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 Restenosis (4576)

Event Date 05/01/2023

Event Type  Injury  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).This complaint is from a literature source and the following citation was reviewed: liu l, su x, zhang l, li z, bu k, yuan s, wang q, wang y, aime nj, liu z, zhou c, yu j, tan g, guo l, liu x.Cerebral collateral circulation as an independent predictor for in-stent restenosis after carotid artery stenting.Quant imaging med surg.2023 may 1;13(5):2941-2952.Doi: 10.21037/qims-22-975.Epub 2023 mar 8.Pmid: 37179948; pmcid: pmc10167455.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 h.4: the device manufacture date is not known as the device lot number is not available / not reported.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 type of occlusion is not specified and being coded as an arterial restenosis.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.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.

Event Description

This complaint is from a literature source and the following citation was reviewed: liu l, su x, zhang l, li z, bu k, yuan s, wang q, wang y, aime nj, liu z, zhou c, yu j, tan g, guo l, liu x.Cerebral collateral circulation as an independent predictor for in-stent restenosis after carotid artery stenting.Quant imaging med surg.2023 may 1;13(5):2941-2952.Doi: 10.21037/qims-22-975.Epub 2023 mar 8.Pmid: 37179948; pmcid: pmc10167455.Background and purpose: we aimed to evaluate the effect of cerebral collateral circulation on in-stent restenosis after carotid artery stenting and to establish a clinical prediction model for in-stent restenosis.This retrospective case-control study enrolled 296 patients with severe carotid artery stenosis of c1 segment (=70%) who underwent stent therapy from june 2015 to december 2018.Based on follow-up data, the patients were divided into the in-stent restenosis and no in-stent restenosis groups.The collateral circulation of the brain was graded according to the criteria of the american society for interventional and therapy neuroradiology/society for interventional radiology (asitn/sir).Clinical data were collected, such as age, sex, traditional vascular risk factors, blood cell count, high-sensitivity c-reactive protein, uric acid, stenosis degree before stenting and residual stenosis rate, and medication after stenting.Binary logistic regression analysis was performed to identify potential predictors of in-stent restenosis, and a clinical prediction model for in-stent restenosis after carotid artery stenting was established.Cerenovus devices that were used in this study: qty 47 : enterprise stents.Adverse event(s) and provided interventions associated with enterprise stent: qty 3 - in-stent restenosis.Treatments not listed.

• 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 ; 303552-689
• MDR Report Key: 18558138
• MDR Text Key: 333435924
• Report Number: 3008114965-2024-00106
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 01/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2024
• 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: 01/10/2024
• 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): Other