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 tilt, filter migration, filter limb 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 limb detachment and perforation of the inferior vena cava 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 ten years and four months post filter deployment, it was alleged the filter tilted, migrated, detached, and struts perforated through the inferior vena cava wall with one strut extending to the wall of the aorta.The current status of the patient is unknown.
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