Pma/510(k)#: p100022/s001.(b)(4).This incident meets the reporting criteria of an fda mdr report based on the surgical intervention carried out as a result of occurrence of restenosis while a zilver ptx stent was indwelling in the lesion.The zilver ptx device involved in this complaint was implanted in the patient therefore is not available for evaluation.With the information provided, a document based investigation was carried out.It may be noted that re-stenosis 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.Additional comment from the physician is as follows: "it was unusual restenosis." restenosis, worsened claudication of the stented artery are known potential adverse events associated with the placement of this device.A review of the manufacturing records revealed no discrepancies related to this complaint issue.Prior to distribution all zilver ptx devices are subject to visual inspection and functional checks to ensure device integrity.Since there are no images available for review, there is no evidence to suggest that re-stenosis did not occur.The complaint is confirmed based on customer testimony.Quality engineering assessed the complaint and the risk has been determined to be low.Quality engineering will continue to monitor complaints of this nature for potential emerging trends.
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