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 Problems Thromboembolism (2654); Ischemia Stroke (4418)

Event Date 07/31/2012

Event Type  Injury  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).This complaint is from a literature source and the following citation was reviewed: dávalos a, pereira vm, chapot r, bonafé a, andersson t, gralla j; solitaire group.Retrospective multicenter study of solitaire fr for revascularization in the treatment of acute ischemic stroke.Stroke.2012 oct;43(10):2699-705.Doi: 10.1161/strokeaha.112.663328.Epub 2012 jul 31.Pmid: 22851547.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 this event required medical intervention or prolonged hospitalization for treatment or prevention of permanent damage to the patient, this event is mdr reportable.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: dávalos a, pereira vm, chapot r, bonafé a, andersson t, gralla j; solitaire group.Retrospective multicenter study of solitaire fr for revascularization in the treatment of acute ischemic stroke.Stroke.2012 oct;43(10):2699-705.Doi: 10.1161/strokeaha.112.663328.Epub 2012 jul 31.Pmid: 22851547.Objective and methods: the purpose of this retrospective study was to evaluate the safety and efficacy of the solitaire fr device in the treatment of patients with acute ischemic stroke secondary to large artery occlusion.Lot, model, and catalog number are not available, but the suspected cerenovus device is possibly associated with reported adverse events: enterprise.Other concomitant cerenovus devices that were also used in this study: n/a.Non-cerenovus devices that were also used in this study: n/a.Adverse event(s) and provided interventions: one patient experienced cerebral ischemia after intrastent thrombosis of the enterprise stent placed to treat the dissection.

• 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: 16923410
• MDR Text Key: 315181940
• Report Number: 3008114965-2023-00291
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 05/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 05/04/2023
• Initial Date FDA Received: 05/12/2023
• 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