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 2 years post filter deployment, the patient stated with history of abdominal pain.A computerized tomography revealed one of the prongs of the filter was noted extending to left renal vein.Eventually a few days later, x-ray abdomen revealed stable positioning of the inferior vena cava filter at the level of l2 and l3 with a slight tilt.Therefore, the investigation is confirmed for perforation of the inferior vena cava (ivc).However, the investigation is inconclusive for filter tilt as the medical records state ¿slight tilt¿.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.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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