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 Problem Embolism/Embolus (4438)

Event Date 01/01/2022

Event Type  Injury  

Event Description

This complaint is from a literature source and the following citation was reviewed: kuhn a, singh j, massari f, et ale-072 safety, efficacy and occlusion rates for embolization of very small and small aneurysms using a single coil journal of neurointerventional surgery 2022;14:a114.Objective and methods: the aim of this retrospective study was to challenge the concept of aneurysm packing density and the need for multiple coils to achieve aneurysm obliteration in aneurysms ten (10) mm.A neuro-interventional database was reviewed between january 2017 and december 2021, which identified all patients who underwent coil embolization for treatment of ruptured or unruptured intracranial 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: one (1) patient showed acute clot formation in a downstream vessel, which was successfully removed.Another patient showed sub occlusive clot in the internal carotid artery (ica) that was dislodged from a previously treated aneurysm due to catheter manipulation along the neck of that previously treated aneurysm.The clot was nearly completely resolved upon completion of the procedure.

Manufacturer Narrative

Manufacturer¿s ref.No: pc-(b)(4).This complaint is from a literature source and the following citation was reviewed: kuhn a, singh j, massari f, et ale-072 safety, efficacy and occlusion rates for embolization of very small and small aneurysms using a single coil journal of neurointerventional surgery 2022;14:a114.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.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.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: 16792277
• MDR Text Key: 313806325
• Report Number: 3008114965-2023-00258
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H160002
• 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: 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