Manufacturing review: the lot number has been provided and the lot device history records have been reviewed.The lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint reported for this lot number and issue to date.Medical records review: the patient with a history of deep vein thrombosis and pulmonary embolism had a vena cava filter successfully deployed prior to an upcoming orthopedic surgery.Approximately five years six months post filter deployment, a ct of the abdomen and pelvis demonstrated filter limb perforation with no extension into the aorta seen.The current status of the patient is unknown.Investigation summary: the device was not returned for evaluation.Images were not provided for review.Medical records were provided and reviewed.Approximately five years and six months post filter deployment, a ct of the abdomen and pelvis demonstrated filter limb perforation greater than 3 mm outside of the ivc with no extension into the aorta seen.Therefore, the investigation for the alleged perforation of the ivc is confirmed.Based upon the available information, the definitive root cause is unknown.Labeling review: the current ifu (instructions for use) states: potential complications: -perforation or other acute or chronic damage of the ivc wall the information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
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