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

Model Number MV-WB090627

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

Patient Problem Aneurysm (1708)

Event Date 11/19/2021

Event Type  Injury  

Event Description

It was reported that there was regrowth of aneurysm 9 months post the web device implantation.Reportedly, upon 30 days follow-up and 180 days follow-up, no regrowth was noted and no additional treatment needed.However, upon nearly 9 months follow-up on (b)(6) 2021, aneurysm regrowth was noted and a stent-assisted coil embolization was performed.Immediately after the procedure, a residual aneurysm was noted.This case was a post market surveillance (pms) case and was also recorded as a residual aneurysm in pms.Current patient condition described as, "the patient was not serious condition, but not yet recovered." no additional treatment is planned at this time.Future follow-up angiography results will determine whether additional treatment is needed or not.

Manufacturer Narrative

A search for non-conformances associated with the reported part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The device remains implanted in the patient; therefore, the alleged product issue cannot be confirmed.

• 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: 14136862
• MDR Text Key: 289452648
• Report Number: 2032493-2022-00145
• Device Sequence Number: 1
• Product Code: OPR
• UDI-Device Identifier: 04987892122477
• UDI-Public: (01)04987892122477(11)200910(17)230831(10)20091011R
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P170032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/25/2022

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 Expiration Date: 08/31/2023
• Device Model Number: MV-WB090627
• Device Lot Number: 20091011R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/25/2022
• Initial Date FDA Received: 04/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2020
• 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