MAUDE Adverse Event Report: MICROVENTION, INC. WOVEN ENDOBRIDGE (WEB) ANEURYSM EMBOLIZATION SYSTEM; INTRASACCULAR FLOW DISRUPTION DEVICE

Model Number UNKNOWN

Device Problems Filling Problem (1233); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Aneurysm (1708); Thrombosis/Thrombus (4440)

Event Type  Injury  

Manufacturer Narrative

The lot number was not provided; therefore, a search for production-related ncrs could not be performed.The device was implanted in the patient and not available for return to the manufacturer for analysis.The investigation is ongoing.

Event Description

As reported through the article titled, "semi-automated cerebral aneurysm segmentation and geometric analysis for web sizing utilizing a cloud-based computational platform," persistent filling was found to be required in 4 patients that had been implanted with a web device (within the previous 15 months) for the treatment of their cerebral aneurysms.

Manufacturer Narrative

The device was not returned for evaluation; therefore, the product analysis could not be performed.

• Brand Name: WOVEN ENDOBRIDGE (WEB) ANEURYSM EMBOLIZATION SYSTEM
• Type of Device: INTRASACCULAR FLOW DISRUPTION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 11828709
• MDR Text Key: 250846263
• Report Number: 2032493-2021-00212
• Device Sequence Number: 1
• Product Code: OPR
• Combination Product (y/n): N
• PMA/PMN Number: P170023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 06/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2021
• 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
• Date Manufacturer Received: 05/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability