Manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: the device was not returned for evaluation.Medical records were not provided.The investigation is inconclusive for the alleged filter tilt, filter migration, filter detachment and perforation of the inferior vena cava as no objective evidence has been provided to confirm any alleged deficiency with the filter.A definitive root cause for the alleged filter tilt, filter migration, filter detachment and perforation of the inferior vena cava 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.
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