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 Restenosis (4576)

Event Date 04/07/2022

Event Type  Injury  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).This complaint is from a literature source and the following citation was reviewed: ari o, nas of, inecikli mf, hakyemez b.The effectiveness of enterprise stent use on the treatment of intracranial atherosclerosis disease.Neuroradiol j.2022 oct;35(5):612-618.Doi: 10.1177/19714009221083143.Epub 2022 apr 7.Pmid: 35392732; pmcid: pmc9513921.Although no specific intervention is stated, it is clinically reasonable to assume an intervention would be provided in the case of an occlusion at/near the stent site.The event is being reported to the us fda as a conservative measure.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.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: ari o, nas of, inecikli mf, hakyemez b.The effectiveness of enterprise stent use on the treatment of intracranial atherosclerosis disease.Neuroradiol j.2022 oct;35(5):612-618.Doi: 10.1177/19714009221083143.Epub 2022 apr 7.Pmid: 35392732; pmcid: pmc9513921.Background and purpose: to examine the clinical outcome of enterprise stent in patients with severe and symptomatic intracranial atherosclerosis.Twenty-five patients who underwent enterprise stenting between january 2012 and march 2019 were included in this study.Exclusion criteria were previous intracranial stenting and inadequate follow-up.Technical success rates of the procedures were recorded.Clinical outcome was evaluated with pre- and post-treatment modified rankin scale scores.The patients were monitored for 18 months clinically and for 14.3 months radiologically.Cerenovus devices that were used in this study: qty 25: enterprise stents.Adverse event(s) and provided interventions associated with the enterprise stent: case # 2: patient had intra-stent restenosis.Presented with severe dizziness.Treatment not listed.(another patient also had intra-stent stenosis, however, this was attributed to an unusual anticoagulation medication resistance.Therefore, this patient was not included).

• 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: 18522411
• MDR Text Key: 332975053
• Report Number: 3008114965-2024-00072
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: TU
• 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: 01/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2024
• 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: 01/09/2024
• 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
• Patient Age: 79 YR
• Patient Sex: Male