(b)(4).Pma/510(k) #p100022/s001.The ziv6-35-125-6.0-120-ptx stent of lot number c776875 was implanted in the patient and is therefore unavailable for evaluation.With the information provided a document based investigation was carried out.It was stated by the originator that there is no imaging available for review or any additional information.There is no evidence to suggest that this event did not occur, therefore the complaint is confirmed based on customer testimony.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 as no imaging was available for review, a definitive root cause of this event cannot be determined at this time.It may be noted that as per the packaging insert, restenosis of the stented artery is a known potential adverse event associated with the 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.Upon review of complaints, this failure mode has occurred previously with the lot number c776875.However, based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with the lot number c776875.Cut balloon was performed against the restenosis.No information regarding patient outcome has been provided.Complaints of this nature will continue to be monitored for any potential emerging trends.
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