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 Problems Stroke/CVA (1770); Hemorrhage/Bleeding (1888); Thrombosis/Thrombus (4440)

Event Date 11/18/2021

Event Type  Injury  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).This complaint is from a literature source and the following citation was reviewed: chien sc, chen cc, chen ct, wang ay, hsieh pc, yeap mc, liu zh, wang yc, liu yt.Ticagrelor versus clopidogrel in stent-assisted coil embolization of unruptured intracranial aneurysms.Interv neuroradiol.2021 nov 18:15910199211054959.Doi: 10.1177/15910199211054959.Epub ahead of print.Pmid: 34792425.The product catalog and lot numbers are not available / not reported.The unique identifier (udi) and expiration date of the device is not known.The initial reporter phone is not available.Initial reporter address line 2: (b)(6).The device manufacture date is not known as the device lot number is not available / not reported.Due to the nature of the complaint, the device (s) were not returned for analysis nor was the sterile lot numbers provided in order to conduct a lot history review.As a result, we are closing this investigation.If the complaint device is received in the future, we will reopen the complaint and perform the investigation as appropriate.Infarction, ischemia, stroke and thrombosis are known potential adverse events associated with the enterprise stent and is listed in the instructions for use (ifu) as such.The coil-assisted stent embolization procedure also increases the risks for these events especially with anti-dual platelet therapy.There is no indication of any device malfunction or defect per the content of the literature.Since these adverse events can possibly be related to the device and/or the procedure, this complaint meets the mdr reporting criteria.The complaint will be updated with any additional information received from performing follow-up activity with the corresponding author, and reportability will be reassessed as needed.There is no indication that the enterprise malfunctioned or that these events are related to the device design or manufacturing process.This report is being submitted pursuant to the provisions of 21 cfr, part 4.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.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.

Event Description

This complaint is from a literature source and the following citation was reviewed: chien sc, chen cc, chen ct, wang ay, hsieh pc, yeap mc, liu zh, wang yc, liu yt.Ticagrelor versus clopidogrel in stent-assisted coil embolization of unruptured intracranial aneurysms.Interv neuroradiol.2021 nov 18:15910199211054959.Doi: 10.1177/15910199211054959.Epub ahead of print.Pmid: 34792425.Objective and methods: this article is a retrospective cohort study conducted from january 2016 to december 2018 in a single institution which reviewed records of patients who underwent stent-assisted coil embolization (sace) for unruptured intracranial aneurysms (uias) and received dual antiplatelet therapy (dapt) of either clopidogrel with aspirin or ticagrelor with aspirin to prevent thromboembolic events (tes).The purpose of the study is to compare the safety and efficacy of these dual antiplatelet therapy for these patients.A total of 153 patients underwent sace for uias, and enterprise stents were used on all of them.113 patients received clopidogrel plus aspirin (clopidogrel group) and 40 patients received ticagrelor plus aspirin (ticagrelor group).Dapt was started 7 days before embolization, continued for 3 months and then shifted to aspirin alone for 12 months.61 were male and 92 were female, with an average age of 54.45 to 56.39 ± 10.272 to 13.64 years old.No major hemorrhagic events were observed.In conclusion, ticagrelor in comparison with clopidogrel, can also reduce tes without increasing bleeding tendency for sace of uias.Ticagrelor combined with low-dose aspirin is a safe and effective alternative option for sace.Lot, model and catalog number are not available, but the suspected cerenovus device possibly associated with reported adverse events: enterprise stent.Other cerenovus devices that were also used in this study: none mentioned.Non-cerenovus devices that were also used in this study: none mentioned.Adverse event(s) and provided interventions: qty 10 - ischemic stroke (1 had early ischemic stroke, within 3 months of embolization and the location of stent deployment were all in the internal carotid artery; 9 had delayed ischemic stroke, after 3 months of the procedure).No intervention/treatment was mentioned in the article.No patient outcome was provided.Qty 2 - thrombosis (acute in-stent).No intervention/treatment was mentioned.No patient outcome was provided.Qty 13 - bleeding (minor - skin ecchymosis, epistaxis, hemorrhoid bleeding).No intervention/treatment was mentioned.No patient outcome was provided.

• 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): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15463366
• MDR Text Key: 300374722
• Report Number: 3008114965-2022-00617
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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: 09/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2022
• 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: 08/23/2022
• 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