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¿, "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.In the optional procedure for filter retrieval section of the ifu, it states: ¿if the filter is retrieved, it should be done within 175 days following implant.¿ this device can remain permanently implanted.
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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 retrievable ivc filter on or about (b)(6) 2014 by dr.(b)(6) and dr.(b)(6) at the (b)(6) medical center in (b)(6).The patient alleges that approximately 15 months later, on or about (b)(6) 2015 the filter was found to have tilted and the ¿medial struts of the argon option ivc filter extends outside of the lumen of the inferior vena cava.¿ no attempt has been made to retrieve the filter; therefore, it remains implanted.Argon¿s attorneys are attempting to gather additional information.
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