MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL UNKENTERPRISE2; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number UNKENTERPRISE2

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Ischemia Stroke (4418)

Event Date 08/10/2023

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).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.E.1: the initial reporter occupation, phone, fax, and e-mail address, was not reported.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.Clinician assessment: since the events are life-threatening with the potential to result in permanent impairment of a body function or permanent damage to a body structure and they potentially could have required medical/surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious.The events are reportable to the us fda.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 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.

Event Description

This complaint is from a literature source and the following citation was reviewed: nakajo t, terada t, tsumoto t, matsuda y, matsumoto h, nakayama s, mizutani t.Stent-assisted coil embolization of ruptured aneurysms in the acute stage: advantages and disadvantages.J neuroendovasc ther.2023;17(10):209-216.Doi: 10.5797/jnet.Oa.2023-0028.Epub 2023 aug 10.Pmid: 37869486; pmcid: pmc10586883.Objective and methods: this study aimed to evaluate the outcomes of coil embolization with stenting for ruptured cerebral aneurysms in the acute stage.Twenty (22) cases were treated with stenting among 134 of 169 consecutive patients with subarachnoid hemorrhages undergoing an endovascular treatment between april 2014 and december 2021, of which 134 underwent an embolization during the acute stage.A stent was used in the patients wherein the treatment with the balloon-assisted or double catheter technique was difficult.Stenting was performed under the loading of two or more antiplatelet agents.Lot, model, and catalog number are not available, but the suspected cerenovus device is possibly associated with reported adverse events: enterprise 2.Other concomitant cerenovus devices that were also used in this study: enterprise vrd non-cerenovus devices that were also used in this study: neuroform ez (stryker), nf atlas (stryker).Adverse event(s) and provided interventions: case #4: an 86-year-old female patient with a type d aneurysm in the middle cerebral artery (mca) who was treated with an enterprise2 stent experienced a stent-related ischemic complication-related stent with a decrease in mrs of one or more.Case #5: a 77-year-old male patient with a type s aneurysm in the vertebral artery (va) who was treated with an enterprise2 stent experienced a stent-related ischemic complication-related stent with imaging findings only.Case #7: a 45-year-old male patient with a type s aneurysm in the middle cerebral artery (mca) who was treated with two enterprise2 stents experienced a stent occlusion and a stent-related ischemic complication-related stent with a decrease in mrs of one or more.Case #18: an 89-year-old female patient with a type f aneurysm in the internal carotid and posterior cerebral artery (ica-pca) who was treated with an enterprise2 stent experienced a stent-related ischemic complication related stent with a decrease in mrs of one or more.

• Brand Name: UNKENTERPRISE2
• 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: 18645759
• MDR Text Key: 334620421
• Report Number: 3008114965-2024-00188
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 02/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKENTERPRISE2
• 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
• Treatment: NEUROFORM EZ (STRYKER); NF ATLAS (STRYKER)
• Patient Outcome(s): Life Threatening
• Patient Age: 45 YR