The main objective of this ambispective, single center, nonrandomized, single-arm, physician-driven study was to evaluate the patency of the zilver® vena¿ venous self-expanding stent (i.E., the zilver® vena¿ venous stent) in patients undergoing venous stenting.This report focuses on data from the 239 patients that had a zilver vena venous stent placed at an index procedure.Patient 96 had restenosis and required a stent replacement, restenosis.Time to diagnosis 882 days.Related to device; not related to procedure.Imaging modality to diagnose event ultrasound/x-ray.Days to reintervention 1101.Reintervention additional stent placement.Patient outcome: patient required imaging and stent replacement.
|
Common name: qan.Pma/510(k) # p200023.Device evaluation.The device evaluation could not be completed as the device or photographic evidence of the device was not returned for evaluation.With the information provided, a document-based investigation was conducted.This file is related to (b)(4).Lab evaluation ¿ n/a document review prior to distribution all zilver vena devices are subjected to a visual inspection and functional inspection to ensure device integrity.It should be noted that the instructions for use (ifu0047) lists restenosis or thrombosis of the stented vein as a potential adverse event.There is no evidence to suggest the user did not follow the ifu.There is no evidence to suggest that the customer did not follow the label.Image review an image was not returned for evaluation.Root cause review a definitive root cause could not be determined however a possible root cause can be attributed to known potential complications.The ifu lists restenosis or thrombosis of the stented vein as a potential adverse event.Summary the complaint is confirmed based on customer testimony.The complaint was raised from the clinical study ¿evaluation of the zilver vena venous stent in spain ¿ dr.Marta ramirez ortega (physician ¿ driven study ¿ ambispective review of patients undergoing proximal venous stent placement).According to the literature paper, 07 patients experienced restenosis.This complaint captures 01 case of restenosis requiring a stent replacement at 1101 days.As per medical advisor input ¿require intervention/additional procedures to prevent permanent impairment/damage¿ complaints of this nature will continue to be monitored for potential emerging trends.
|