The device has not been returned for evaluation and no images or videos have been provided of the filter in-vivo, so the complaint cannot be confirmed.If additional information is provided in the future, this issue will be reevaluated as needed.¿device breakage or failure or inability to retrieve implanted device as described in ifu, possibly requiring another intervention or treatment modality to complete procedure¿ is one of the potential complications cited in the ifu associated with this product.
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According to the notice received by way of a civil action complaint filed on march 15, 2018, the patient was prescribed and implanted with an option elite retrievable ivc filter on or about (b)(6) 2015 by dr.(b)(6) at (b)(6) hospital in (b)(6).The patient had a scheduled retrieval approximately 5 months later, on or about (b)(6) 2016 by dr.(b)(6).The physician was unable to retrieve the filter due to tilt and embedment and the filter was found to have fractured in which the fractured pieces allegedly migrated to the patient right atrium of his heart.The patient had a second scheduled retrieval approximately 1 week later, on or about (b)(6) 2016 by drs.(b)(6) at (b)(6) hospital in (b)(6).The pathology report indicated the ¿filter consisted of multiple loose wires.¿ the patient underwent retrieval of the fractured pieces 1 day later, on or about (b)(6) 2016 by drs.(b)(6).One (1) filter fragment was retrieved and it was later discovered by chest x-ray that 2 additional filter fragments remain in the right atrium of the patient¿s heart.The patient alleges ¿significant injuries, including, but not limited to, the embedment of the filter¿s retrieval hook, tilt of the filter, migration of the filter, fracture of the filter, perforation of the vena cava by the filter, perforation of the plaintiff¿s heart by the filter, damage to the plaintiff¿s vena cava, heart, and other organs, multiple retrieval surgeries, the need for future surgeries to retrieve fractured pieces of the option elite.¿.
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