The catalog number identified in has not been cleared in the us, but is similar to the fluency plus endovascular stent graft products that are cleared in the us.The 510 k number and pro code for the fluency plus endovascular stent graft products are identified.As the lot number for the device was not provided, a manufacturing review could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.(b)(4).Journal article citation: luo, j., li, m., zhang, y., wang, h., huang, m., li, z., ¿ jiang, z.(2018).Percutaneous transhepatic intrahepatic portosystemic shunt for variceal bleeding with chronic portal vein occlusion after splenectomy.European radiology, 28(9), 3661¿3668.Doi: 10.1007/s00330-018-5360-z.
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