As the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation; however, medical records were provided for review.The investigation of the reported event is currently underway.Medical device expiry date: 01/2014.
|
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 perforated.The device has not been removed and there were no reported attempts made to retrieve the filter.The patient reportedly experienced abdominal pain; however, the current status of the patient is unknown.
|
H10: 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 eight years and one month later, computed tomography (ct) revealed anchoring struts extended beyond the vessel wall distally.There was no tilt, bend, or breakage of the device.Therefore, the investigation is confirmed for perforation of the inferior vena cava (ivc).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.H10:d4 (expiry date: 01/2014), g4.H11:section a through f - the information provided by bd 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 bd.
|
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 perforated.The device has not been removed and there were no reported attempts made to retrieve the filter.The patient reportedly experienced abdominal pain; however, the current status of the patient is unknown.
|