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 Problems Aneurysm (1708); Stroke/CVA (1770); Perforation (2001); Thromboembolism (2654); Vascular Dissection (3160)

Event Type  Injury  

Manufacturer Narrative

The device lot numbers are unknown; therefore, a search for non-conformances associated with the actual part/lot number combinations could not be performed.The devices were implanted in the patient and not returned to the manufacturer for analysis.Additionally, procedural images were not provided; therefore, the reported event cannot be confirmed.The instructions for use identify thromboemboli, device migration, vessel dissection, and neurological deficits as potential complications associated with use of the device.

Event Description

As reported through the article titled, "influence of operator experience on the technical and clinical results of woven endobridge endovascular treatment for intracranial aneurysms" web-related complications occurred in 28 patients that underwent web treatment for an intracranial aneurysm from (b)(6) 2014 to (b)(6) 2020.The most common complication was thrombo-embolism (n = 19); while the other complications were as follows: rebleeding (n=2), artery dissection (n=2), perforation (n=1) and web migration (n=1).For seven patients, complications were associated with new-onset neurological deficits, which were transient in four cases and persistent in three.Complications were intraprocedural in nine patients (seven thrombo-embolic events, one perforation and one dissection).Additionally, there were 25 occurrences of raymond-roy 3 aneurysm remnant occlusions.

• 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: 12510966
• MDR Text Key: 272972414
• Report Number: 2032493-2021-00385
• 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,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2021
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2021
• 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; Disability