The ziv6-35-125-6-80-ptx stent of lot number c936398 was implanted in the patient therefore is not available for evaluation.With the information provided a document based investigation was carried out.Images were available to support the complaint investigation.The following comments were provided by the independent reviewer "findings:.Year follow up ultrasound demonstrated mild neointimal hyperplasia on color flow doppler but no significant stenosis on pulse wave doppler.Fourteen months later severe stenosis on color flow and pulse wave doppler developed in the mid to distal stented segment.Mild stenosis was present in the proximal stented segment.Impression:.Although no imaging from the complaint event was provided, two months prior to the occlusion the mid to distal stented segment was severely narrowed from neointimal hyperplasia.Factors increasing restenosis occlusion risk include an untreated stenosis, poor runoff, long stented length, small vessels, and severe atherosclerotic disease".Based on the image review, the customer complaint could be confirmed as two months prior to the occlusion the mid to distal stented segment was severely narrowed from neointimal hyperplasia.It can be noted that neointimal hyperplasia is the major cause of restenosis that occurs after interventions such as stenting or angioplasty.Restenosis is a common adverse event of endovascular procedures and can be caused by injury to the vessel (e g dunng 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.According to the independent reviewer, factors increasing restenosis occlusion risk include an untreated stenosis, poor runoff, long stented length, small vessels, and severe atherosclerotic disease.Moreover, the physician has indicated that the pre-existing condition of peripheral vascular disease caused or contributed to the event.It can be therefore stated that it is very unlikely that the event could have occurred due to zilver ptx malfunction.As per instruction for use, 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.Treatment included balloon angioplasty and stent placement.No adverse effects to the patient have been reported.Quality engineering will continue to monitor complaints of this nature for potential emerging trends.
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This follow up report is being submitted to include the investigation conclusions.Protocol 12-004, patient (b)(4).On (b)(6) 2015, the pt was diagnosed with an occlusion/restenosis in the left distal sfa within the study lesion.Treatment included balloon angioplasty and stent placement.The physician indicated that the event was thought to definitely be related to the study product and that the pre-existing condition of peripheral vascular disease cause or contributed to the event is unknown if imaging is yet available.This report addresses one ziv6-35-125-6-80 ptx stent.An add'l separate report has been submitted in relation to the second stent.Report reference number 3001845648-2015-00124.The event end date was noted to be (b)(6) 2015.
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