Manufacturing review: the device history record review could not be performed as the lot number is unknown.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately three months post filter deployment inferior vena cava filter retrieval attempt was performed.Using the bard retrieval kit, attempt was made to grab the hook of the filter.Despite multiple attempts, it was unsuccessful.Bentson guidewire was snared.Both ends of the guidewire were pulled to reset the filter in a different location of the inferior vena cava for approximately 1/2 cm above the initial location.The bentson wire and neff catheter were removed.Using a cook retrieval kit, repeat attempt to snare the filter was made.That was unsuccessful.An ensnare was used and that was also unsuccessful.The procedure was aborted.Inferior venacavogram demonstrated a tiny amount of thrombus or fibrin sheath at the tip of the inferior vena cava filter.Approximately a few days later, another attempt was made to retrieve the filter.By pulling both ends of the bentson guidewire, the inferior vena cava filter was pulled into the sheath and retrieved outside the patient's body.Therefore, the investigation is confirmed for retrieval difficulties.Additionally, it can be confirmed that the patient experienced thrombus above the filter post deployment.However, the relationship to the filter is unknown.Based upon the available information, the definitive root cause is unknown.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, and unit label) showed that the product labeling is adequate.
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