MAUDE Adverse Event Report: MICROVENTION, INC. WEB SL 21 SINGLE LAYER; INTRASACCULAR FLOW DISRUPTION DEVICE

Model Number W4-7-4-MVI-3

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

Patient Problems Stroke/CVA (1770); Hematoma (1884); Vomiting (2144); Obstruction/Occlusion (2422); Confusion/ Disorientation (2553); Thrombosis/Thrombus (4440)

Event Date 01/14/2021

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 implanted in the patient and was not returned to the manufacturer for evaluation.Additionally, procedural images were not provided; therefore, the reported event cannot be confirmed.The instructions for use (ifu) identifies neurological deficits, parent artery occlusion, thromboemboli, and ischemic stroke as potential complications associated with use of the device.

Event Description

It was reported that an unruptured anterior communicating artery (aca) aneurysm was treated with a web device.The device was implanted with no issues, and control angiograms showed no flow delay in the either aca.An anterior frontal m3 branch was then found to be occluded.Intra-arterial tpa 4mg was administered and a stent retriever were used, and recanalization was achieved.The patient had not been heparinized for 20 minutes during implantation of the device as the act machine was broken and a new one had to be retrieved.7 hours post-procedure, the patient vomited and was confused.A ct showed a left frontal hematoma, caused by the ia tpa and microwire manipulation, and also indication of bilateral distal aca stroke.It is the physician's opinion that the clot in the m3 was most likely not associated with the web device, but the that the bilateral aca strokes were most likely caused by micro-emboli from the proximal surface of the device.It was related that the patient is now in a long term acute care facility and has "resumed modified oral diet and has started saying a few words.Still is dependent on nursing care for activities of daily living.".

• Brand Name: WEB SL 21 SINGLE LAYER
• Type of Device: INTRASACCULAR FLOW DISRUPTION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: eva manus ; 35 enterprise drive; aliso viejo, CA 92656
• MDR Report Key: 11509913
• MDR Text Key: 240663216
• Report Number: 2032493-2021-00074
• Device Sequence Number: 1
• Product Code: OPR
• UDI-Device Identifier: 00842429107096
• UDI-Public: (01)00842429107096(11)200824(17)250731(10)200824137
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P170032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: W4-7-4-MVI-3
• Device Catalogue Number: W4-7-4
• Device Lot Number: 200824137
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2020
• 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): Disability
• Patient Age: 58 YR