H10: manufacturing review: the device history records have been reviewed and 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 eight years of post-deployment, computerized tomography lumbar spine demonstrated a retrievable vena cava filter at the level of l3.There was a leg penetration through the inferior vena cava 0.6 cm, behind the aorta.Around, eleven months later, computerized tomography-abdomen was revealed that tip off the vena cava filter was at the l3 vertebral body level.The inferior struts of the vena caval filter extended beyond the lumen of the inferior vena cava and particularly involved the medial and posterior struts of the vena cava filter.Therefore, the investigation is confirmed for the perforation of the inferior vena cava (ivc).The definitive root cause could not be determined based upon available information.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H10: d4(expiry date: 06/2011), g4.H11: h6 (results, conclusion).H11: section a through f: the information provide by bd represents all 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.H3 other text : device not returned.
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