COOK IRELAND LTD ZILVER PTX DRUG-ELUTING PERIPHERAL STENT; NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
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Catalog Number ZIV6-35-125-6.0-120-PTX |
Device Problem
Occlusion Within Device (1423)
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Patient Problems
Reocclusion (1985); Surgery, prolonged (2177); Claudication (2550)
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Event Date 10/25/2014 |
Event Type
Injury
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Event Description
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On (b)(6) 2012 two zilver ptx stents (2 x ziv6-35-125-6.0-120-ptx) were placed in the left sfa.On (b)(6) 2014, occlusion due to restenosis in both two stents was confirmed.Worsen rutherford, rest pain and worsen claudication were observed.Pta (poba) was performed.The patient did not recover.Reference reports 3001845648-2014-00276 and 3001845648-2014-00277 for this event.On (b)(6) 2014, occlusion due to restenosis in both stents was confirmed again.Worsen rutherford, rest pain and worsen claudication were observed.Bypass was then performed and the patient recovered.This report is in relation to one of the zilver ptx devices for the event on (b)(6) 2014.Reference related report 3001845648-2014-00280 for the second device.
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Manufacturer Narrative
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(b)(4).Incident requires fda mdr report based on the surgical intervention carried out due to the occurrence of occlusion in the lesion where a ptx stent was indwelling.This investigation addresses 1 x ziv6-35-125-6.0-120-ptx of lot c781168.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.Images were not available ot support the complaint investigation.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 (or amplifies) to the restenosis process.Worsened claudication/rest pain and restenosis of the stented artery are known potential adverse events associated with the placement of this device.Summary of comments provided by the physician and sales rep were as follows: "i reckon that reocclusion was unavoidable due to severe lesion".The complaint is confirmed based on customer testimony.A review of the manufacturing records for ziv6-35-125-6.0-120-ptx device of lot # c781168 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.Complaints of this nature will continue to be monitored for emerging trends.
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