Manufacturing review: the device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only event reported to date for this lot number and failure mode.Medical records review: the patient with history of deep vein thrombosis and pulmonary embolism had a vena cava filter deployed in the infrarenal ivc.Approximately four years eight months post filter deployment, ct scan performed for complaint of abdominal pain demonstrated a migrated and tilted filter with multiple limbs extending beyond the caval wall with at least two limbs abutting the abdominal aorta.The filter was going to be removed and replaced if all other causes were ruled out as a source of pain.Approximately four years ten months post filter deployment, the filter was removed without difficulty.Investigation summary: the device was not returned for evaluation.Images were not provided for review.Medical records were provided and reviewed.Based on the medical records, the investigation can be confirmed for tilted filter and perforation of the ivc.However, the investigation is inconclusive for filter migration.Based upon the available information, the definitive root cause is unknown.Labeling review: the current ifu (instructions for use) states: warnings/potential complications: movement, migration or tilt of the filter are known complications of vena cava filters.Perforation or other acute or chronic damage of the ivc wall.Filter tilt.Filter malposition.Note: it is possible that complications such as those described in the "warnings", "precautions", or "potential complications" sections of this instructions for use may affect the recoverability of the device and result in the clinician's decision to have the device remain permanently implanted.The information provided by bard 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 bard.
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