MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL STENT - VASCULAR RECONSTRUCTION; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number UNKENTERPRISE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thromboembolism (2654)

Event Date 06/23/2023

Event Type  Injury  

Event Description

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.

Manufacturer Narrative

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.

• Brand Name: STENT - VASCULAR RECONSTRUCTION
• Type of Device: INTRACRANIAL NEUROVASCULAR STENT
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• Manufacturer (Section G): CERENOVUS INC; 325 paramount dr; raynham MA 02767
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 303552-689
• MDR Report Key: 17281432
• MDR Text Key: 318644201
• Report Number: 3008114965-2023-00471
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: H60001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKENTERPRISE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening