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 migration, perforation of the inferior vena cava and the filter limb detachment as no objective evidence has been provided to confirm any alleged deficiency with the filter.A definitive root cause for the alleged filter migration, perforation of the inferior vena cava and the filter limb detachment could not be determined based upon the provided information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.
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It was reported through the litigation process that approximately four years and seven months post filter deployment, it was alleged the filter migrated, detached, struts perforated and pierced through the inferior vena cava wall.The current status of the patient is unknown.
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