Two ziv6-35-125-6.0-120-ptx and one ziv6-35-125-7.0-120-ptx stents were placed on the right leg on (b)(6) 2012.Two ziv6-35-125-6.0-120-ptx and one ziv6-35-125-6.0-60-ptx stents were then placed on the left leg on (b)(6) 2012.On (b)(6) 2014, restenosis and worsen rutherford was confirmed in both legs.Pta was performed on both legs on the same day.The pt recovered on (b)(6) 2014.This report is in relation to one of the ziv6-35-125-6.0-120-ptx devices placed on the right leg on (b)(6) 2012.As per the above description of events received, six devices in total are involved in this incident.Five add'l separate reports will be submitted in relation to the other devices reported.Report reference nos: 3001845648-2014-00292, 00293, 00294, 00295 and 00296.
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Pma/510 (k) #: p100022/s001.(b)(4).Incident requires fda mdr report based on the surgical intervention carried out due to the occurrence of restenosis in the lesion where a ptx stent was indwelling.The device involved in this complaint is as follows: ziv6-35-125-6.0-120-ptx of lot number c778568.The stent in question remains implanted in the pt and therefore is not available for eval.With the info provided, a document based investigation was carried out.No images in relation to the reported event were provided.It may be noted that 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 (or amplifies) to the restenosis process.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 for zilver ptx devices revealed no discrepancies which could have contributed to this complaint issue.Due to the lack of images for review and as the conditions of use cannot be replicated in a laboratory setting, it is not possible to conclusively determine the root cause for this complaint at this time.The complaint is confirmed based on customer testimony.As per the info provided following pta, the pt recovered.The risk associated with this complaint has been assessed by quality engineering and determined to be low.Complaints of this nature will continue to be monitored for potential emerging trends.
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