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 Problems Visual Impairment (2138); Ischemia Stroke (4418)

Event Date 02/08/2021

Event Type  Injury  

Manufacturer Narrative

A search for non-conformances associated with this 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 discarded at the user facility.Additionally, procedural and post procedural images were not provided; therefore, the reported event cannot be confirmed.The instructions for use identifies ischemic stroke as a potential complication associated with use of the device.

Event Description

It was reported that a web device was attempted to be implanted in a basilar tip aneurysm, but the physician felt that the size of the web device was not suitable for the aneurysm and withdrew it without incident.A device from another manufacturer was used to complete the procedure.After the procedure, the patient experienced ipsilateral cerebral infarction and continuous heparin infusion was administrated.The patient's condition was reported to be "serious" and they are experiencing sequela.The physician commented that neither the web device nor the competitor's device could be ruled out as the cause of the infarction.

Manufacturer Narrative

Additional information received.The patient experienced temporary visual field loss, but recovered.The physician had believed the web's relationship to the event cannot be ruled out when the complaint first reported; however, later the physician denied the web's relationship to the event.H6: additional codes.

• Brand Name: WEB SL
• Type of Device: INTRASACCULAR FLOW DISRUPTION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 11683318
• MDR Text Key: 246022047
• Report Number: 2032493-2021-00142
• Device Sequence Number: 1
• Product Code: OPR
• UDI-Device Identifier: 04987892122330
• UDI-Public: (01)04987892122330(11)200910(17)230831(10)20091011B
• Combination Product (y/n): N
• PMA/PMN Number: P170032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: MV-WB060321
• Device Lot Number: 20091011B
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention