Manufacturing review: a manufacturing review was not requested as the lot number reported as unknown.Investigation summary: the device was not returned for evaluation.Medical records were not provided.The investigation is inconclusive for the alleged filter limb detachment, perforation of the inferior vena cava, filter tilt and retrieval difficulties as no objective evidence has been provided to confirm any alleged deficiency with the filter.A definitive root cause for the alleged filter limb detachment, perforation of the inferior vena cava, filter tilt and retrieval difficulties could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.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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It was reported through the litigation process that a vena cava filter was placed in a patient in conjunction with trauma situation/motor vehicle accident.Approximately seventeen years post filter deployment, it was alleged that the filter tilted, detached and perforated the inferior vena cava.The device was removed after two attempted but unsuccessful procedure.The detached strut retained in lung and the patient experienced pericardial effusion and chest pain; however, the current status of the patent is unknown.
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