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

Model Number UNKNOWN

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

Patient Problem Aneurysm (1708)

Event Type  Injury  

Manufacturer Narrative

The lot numbers were not provided; therefore, the device history records could not be reviewed and a lot history trending review could not be performed.The device was not returned to the manufacturer for analysis; therefore, the alleged product issue cannot be confirmed.If the device or additional information is received, microvention, inc., will submit a supplemental mdr report.Article bibliograph: cortese, jonathan, et al."determinants of cerebral aneurysm occlusion after embolization with the web device: a single-institution series of 215 cases with angiographic follow-up." journal of neurointerventional surgery (2022).

Event Description

As reported through the journal article titled, determinants of cerebral aneurysm occlusion after embolization with the web device: a single-institution series of 215 cases with angiographic follow-up" 70 patients with ruptured and unruptured aneurysms were treated with a web device (web-sl qty 32, web-dl qty 4, web-sls qty 8, fifth-generation web qty 26) between july 2012 and october 2021.All patients were observed to have developed aneurysm remnants during the angiographic follow-up period (3-97 months), of which 20 required retreatment because of the recurrence.

• Brand Name: WEB
• 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: 14253130
• MDR Text Key: 290453326
• Report Number: 2032493-2022-00179
• Device Sequence Number: 1
• Product Code: OPR
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P170032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/20/2022

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: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/20/2022
• Initial Date FDA Received: 04/29/2022
• 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): Other; Required Intervention