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

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

Patient Problems Aneurysm (1708); Hemorrhage/Bleeding (1888); Perforation of Vessels (2135); Cerebral Edema (4403); Ischemia Stroke (4418); Thrombosis/Thrombus (4440)

Event Type  Injury  

Manufacturer Narrative

The device lot number was not provided; therefore, a device history record and non-conformances could not be performed.The device remains impanted in the patient; therefore, the alleged product issue cannot be confirmed.The instructions for use (ifu) identifies aneurysm perforation or rupture, hemorrhage, edema, ischemic stroke, neurologic deficits, vessel dissection or perforation, as potential complications associated with use of the device.

Event Description

As reported through the article titled, "stent-assisted web embolization: aneurysm characteristics, outcome and case report of a web delivered through a stent," a retrospective, multi-center analysis of patients that were treated with the web between january 2011 and october 2020 was performed.A total of 163 aneurysms were treated by web only and 15 were treated with stent-assistance.Of those 163 treatments performed, procedural complications included 18 thromboembolic and 3 hemorrhagic events.In most cases, the thrombus could be resolved with tirofban or acetylsalicylic acid and/or the patient had asymptomatic (silent) infarction.Hence, symptomatic thromboembolic events (ischemic stroke) were not significantly different.In the stent assisted web embolization group, 3 of 5 thromboembolic events occurred due to web protrusion into the parent artery and 2 were related to stent-implantation.There was one neurological complication related to stent assisted web embolization.After web placement in an unruptured acom aneurysm, the web protruded into the parent vessel requiring additional stent implantation.After the procedure, the patient showed transient aphasia and a mild hemiparesis on the right.Emergency ct showed vasogenic oedema around the acom aneurysm, but there was no infarction.The patient recovered fully.There were 3 neurological complications in the web only group, including 2 ischemic strokes and 1 hemorrhagic events (rupture of a perforating artery).Angiographic results among the web only patients showed 28 neck remnants and 57 aneurysm remnants.Results for the web plus stent patients showed 3 neck remnants and 3 aneurysm remnants.Repeat angiographic images performed during the 6month follow-up period for the web only group showed 24 neck remnants and 9 aneurysm remnant for the web only group.The web plus sent group showed 3 neck remnants and 2 aneurysm remnants.It was also noted that ten patients had been retreated, 9 after web implantation only and 1 after stent-assisted web embolization.

• 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: 13563321
• MDR Text Key: 286512547
• Report Number: 2032493-2022-00065
• Device Sequence Number: 1
• Product Code: OPR
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P170032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2022
• 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