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, seven years seven months of post deployment, a computed tomography (ct) abdomen and pelvis was revealed two filters are present, one in the right external iliac and second in the left common iliac veins.A total of 4 prongs have perforated the inferior vena cava and maximum distance prongs perforated was 8mm.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: (expiry date: 12/2012).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.
|