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 Intracranial Hemorrhage (1891); Swelling/ Edema (4577)

Event Date 06/01/2022

Event Type  Injury  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).This complaint is from a literature source and the following citation was reviewed: yi, x., tao , j., lei , l., & quanbin , z.(2022).Efficacy of enterprise stent for revascularization of intracranial atherosclerosis stenosis induced acute large vessel occlusion.Journal of tongji university (medical science) , 43(3).Https://doi.Org/10.12289/j.Issn.1008-0392.22066.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.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.It was reported in a literature article that the following adverse events occurred: four (4) patients developed intracranial hemorrhage, and four (4) patients developed intercranial edema, all requiring additional surgical intervention.As the events being reported required medical/surgical intervention or prolonged hospitalization for treatment or prevention of permanent damage to the patient, this event is mdr reportable.The complaint will be updated with any additional information received from performing follow-up activity with the corresponding author, and reportability will be reassessed if cerenovus devices are identified in association with any adverse events.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: yi, x., tao , j., lei , l., & quanbin , z.(2022).Efficacy of enterprise stent for revascularization of intracranial atherosclerosis stenosis induced acute large vessel occlusion.Journal of tongji university (medical science) , 43(3).Https://doi.Org/10.12289/j.Issn.1008-0392.22066.Objective and methods: the objective of this study was to explore the safety and efficacy of the enterprise stent in the treatment of intracranial atherosclerosis stenosis induced by acute large vessel occlusion (icas-lvo).The data of 58 consecutive patients diagnosed with icas-lvo, who underwent endovascular treatment by enterprise implantation from january 2020 to september 2021 were retrospectively analyzed.Lot, model, and catalog number are not available, but the suspected cerenovus device is possibly associated with reported adverse events: enterprise other cerenovus devices that were also used in this study: prowler non-cerenovus devices that were also used in this study: n/a.Adverse event(s) and provided interventions: four (4) patients developed intracranial hemorrhage, and four (4) patients developed intercranial edema, all requiring additional surgical intervention.

• 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 303552-689
• MDR Report Key: 16109548
• MDR Text Key: 306784696
• Report Number: 3008114965-2023-00009
• 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: 01/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 12/13/2022
• Initial Date FDA Received: 01/05/2023
• 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): Required Intervention; Life Threatening