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

Model Number FG29040-001

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

Patient Problem Aneurysm (1708)

Event Date 02/02/2021

Event Type  Injury  

Manufacturer Narrative

A search for non-conformances associated with this part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The device was implanted in the patient and not returned to the manufacturer for evaluation.Procedural images were not provided for review; therefore, the alleged product issue cannot be confirmed.

Event Description

It was reported that, on (b)(6) 2020, the patient received embolization treatment using a web sls for an aneurysm located in the left anterior cerebral artery.The aneurysm diagnosis was ruptured left anterior cerebral artery aneurysm with an h&h score i (date of rupture (b)(6) 2020).The angiographic result at the end of the procedure is a residual neck (raymond ii).Patient discharged (b)(6) 2020 with an mrs score 1, nihss score not performed.On (b)(6) 2021, almost seven months post procedure, the patient had a complication of apparition of new aneurysm near the neck (2mm diameter).According to the description provided by the site, the event is serious as it led to the patient hospitalization.The action taken in its regards is embolization with a fdv and the outcome is resolved without sequelae (b)(6) 2021.The relationship of the event is related to the study disease.Antiplatelet therapy was provided to the patient.The following medications were administrated: anticoagulant agent (heparin), asa, brillique, and sintrom.

• Brand Name: WEB SLS
• 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: 12130464
• MDR Text Key: 260331548
• Report Number: 2032493-2021-00273
• Device Sequence Number: 1
• Product Code: OPR
• UDI-Device Identifier: 00854111006174
• UDI-Public: (01)00854111006174(11)190204(17)220307(10)19020405
• 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,s
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/11/2021

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: 03/07/2022
• Device Model Number: FG29040-001
• Device Lot Number: 19020405
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/11/2021
• Initial Date FDA Received: 07/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2019
• 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): Hospitalization; Required Intervention
• Patient Age: 73 YR