The catalog number identified has not been cleared in the us, but is similar to the venovo venous stent products that are cleared in the us.The pro code and 510 k number for the venovo venous stent 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.Journal article citation: rodriguez-morata, a., robles-martin, m.L., & reyes-ortega, j.P.(2019).Endovascular treatment of posterior nutcracker syndrome with a new autoexpandable stent.Journal of vascular surgery: venous and lymphatic disorders, 7(1), 118¿121.Doi: 10.1016/j.Jvsv.2018.06.008.
|
It was reported in an article from the journal of vascular surgery: venous and lymphatic disorders titled " endovascular treatment of posterior nutcracker syndrome with a new autoexpandable stent " that two cases with a posterior nutcracker syndrome (pns) were treated with a stenting of the left renal vein via a complete endovascular approach.In the immediate postoperative period, both patients had back pain at the dorsal lumbar level and the medical treatment has been acetylsalicylic acid at low doses.This pain approximately lasted for 3 weeks.At 17-month follow-up for case one and 9-month follow-up for case two, the patients were clinically well and asymptomatic.The postoperative back pain in the early postoperative period is due to the pressure of the self-expanding stent on the spine.
|