Catalog Number UNKENTERPRISE |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Thromboembolism (2654)
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Event Date 06/23/2023 |
Event Type
Injury
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Event Description
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This complaint is from a literature source and the following citation was reviewed: li z, xuan j, fang x, zhao x, zhang b, wu d, lai n, liu j, zhang z, yuan j, qin f.Comparison of enterprise stent 2 with 1 in assisting coiling of ruptured aneurysms: a real-world study.J comp eff res.2022 aug;11(12):879-887.Doi: 10.2217/cer-2022-0005.Epub 2022 jun 23.Pmid: 35734978.Purpose/objective/methods:aim: to investigate the effectiveness and safety of the enterprise 2 (e2) stent versus the enterprise 1 (e1) stent in treating ruptured intracranial aneurysms (rias) in china.Materials & methods: the authors conducted an electronic medical record analysis for patients with rias who underwent e1/e2 deployment.The main outcomes were immediate complete occlusion (ico), patient functional outcomes, complications and aneurysm recurrence.Results: stent deployment was successful in all patients (e2: 90; e1: 270).Ico and patients with good functional outcomes at discharge were similar between e2 and e1 (80.0% vs 75.1% and 78.7% vs 81.1%, respectively).The e2 group had a significantly lower complication rate compared with the e1 group (7.8% vs 16.4%; odds ratio: 0.36; 95% ci: 0.15¿0.91; p = 0.031).By 6 months post-discharge, the two groups had comparable patient functional outcomes and aneurysm recurrence (e2 vs e1: 80.2% vs 81.9% and 13.3% vs 14.9%).Conclusion: compared with the e1 stent, the e2 stent had similar effectiveness but a lower complication risk in treating rias.Lot, model and catalog number are not available, but the suspected cerenovus device possibly associated with reported adverse events: enterprise stent cerenovus devices that were used in this study: enterprise 2 stent (no in-stent thrombosis reported) non-cerenovus devices that were also used in this study: n/a.Exact product quantities cannot be determined as a patients can experience more than one adverse event.Adverse event(s) and provided interventions possibly associated with unidentified enterprise stent: qty 10 in-stent thrombosis treated with tirofiban was given through microcatheter or guiding catheter and pumped intravenously at the same time.
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Manufacturer Narrative
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Manufacturer¿s ref.No: (b)(4).This complaint is from a literature source and the following citation was reviewed: li z, xuan j, fang x, zhao x, zhang b, wu d, lai n, liu j, zhang z, yuan j, qin f.Comparison of enterprise stent 2 with 1 in assisting coiling of ruptured aneurysms: a real-world study.J comp eff res.2022 aug;11(12):879-887.Doi: 10.2217/cer-2022-0005.Epub 2022 jun 23.Pmid: 35734978.Section d.4: the product catalog and lot numbers are not available / not reported.The unique identifier (udi) and expiration date of the device is not known.Section e.1: the initial reporter phone is not available / reported.Section h.4: the device manufacture date is not known as the device lot number is not available / not reported.Since the event is life threatening and it might result in permanent impairment of a body function or permanent damage to a body structure; or it could require medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious.The event is reportable to the us fda.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by cerenovus, or its employees that the report constitutes an admission that the product, cerenovus, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.The article is too large to attach to the medwatch report.The digital objective identifier link to the article is: doi: 10.2217/cer-2022-0005.
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Search Alerts/Recalls
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