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 Vasoconstriction (2126)

Event Date 12/13/2022

Event Type  Injury  

Event Description

This complaint is from a literature source and the following citation was reviewed: wu d, lai n, zhao x, liu j, li z, fang x.Enterprise 2 stent-assisted embolization of paraclinoid aneurysms: a single center preliminary study.Clin interv aging.2022 dec 13;17:1833-1840.Doi: 10.2147/cia.S390882.Pmid: 36536798; pmcid: pmc9759008.Purpose / objective / methods:objective: enterprise stent has been widely used for assisted embolization in wide-necked aneurysms while delayed ischemia or thromboembolic complications for its incomplete stent apposition.The purpose of this study was to summarize and analyze the clinical experience of using enterprise 2 (ep2) stent-assisted embolization in the treatment of paraclinoid aneurysms.Methods: from january 2019 to december 2020, the clinical and imaging data of 98 patients with paraclinoid aneurysms treated with ep2 stent-assisted embolization were enrolled retrospectively.Preliminary experience and follow-up outcomes of ep2 stent-assisted embolization of paraclinoid aneurysms were assessed by using the raymond grade and modified rankin scale.Results: of the 98 aneurysms, all stents were released satisfactorily.The immediate postprocedural angiography revealed a complete occlusion of the aneurysms with 77.55% of the (76/98) patients, and the last follow-up angiograms showed complete occlusion with 83.67% of the (82/98) patients.The average aneurysm size was (4.11 ± 1.25) mm, the aneurysm diameter was (4.41 ± 1.37) mm, the vessel radius was (3.87 ± 0.32) mm, the diameter at the distal of stent was (3.23 ± 0.21) mm, and the proximal was (4.18 ± 0.23) mm.Among the 98 aneurysms, 13 cases had incomplete stent apposition, 3 cases had intraoperative knotting, and the stents were improved post adjusted; 2 cases had vasospasm and 1 case had stenosis during operation, the symptoms were improved after symptomatic treatment.The result demonstrated that stent length and inner bending radius of parent artery were the pivotal factors affecting incomplete stent apposition (p < 0.01).Conclusion: the ep2 stent for the treatment of paraclinoid aneurysms is safe and effective, however, the length of the stent and the inner bending radius of parent artery are important factors affecting incomplete stent apposition.Lot, model and catalog number are not available, but the suspected cerenovus device possibly associated with reported adverse events: enterprise stent.Cerenovus devices that were used in this study: n/a.Non-cerenovus devices that were also used in this study: n/a.Device malfunctions without interventions possibly associated with unidentified enterprise stent: qty 13 incomplete stent apposition (migration).Qty 3 intraoperative knotting (kinked).Adverse event(s) and provided interventions possibly associated with unidentified enterprise stent: qty 2 vasospasm (arterial spasm) during procedure - article states treated but does not specify the treatment (considered serious).Qty 1 stenosis (arterial spasm) during procedure - article states treated but does not specify the treatment (considered serious).

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).This complaint is from a literature source and the following citation was reviewed: wu d, lai n, zhao x, liu j, li z, fang x.Enterprise 2 stent-assisted embolization of paraclinoid aneurysms: a single center preliminary study.Clin interv aging.2022 dec 13;17:1833-1840.Doi: 10.2147/cia.S390882.Pmid: 36536798; pmcid: pmc9759008.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 e.1: the initial reporter phone is not available / reported.Section h.4: the device manufacture date is not known as the device lot number is not available / not reported.Since the event is life threatening and it might result in permanent impairment of a body function or permanent damage to a body structure; or it could require medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious.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.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.

• 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: 17312547
• MDR Text Key: 319006934
• Report Number: 3008114965-2023-00499
• 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: 07/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2023
• 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: 06/28/2023
• 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
• Patient Outcome(s): Life Threatening