Pma/510(k)#: p100022 and s001.(b)(4).The ziv6-35-125-6.0-120-ptx stent of lot number c776874 was implanted in the pt therefore is not available for eval.With the info provided a document based investigation was carried out.It may be noted that restenosis is a common adverse event of endovascular procedures and can be caused by injury to the vessel (eg during pta and/or stenting).Vessel injury provokes an inflammatory response that leads to (or amplifies) the restenosis process.It is very unlikely that restenosis could have occurred due to zilver ptx malfunction; however, a definitive root cause of this stent restenosis cannot be determined.No imaging or other info was available to support the complaint investigation, therefore no other comments can be made.As no imaging was available, the complaint is confirmed based on customer testimony.It may be noted that restenosis of the stented artery is 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 mfg records revealed no discrepancies that could have contributed to this complaint.According to info provided, pta was performed and also another stent was additionally placed.The pt had a favourable outcome.Quality engineering will continue to monitor complaints of this nature for potential emerging trends.
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