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 Transient Ischemic Attack (2109); Restenosis (4576)

Event Date 02/01/2021

Event Type  Injury  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).This complaint is from a literature source and the following citation was reviewed: shao q, li q, wu q, li t, li l, chang k.Comparison of 3d t1-space and dsa in evaluation of intracranial in-stent restenosis.Br j radiol.2021 feb 1;94(1118):20190950.Doi: 10.1259/bjr.20190950.Epub 2020 dec 1.Pmid: 33259233; pmcid: pmc7934295.The product catalog and lot numbers are not available / not reported.The unique identifier (udi) and expiration date of the device is not known.Initial reporter facility name: (b)(6).The initial reporter address line 1: facility address is not known / listed in article.The initial reporter address line 2: (b)(6).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.Stroke and ischemia is a known complication associated with the use of the enterprise and is mentioned in the instructions for use (ifu) as such.In addition, transient ischemic attack (tia) is one of the adverse events observed in a clinical study where patients were treated with this device (listed in ifu) and was possibly device/procedure related.Occlusion of the treated segment may also occur with the use of enterprise per its ifu.There is no mention of any device malfunction or performance issues in the article.However, the relationship between the reported events and the enterprise device cannot be excluded.Therefore, this event is considered serious and mdr reportable.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.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: shao q, li q, wu q, li t, li l, chang k.Comparison of 3d t1-space and dsa in evaluation of intracranial in-stent restenosis.Br j radiol.2021 feb 1;94(1118):20190950.Doi: 10.1259/bjr.20190950.Epub 2020 dec 1.Pmid: 33259233; pmcid: pmc7934295.Abstract: objective: in-stent restenosis (isr) after stenting for intracranial stenosis is a significant issue.This study aimed to evaluate the usefulness of the 3d t1-space technique in the follow-up of patients after stent implantation.Method(s): fifteen patients with intracranial arterial stenosis were prospectively enrolled 6-8 months after stenting.Digital subtraction angiography (dsa) and 3d t1-space imaging were performed to evaluate the degree of stenosis and the enhancement of the vessel wall.Bland-altman plots were used to assess the agreement between the two imaging methods, and the pearson correlation coefficient was calculated as a measure of the linear correlation.Result(s): eight enterprise stents and seven wingspan stents were used in 15 patients.The follow-up dsa after 6-8 months showed that the degree of stenosis was 40% (range, 30-72%), and isr occurred in 4 of 15 (26.7%) lesions.The degree of stenosis assessed using the 3d t1-space imaging technique was 35% (range, 30- 75%).All four patients with isr demonstrated significant enhancement.The pearson correlation coefficient between the two methods was 0.959 (p < 0.05), and the bland-altman plot showed that all data points were within the consistency limits (-x +/- 1.96 s).Conclusion(s): as a non-invasive imaging modality, 3d t1-space showed great consistency with dsa in measuring the degree of stenosis after intracranial stenting.It may be used as an optional method for detecting isr.Lot, model and catalog number are not available, but the suspected cerenovus device possibly associated with reported adverse events: enterprise stent.Other cerenovus devices that were also used in this study: n/a.Concomitant non-cerenovus devices that were also used in this study: wingspan stent.Adverse event(s) and provided interventions: qty 4 intracranial in-stent restenosis.The article does not provide sufficient information to determine which manufacturer's medical device is associated with the adverse events.

• 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15487887
• MDR Text Key: 300652443
• Report Number: 3008114965-2022-00627
• 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: 09/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2022
• 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: 08/30/2022
• 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: 3.0 T SIEMENS PRISMA MRI WTIH 64-CHANNEL COIL; WINGSPAN (BOSTON SCIENTIFIC); WINGSPAN STENT
• Patient Outcome(s): Life Threatening