MAUDE Adverse Event Report: MICROVENTION, INC. WEB SL; INTRASACCULAR FLOW DISRUPTION DEVICE

Model Number MV-WB060321

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

Patient Problem Ischemia Stroke (4418)

Event Date 12/18/2021

Event Type  Injury  

Manufacturer Narrative

A search for non-conformances associated with the reported part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The device was implanted in the patient and thus could not be returned to the manufacturer for evaluation.Fluoroscopic media was not provided.The event could not be confirmed.The instructions for use (ifu) identifies ischemic stroke as a potential complication associated with use of the device.

Event Description

It was reported that on (b)(6) 2021 a web device was implanted in an unruptured cerebral aneurysm at the bifurcation of the right internal carotid artery (ic-top).On (b)(6) 2021 cerebral infarction occurred on the same side as the aneurysm, in a perforating branch of the right middle cerebral artery (nhiss score of 1).Edaravone and argatroban were administered.On (b)(6) the patient's condition had improved (nihss: score of 0, mrs score of 0).Both clopidogrel and aspirin were administered.There was no device malfunction reported and the cause of the infarction was stated to be unknown.As of (b)(6) 2021, the patient was reported to be "well.".

• Brand Name: WEB SL
• Type of Device: INTRASACCULAR FLOW DISRUPTION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 13409482
• MDR Text Key: 284818075
• Report Number: 2032493-2022-00041
• Device Sequence Number: 1
• Product Code: OPR
• UDI-Device Identifier: 04987892122330
• UDI-Public: (01)04987892122330(11)210111(17)251231(10)210111128
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P170032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/06/2022

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 Model Number: MV-WB060321
• Device Lot Number: 210111128
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/06/2022
• Initial Date FDA Received: 02/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2021
• 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): Other; Required Intervention