MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL UNKENTERPRISE2; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number UNKENTERPRISE2

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

Patient Problems Stroke/CVA (1770); Thromboembolism (2654); Restenosis (4576)

Event Date 03/10/2009

Event Type  Injury  

Event Description

This complaint is from a literature source and the following citation was reviewed: siddiqui ma, j bhattacharya j, lindsay kw, jenkins s.Horizontal stent-assisted coil embolisation of wide-necked intracranial aneurysms with the enterprise stent--a case series with early angiographic follow-up.Neuroradiology.2009 jun;51(6):411-8.Doi: 10.1007/s00234-009-0517-8.Epub 2009 mar 10.Pmid: 19277620.Background and purpose: the purpose of the study is to describe our experience in eight cases of horizontal stenting across the circle of willis in patients with terminal aneurysms.Eight patients were treated with horizontal stent placement and aneurysm coiling.All aneurysms had highly unfavourable dome to neck ratios.All patients were followed up with digital subtraction angiography at 3¿12 months following treatment.Cerenovus devices that were used in this study: qty 8 enterprise stents.Adverse event(s) and provided interventions associated with enterprise stent: qty 1: asymptomatic case of in-stent stenosis.Qty 1: in-stent thrombus found at 12 month follow-up.Qty 1: incident of a small right thalamic infarct.Treatments not listed.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).This complaint is from a literature source and the following citation was reviewed: siddiqui ma, j bhattacharya j, lindsay kw, jenkins s.Horizontal stent-assisted coil embolisation of wide-necked intracranial aneurysms with the enterprise stent--a case series with early angiographic follow-up.Neuroradiology.2009 jun;51(6):411-8.Doi: 10.1007/s00234-009-0517-8.Epub 2009 mar 10.Pmid: 19277620.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: initial reporter address line 2: department of neuroradiology, institute of neurological sciences.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.

• Brand Name: UNKENTERPRISE2
• 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: 18548225
• MDR Text Key: 333315294
• Report Number: 3008114965-2024-00094
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 01/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKENTERPRISE2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2024
• 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