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 Thromboembolism (2654)

Event Date 07/18/2011

Event Type  Injury  

Manufacturer Narrative

Manufacturer¿s ref.(b)(4).This complaint is from a literature source and the following citation was reviewed: lodi ym, latorre jg, el-zammar z, swarnkar a, deshaies e, fessler rd.Stent assisted coiling of the ruptured wide necked intracranial aneurysm.J neurointerv surg.2012 jul;4(4):281-6.Doi: 10.1136/neurintsurg-2011-010035.Epub 2011 jul 18.Pmid: 21990500.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: (b)(6).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 required a medical/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.

Event Description

This complaint is from a literature source and the following citation was reviewed: lodi ym, latorre jg, el-zammar z, swarnkar a, deshaies e, fessler rd.Stent assisted coiling of the ruptured wide necked intracranial aneurysm.J neurointerv surg.2012 jul;4(4):281-6.Doi: 10.1136/neurintsurg-2011-010035.Epub 2011 jul 18.Pmid: 21990500.Background and purpose: to report any potential complication associated with the use of both aspirin and clopidogrel in stent assisted coiling of ruptured wide necked intracranial aneurysms.S consecutive patients who underwent stent assisted coiling for ruptured wide necked intracranial aneurysm were enrolled from 2005 to 2009.Patients¿ demographics, including hunt and hess grade, fisher scale, and location and size of aneurysms, were collected.Complications such as rupture of aneurysm, thromboembolic events, ventriculostomy associated or systemic hemorrhages were recorded.Additionally, a 90 day outcome measurement was obtained using the glasgow outcome scale.Cerenovus devices that were used in this study: qty 2- enterprise stents adverse event(s) and provided interventions associated with enterprise stent: there were two episodes of stent thrombosis; one was an asymptomatic event which developed during the stent assisted coiling procedure and resolved spontaneously; the other was symptomatic which required intra-arterial administration of glycoprotein iibiiia receptor antagonist.

• 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: 18520225
• MDR Text Key: 332946815
• Report Number: 3008114965-2024-00069
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H60001
• 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?: 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: 01/03/2024
• 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): Life Threatening