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 Intracranial Hemorrhage (1891)

Event Date 12/22/2015

Event Type  Injury  

Event Description

This complaint is from a literature source and the following citation was reviewed: da ros v, meschini a, gandini r, del giudice c, garaci f, stanzione p, rizzato b, diomedi m, simonetti g, floris r, sallustio f.Proposal for a vascular computed tomography-based grading system in posterior circulation stroke: a single-center experience.J stroke cerebrovasc dis.2016 feb;25(2):368-77.Doi: 10.1016/j.Jstrokecerebrovasdis.2015.10.008.Epub 2015 dec 22.Pmid: 26725261.Objective and methods: the aim of this retrospective study is to investigate the role of a computed tomography angiography (cta)-based approach in patients undergoing mechanical thrombectomy for vertebrobasilar stroke treatment.Lot, model, and catalog number are not available, but the suspected cerenovus device is possibly associated with reported adverse events: revive device 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: three patients (20%) presented postprocedural symptomatic intracranial hemorrhage and all of them experienced an unsuccessful recanalization.Of these three patients, two of them underwent mechanical thrombectomy using the revive device.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).This complaint is from a literature source and the following citation was reviewed: da ros v, meschini a, gandini r, del giudice c, garaci f, stanzione p, rizzato b, diomedi m, simonetti g, floris r, sallustio f.Proposal for a vascular computed tomography-based grading system in posterior circulation stroke: a single-center experience.J stroke cerebrovasc dis.2016 feb;25(2):368-77.Doi: 10.1016/j.Jstrokecerebrovasdis.2015.10.008.Epub 2015 dec 22.Pmid: 26725261.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 e.1: initial reporter address line 2: department of diagnostic imaging and interventional radiology.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.

• 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: 16924226
• MDR Text Key: 315175107
• Report Number: 3008114965-2023-00292
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 05/05/2023
• 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