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.Incorrect positioning or orientation of the filter is one of the potential complications cited in the ifu associated with this product.In the ifu, step 28 of the recommended filter implantation states ¿perform a control cavagram prior to terminating the procedure.Verify proper filter positioning¿.¿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" 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.
|
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) 2012 by doctor (b)(6) at (b)(6).The patient had a scheduled retrieval approximately 5 years later, on or about (b)(6) 2017 by doctor (b)(6) at (b)(6).The patient alleges the filter was embedded, tilted, perforated and fractured; however the filter was retrieved but the ¿retained strut (is) embedded within the vertebral body.¿ argon¿s attorneys are attempting to gather additional information.
|