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

Catalog Number UNKENTERPRISE2

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)

Patient Problems Stroke/CVA (1770); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/31/2023

Event Type  malfunction  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).This complaint is from a literature source and the following citation was reviewed: gu w, zhou g, aldiyarova a, liu t, zhang y, liu w, meng l, gu b, li m, su m, su c, liu a, wang w.Stent-assisted coiling of intracranial carotid ophthalmic segment aneurysm segment aneurysms: long-term follow-up from a single center.J interv med.2023 jul 31;6(3):116-120.Doi: 10.1016/j.Jimed.2023.07.004.Pmid: 37846339; pmcid: pmc10577061.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.There is insufficient information within the text of this article to identify which devices(s) (cerenovus or non cerenovus) are associated with the reported adverse events.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 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: gu w, zhou g, aldiyarova a, liu t, zhang y, liu w, meng l, gu b, li m, su m, su c, liu a, wang w.Stent-assisted coiling of intracranial carotid ophthalmic segment aneurysm segment aneurysms: long-term follow-up from a single center.J interv med.2023 jul 31;6(3):116-120.Doi: 10.1016/j.Jimed.2023.07.004.Pmid: 37846339; pmcid: pmc10577061.Background and purpose: to evaluate the efficacy of stent-assisted coiling (sac) for the treatment of carotid ophthalmic segment aneurysm segment aneurysms (osas) of the internal carotid artery (ica) through detailed long-term follow-up of a large patient cohort.We retrospectively analyzed 88 consecutive patients with osas between (b)(6) 2009 and (b)(6) 2020 at our center.Angiographic results were evaluated using the modified raymond grading system and clinical outcomes were evaluated using the mrs scale.The primary endpoints were major aneurysm recurrence and poor clinical outcomes for at least 18 months of follow-up.The patients were asked to attend clinical follow-up assessments and possibly undergo dsa or mr via telephone.Cerenovus devices that were used in this study: qty unk: enterprise stents non-cerenovus devices that were also used in this study: qty unk: gdc detachable coils (stryker neurovascular); helicoil, microplex, and hydrocoil coils (microvention inc.); nexus and axium coils (ev3); neuroform stents (stryker neurovascular); , solataire ab stents (ev3); echelon 10 microcatheter (ev3); excelsior sl-10 microcatheter (stryker neurovascular).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: (b)(4): stent migration was encountered in three patients without clinical sequelae.(b)(4): post-interventional ischemic events developed in three patients after sac.(b)(4): coil migration (treatment failure).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: 18608233
• MDR Text Key: 335091336
• Report Number: 3008114965-2024-00152
• 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: 01/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: AXIUM¿ EMBOLIC COILS (EV3); ECHELON 10¿ MICROCATHETER (MEDTRONIC); EXCELSIOR SL-10® MICROCATHETER (STRYKER); GDC¿ DETACHABLE COILS (STRYKER); HELICOIL¿ EMBOLIC COILS (MICROVENTION); HYDROCOIL¿ EMBOLIC COILS (MICROVENTION); MICROPLEX¿ EMBOLIC COILS (MICROVENTION); NEUROFORM¿ STENT SYSTEM (STRYKER); NEXUS¿ EMBOLIC COILS (EV3); SOLITAIRE AB¿ STENT SYSTEM (EV3)