MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL UNKPULSERIDER; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number UNKPULSERIDER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Thromboembolism (2654); Unspecified Nervous System Problem (4426)

Event Date 01/01/2022

Event Type  Injury  

Event Description

This complaint is from a literature source and the following citation was reviewed: omodaka, s., matsumoto, y., & tominaga, t.(2022).P1-52 comparison of pulserider- vs conventional stent-assisted embolization for bifurcation aneurysms.Interventional neuroradiology, 28.Https://doi.Org/https://doi.Org/10.1177/15910199221142492.Objective and methods: the object of this study is to compare the 6-month results of pulserider-assisted embolization (pac) vs single stent-assisted embolization (sac) for intracranial unruptured bifurcation aneurysms.Lot, model, and catalog number are not available, but the suspected cerenovus device is possibly associated with reported adverse events: pulserider.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: the neurologic thromboembolic complication rate was 0% in pac and 5% in single sac.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).This complaint is from a literature source and the following citation was reviewed: omodaka, s., matsumoto, y., & tominaga, t.(2022).P1-52 comparison of pulserider- vs conventional stent-assisted embolization for bifurcation aneurysms.Interventional neuroradiology, 28.Https://doi.Org/https://doi.Org/10.1177/15910199221142492.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 and email address is not available.Section h.4: the device manufacture date is not known as the device lot number is not available / not reported.The complaint will be updated with any additional information received from performing follow-up activity with the corresponding author, and reportability will be reassessed if cerenovus devices are identified in association with any adverse events.As the events being reported required medical/surgical 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: UNKPULSERIDER
• 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): CODMAN & SHURTLEFF, INC. (FREMONT); 47709 fremont blvd; fremont CA 94538
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 303552-689
• MDR Report Key: 16792316
• MDR Text Key: 313804835
• Report Number: 3008114965-2023-00259
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: H160002
• 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: 04/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKPULSERIDER
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/17/2023
• 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): Required Intervention