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 Aneurysm (1708); Intracranial Hemorrhage (1891); Ischemia Stroke (4418)

Event Date 11/09/2020

Event Type  Injury  

Event Description

This complaint is from a literature source and the following citation was reviewed: kato n, nishimura k, sonoda s, kakizaki s, nagayama g, aoki k, maruyama f, ikemura a, kan i, kodama t, kaku s, yuki i, ishibashi t, otani k, murayama y.Comparison of clinical outcomes after stent-assisted coiling with 3 types of self-expanding laser-cut stents in patients with wide-necked intracranial aneurysms.World neurosurg.2021 feb;146:e701-e707.Doi: 10.1016/j.Wneu.2020.10.166.Epub 2020 nov 9.Pmid: 33181375.Background and purpose: we report the clinical outcomes of stent assisted coiling for wide-necked intracranial aneurysms using 3 low-profile laser-cut stents and compare the results according to stent type.Methods: all patients treated with stent-assisted coiling for their intracranial aneurysms at our hospital between july 2010 and september 2019 were reviewed.We selected patients with enterprise, neuroform ez, or neuroform atlas stents who underwent imaging follow-up and investigated aneurysm and stent features, stent-related complications, recanalization, and retreatment rates.We compared the retreatment risk among the patients treated with the 3 stent types using kaplan-meier survival analysis and cox regression analysis.Cerenovus devices that were used in this study: qty unk: (more than 1 stent can be used in one patient) enterprise 1 or enterprise 2 stents used in 103 cases non-cerenovus devices that were also used in this study: qty unk: neuroform ez (stryker).Exact product quantities cannot be accurately determined as patients can experience more than one adverse event.Adverse event(s) and provided interventions : enterprise 1 or 2 stents: qty 5: five patients experienced a cerebral infarction.Qty 1: one patient experienced an intracranial hemorrhage.Qty 1: one patient experienced coil entrapment.Treatments are not listed.Qty 19: nineteen patients experienced recanalization.Qty 11: eleven patients required retreatment.

Manufacturer Narrative

Product complaint #: (b)(4).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 e1.Initial reporter phone: (b)(6).H.4: 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.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.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.

• 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 ; 3035526892
• MDR Report Key: 18038750
• MDR Text Key: 326963462
• Report Number: 3008114965-2023-00789
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2023
• 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: 10/16/2023
• 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
• Treatment: NEUROFORM ATLAS (STRYKER); NEUROFORM EZ (STRYKER)
• Patient Outcome(s): Life Threatening; Required Intervention