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 Problem Ischemia Stroke (4418)

Event Date 02/21/2023

Event Type  Injury  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).This complaint is from a literature source and the following citation was reviewed: ryu jc, bae jh, ha sh, kwon b, song y, lee dh, chang jy, kang dw, kwon su, kim js, kim bj.In-stent restenosis and stented-territory infarction after carotid and vertebrobasilar artery stenting.Bmc neurol.2023 feb 21;23(1):79.Doi: 10.1186/s12883-023-03110-z.Pmid: 36803229; pmcid: pmc9942307.Follow up was performed and authors provided information identifying one patient with enterprise stent who experienced the following: stented territory infarction (total of 56 included in the article) after right distal va stenting.Enterprise stent 4.5/28mm.No interventions required.Female, 28 years old patient, intracranial stenting for right distal va ~ ba dissection.After stenting, authors check f/u brain imaging, and found new ischemic lesion in the left medial thalamus.Patient had no symptoms about this lesion (asymptomatic).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.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: ryu jc, bae jh, ha sh, kwon b, song y, lee dh, chang jy, kang dw, kwon su, kim js, kim bj.In-stent restenosis and stented-territory infarction after carotid and vertebrobasilar artery stenting.Bmc neurol.2023 feb 21;23(1):79.Doi: 10.1186/s12883-023-03110-z.Pmid: 36803229; pmcid: pmc9942307.Background and purpose: background prognosis after vertebrobasilar stenting (vbs) may differ from that after carotid artery stenting (cas).Here, we directly compared the incidence and predictors of in-stent restenosis and stented-territory infarction after vbs and compared them with those of cas.Methods we enrolled patients who underwent vbs or cas.Clinical variables and procedure-related factors were obtained.During the 3 years of follow-up, in-stent restenosis and infarction were investigated in each group.In-stent restenosis was defined as reduction in the lumen diameter>50% compared with that after stenting.Factors associated with the occurrence of in-stent restenosis and stented-territory infarction in vbs and cas were compared.Results among 417 stent insertions (93 vbs and 324 cas), there was no statistical difference in in-stent restenosis between vbs and cas (12.9% vs.6.8%, p=0.092).However, stented-territory infarction was more frequently observed in vbs than in cas (22.6% vs.10.8%; p=0.006), especially a month after stent insertion.Hba1c level, clopidogrel resistance, and multiple stents in vbs and young age in cas increased the risk of in-stent restenosis.Diabetes (3.82 [1.24¿11.7]) and multiple stents (22.4 [2.4¿206.4]) were associated with stented-territory infarction in vbs.However, in-stent restenosis (odds ratio: 15.1, 95% confidence interval: 3.17¿72.2) was associated with stented-territory infarction in cas.Conclusions stented-territory infarction occurred more frequently in vbs, especially after the periprocedural period.In-stent restenosis was associated with stented-territory infarction after cas, but not in vbs.The mechanism of stented-territory infarction after vbs may be different from that after cas.Cerenovus devices that were used in this study: enterprise stents non-cerenovus devices that were also used in this study: wingspan stents (boston scientific), vision stents(abbott laboratories), protégé stents(covidien), precise stents(cordis), and acculink stents (abbott laboratories) quantities for each device not provided.The article provides insufficient information to associate adverse event(s) to specific device manufacturer.Exact product quantities cannot be accurately determined as patients can experience more than one adverse event.Adverse event(s) and provided interventions not identified to be associated with specific device manufacturer's device: qty 34 in-stent restenosis.Qty 56 infarction.

• 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: 17435765
• MDR Text Key: 320206490
• Report Number: 3008114965-2023-00552
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 08/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2023
• 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: 07/27/2023
• 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: ACCULINK STENTS (ABBOTT LABORATORIES); PRECISE STENTS(CORDIS); PROTÉGÉ STENTS(COVIDIEN); VISION STENTS(ABBOTT LABORATORIES); WINGSPAN STENTS (BOSTON SCIENTIFIC)
• Patient Outcome(s): Life Threatening