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
Occlusion (1984); Claudication (2550); Surgical procedure, additional (2564)
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Event Date 10/27/2014 |
Event Type
Injury
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Event Description
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On (b)(6) 2012 ziv6-35-125-6.0-120-ptx (lot #c778923) was placed at right popa (above the knee).On (b)(6) 2014 patient had shown worsening claudication.Angiography confirmed the occlusion at the lesion where the ptx was placed.The physician suspected thrombosis in the ptx and applied suctioning to the thrombosis, however, it was impossible.Then based on this, the physician though it was not thrombosis, and placed the smart stent (6cm x 15cm) inside of the ptx.On (b)(6) 2014 there have been no further adverse effects to the patient reported as occurring as a result of this incident.
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Manufacturer Narrative
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Pma/510(k)#: p100022 and s001.(b)(4).Incident requires fda mdr report based on the surgical intervention carried out as a result of the suspected occlusion of the zilver ptx stent.Although it cannot be confirmed if thrombosis was the cause of the worsened claudication following the additional procedure, the surgical intervention was still carried out under the suspicion of acute thrombosis.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.Although requested images relating to this event have not been received.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.Restenosis of the stented artery is a known potential adverse event associated with the placement of the device.The complaint is confirmed based on customer testimony.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.Due to the lack of images no other comments can be provided at this time.Quality engineering will continue to monitor complaints of this nature for potential emerging trends.Quality engineering assessed the complaint and the risk has been determined to be low.
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