(b)(4).This investigation addresses restenosis of the lesion where (b)(4) of lot c780693 was implanted.The stent remains implanted in the patient.With the information provided, a document based investigation was carried out.According to complaint information provided, worsen rutherford was observed on the patient.The exact stage of rutherford classification is unknown but worsening indicates progression of peripheral artery disease and can be associated with the restenosis process.Restenosis is a common adverse event of endovascular procedures and can be caused by injury to the vessel (e.G.During pta and/or stenting).Vessel injury provokes an inflammatory response that leads to (or amplifies) the restenosis process.It may be noted that surface of the zilver ptx stent is coated with the drug (paclitaxel) to help prevent subsequent restenosis of the artery.It can be therefore stated that it is very unlikely that the reported restenosis could have occurred due to zilver ptx malfunction; however a definitive cause of this event cannot be determined.Due to lack of imaging no other comments can be made.As no imaging was available to support the complaint investigation, the complaint is confirmed based on customer testimony.It may be noted that restenosis of the stented artery is a known potential adverse event associated with placement of this device.Prior to distribution all zilver ptx devices are subject to visual inspection and functional checks to ensure device integrity.A review of the relevant manufacturing records revealed no discrepancies that could have contributed to this complaint.According to information provided, bypass surgery was performed against the restenosis and the patient's condition improved.There have been no further adverse effects to the patient.Quality engineering will continue to monitor complaints of this nature for potential emerging trends.
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