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 Thromboembolism (2654); Restenosis (4576)

Event Date 12/02/2023

Event Type  Injury  

Event Description

This complaint is from a literature source and the following citation was reviewed:goertz l, zopfs d, pennig l, zaeske c, timmer m, turowski b, kaschner m, borggrefe j, schönfeld m, schlamann m, kabbasch c.Comparative analysis of the low-profile acclino stent and the enterprise stent for the treatment of unruptured intracranial aneurysms.World neurosurg.2023 dec 2:s1878-8750(23)01702-3.Doi: 10.1016/j.Wneu.2023.11.138.Epub ahead of print.Pmid: 38043742.Objective/methods/study data: objective:this dual-center study is a head-to-head comparison of the low-profile acandis acclino stent (a third-generation stent) and the firstand second-generation enterprise stent.Methods: patients who underwent stent-assisted coiling with either the enterprise or the acclino stent for unruptured aneurysms during an 8-year period were enrolled and compared for complications, clinical outcomes, and angiographic results.Primary outcome measures were ischemic stroke rate and mid-term complete occlusion rate.Propensity score adjustment was performed to account for small differences between the groups.Results: enterprise and acclino stents were used in 48 cases each.The overall rate of thrombotic complications was higher in the enterprise group than in the acclino group (20.8% vs.4.2%, hr: 6.6, 95%ci: 2.2-20.0, p=0.01, adjusted p<0.01), which translated into a higher rate of major ischemic stroke after enterprise treatment (6.3% vs.0%, hr: 2.1, 95%ci: 1.8-2.4, p=0.08, adjusted p<0.01).Mid-term and long-term angiographic follow-up showed complete occlusion rates of 83.3% and 75.0% for enterprise and 89.2% and 75.9% for acclino (both p>0.05).Retreatment rates were 10.4% in the enterprise group and 4.2% in the acclino group (p=0.42, adjusted p=0.10).Lot, model and catalog number are not available, but the suspected cerenovus device possibly associated with reported adverse events: enterprise stent.Adverse event(s) and provided interventions possibly associated with unidentified enterprise stent: qty 3 major ischemic stroke caused periprocedurally by a thromboembolic event (recognized procedural complication, thromboembolism) qty 1 in-stent thromboembolism (recognized procedural complication, arterial re-stenosis).

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).This complaint is from a literature source and the following citation was reviewed:goertz l, zopfs d, pennig l, zaeske c, timmer m, turowski b, kaschner m, borggrefe j, schönfeld m, schlamann m, kabbasch c.Comparative analysis of the low-profile acclino stent and the enterprise stent for the treatment of unruptured intracranial aneurysms.World neurosurg.2023 dec 2:s1878-8750(23)01702-3.Doi: 10.1016/j.Wneu.2023.11.138.Epub ahead of print.Pmid: 38043742.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 phone: 0049 221 478 82735.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: 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: 18567574
• MDR Text Key: 333537164
• Report Number: 3008114965-2024-00119
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 01/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2024
• 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: 01/17/2024
• 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