Model Number UNK776 |
Device Problem
Peeled/Delaminated (1454)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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Device is combination product.Sato, takao, et.Al., 'comparison of clinical outcomes of coronary artery stent implantation in patients with end-state chronic kidney disease including hemodialysis for three everolimus eluting (ees) stent designs: bioresorbablye polymer-ees, platinum chromium-ees, ad cobalt chrome-ees', j interven cardiol.2018;31:170-176.Https//doi.Org/10.1111/joic.12469."effectiveness study of cocr-dp-ees, ptcr-dp-ees and bp-ees in cases with end-stage ckd including dialysis patients", coronary intervention vol.14, no.1, 2018:129-132.(b)(4).Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.(b)(4).[sato.Pdf, coronary intervention vol 14 no1 2018.Pdf].
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Event Description
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Same journal articles as mdr# 2134265-2018-05050.It was reported via journal article that stent delamination occurred.Patients presented to the emergency room with suspected acute coronary syndrome.One-hundred-forty-one consecutive stents from three stent groups, including 44 synergy stents, were implanted in 104 patients with chronic kidney disease (ckd).The following outcome variables were compared among the three stent groups after implantation and the 12-month follow-up: target lesion revascularization (tlr), stent thrombosis (st), and mace.Minimal stent diameter and percentage of diameter-stenosis were measured using quantitative coronary angiography.Immediately after implantation, the minimal stent diameter and percentage of diameter-stenosis were equivalent among the three groups.At follow-up, a tendency towards higher tlr was observed for the synergy group compared with the other groups.Late loss in lumen diameter was also significantly greater for the synergy group.There was no incidence of stent thrombosis.It was concluded that synergy might increase the risk of in-stent restenosis in patients with late stage ckd or the need for hemodialysis (hd).It is possible that the biodegradation of the polymer coat of the synergy stent after implantation might cause a greater inflammation than fluoropolymer, such as the inflammation caused by bioresorbable vascular scaffolds.Several studies have reported that greater inflammation correlates with greater neointimal proliferation in bare metal stents and drug eluting stents (des).In the synergy design, the polymer coat is applied only to the abluminal surface of the stent, unlike the other two des groups included in the study in which the polymer is applied to the entire surface of the stent.It is possible that delamination of abluminal bioabsorbable polymer may occur more easily and severely when it is delivered through a calcified coronary artery, resulting in the attenuation of medicine effectiveness, which likely explains the greater late lumen loss for the synergy stent.
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Search Alerts/Recalls
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