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¿, "death", "filter migration/movement", "incorrect positioning or orientation of the filter", "vena cava or other vessel injury or damage, including rupture or dissection, possibly requiring surgical repair or intervention", "thromboembolic events, including dvt, acute or recurrent pulmonary embolism or air embolism, possibly causing end organ infarction/damage/failure", and "injury or damage to organs adjacent to vena cava, possibly requiring surgical repair or intervention" are 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 (b)(6) 2017 , the patient was prescribed and implanted with an option elite retrievable ivc filter on or about (b)(6) 2014 by dr.(b)96) at (b)(6) medical center in (b)(6).The patient had a scheduled retrieval procedure approximately 20 months later, on or about (b)(6) 2016 by dr.(b)(6) at (b)(6) medical center in (b)(6) but the physician was unable to do so due to breakthrough pulmonary embolism; filter thrombosis post implant, embedment and tilt.Argon¿s attorneys are attempting to gather additional information.
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