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: 12/2008.
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H10: manufacturing review: the device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process, and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately, twelve years ten months of post deployment, the patient experienced abdominal pelvic pain and computerized tomography-abdomen was revealed inferior vena cava filter in place, complicated in appearance.The struts of the filter were extended beyond the wall of the inferior vena cava, a common finding.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: 12/2008).H11: h6 (result and conclusion).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.
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