cava wall.Therefore, the investigation is confirmed for perforation of the inferior vena cava (ivc) and filter migration.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: 03/2017).
|
It was reported through the litigation process that a vena cava filter was placed in a patient after being diagnosed with pulmonary embolism.Approximately four years and nine months post filter deployment, a computed tomography (ct) revealed the filter migrated and strut perforated.The device has not been removed and there were no reported attempts made to retrieve the filter.The patient reportedly experienced abdominal; however, the current status of the patient is unknown.
|