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 Perforation of Vessels (2135); Thromboembolism (2654); Restenosis (4576); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/16/2010

Event Type  Injury  

Event Description

This complaint is from a literature source and the following citation was reviewed: a.Wakhloo, a.Gounis, e.Segal.(2010).Stent assisted coil embolization with the enterprise vascular reconstruction device: mid term clinical and angiographic results.J neurointervent surg.(2)1.Doi:10.1136/jnis.2010.003236.16.Background and purpose: we evaluate the safety and efficacy of the enterprise stent at our center.Cerenovus devices that were used in this study: qty unk: enterprise stent.Adverse event(s) and provided interventions associated with the enterprise stent: qty 13: intra-operative thromboembolic complications that were successfully treated with intra-arterial thrombolytics (tissue plasminogen activator and abciximab).Qty 1: there was one case of acute stent migration during the treatment of a basilar tip aneurysm.Qty 1: intraoperative aneurysm perforation.Qty 2: in-stent stenosis during follow-up.Qty 6: cases of delayed thromboembolic complications.Treatments not listed.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).This complaint is from a literature source and the following citation was reviewed: a.Wakhloo, a.Gounis, e.Segal.(2010).Stent assisted coil embolization with the enterprise vascular reconstruction device: mid term clinical and angiographic results.J neurointervent surg.(2)1.Doi:10.1136/jnis.2010.003236.16.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.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: 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: 18522521
• MDR Text Key: 332974805
• Report Number: 3008114965-2024-00073
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2024
• Is this an Adverse Event Report?: Yes
• 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: 01/05/2024
• 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): Required Intervention; Life Threatening