MAUDE Adverse Event Report: MICROVENTION, INC. WEB 17; INTRASACCULAR FLOW DISRUPTION DEVICE

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

Patient Problems Aneurysm (1708); Ruptured Aneurysm (4436)

Event Type  Injury  

Event Description

As reported through the journal article titled "intracranial aneurysm treatment with intrasaccular flow disruption: comparison of web-21 and web 17 systems", from june 2015 to november 2019, 87 patients with 92 aneurysms were treated with web-21 (38/92, 41.3%) and web-17 (54/92, 58.7%).Of the patients treated with the web-17, three developed the following complications: patient 1: during the withdrawal of the web-17, the patient's aneurysm ruptured and was rapidly treated with bac (balloon assisted coiling).Patient 2: post treatment with a web-17, the patient was found to have an aneurysm remnant.Patient 3: post treatment with a web-17, the patient was found to have an aneurysm remnant.This is report 3 of 5.(ref.Mfr.Reports #: 2032493-2021-00455, 2032493-2021-00456, 2032493-2021-00459, and 2032493-2021-00460).

Manufacturer Narrative

The lot number is unknown; therefore, a device history record review could not be performed.The devices remain implanted in the patients and not available for return to the manufacturer for analysis, and procedure images were not provided; therefore, the alleged product issue could not be confirmed.The instructions for use (ifu) identifies aneurysm perforation or rupture as potential complications associated with use of the device.

• Brand Name: WEB 17
• 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: 12844918
• MDR Text Key: 283086572
• Report Number: 2032493-2021-00458
• 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,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2021
• 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: 10/21/2021
• 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