MAUDE Adverse Event Report: NEURAVI LTD. UNK_THROMBECTOMY NEURAVI; CATHETER, THROMBUS RETRIEVER

Catalog Number UNK_THROMBECTOMY NEURAVI

Device Problem Fracture (1260)

Patient Problems Vasoconstriction (2126); Perforation of Vessels (2135)

Event Type  Injury  

Event Description

This complaint is from a database related research activity (drra).On behalf of (b)(6), medtech epidemiology, please see the drra potential complaint form, aligned to a cerenovus product, and a copy of the final study report.Lot, model, and catalog number are not available, but the suspected cerenovous devices possibly associated with reported adverse events: unknown embotrap.This study dataset is a prospective clinical registry of consecutive stroke patients treated in a single center to assess embotrap¿s effectiveness, safety, and efficiency in treating acute ischemic stroke patients who have a large artery occlusion in their neurovascular.Device name: embotrap® revascularization device.The following adverse event occurred 6 hours after the procedure: ip-01669829: qty 1: internal carotid artery (ica) vasospasm.Qty 3: middle cerebral artery (mca) perforation.Qty 1: stent fracture.

Manufacturer Narrative

Product complaint # (b)(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.The initial reporter contact information is not available.The device manufacture date is not known as the device lot number is not available / not reported.Due to the nature of the complaint, the device (s) were not returned for analysis nor was the sterile lot numbers provided in order to conduct a lot history review.As a result, we are closing this investigation.If the complaint device is received in the future, we will reopen the complaint and perform the investigation as appropriate.Complications were assessed after recanalization, twenty-four post thrombectomy, less than six hours after the procedure, more than six hours after the procedure, and ninety days after the procedure.Since the severity of the reported events is unknown, and the relationship of the device to the reported events cannot be disassociated, the event will be conservatively reported to the fda with the classification of "serious injury".This report is being submitted pursuant to the provisions of 21 cfr, part 4.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.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.

• Brand Name: UNK_THROMBECTOMY NEURAVI
• Type of Device: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): NEURAVI LTD.; block 3 ballybritt; business park; galway H91 K 5YD; EI H91 K5YD
• Manufacturer (Section G): ADVANT MEDICAL; parkmore business park west; galway H91 P V0V; EI H91 PV0V
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 16511887
• MDR Text Key: 310956208
• Report Number: 3011370111-2023-00033
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K173452
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/15/2023

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_THROMBECTOMY NEURAVI
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/28/2023
• Initial Date FDA Received: 03/09/2023
• Supplement Dates Manufacturer Received: 03/14/2023
• Supplement Dates FDA Received: 03/15/2023
• 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