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

Model Number MV-WB080427

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

Patient Problems Perforation (2001); Ruptured Aneurysm (4436)

Event Date 10/12/2022

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 not returned to the manufacturer for analysis as it remains within the patient; therefore, the alleged product issue cannot be verified.The device was implanted in the patient and not returned to the manufacturer for evaluation.Procedural or medical imaging was not provided.The instructions for use (ifu) identifies aneurysm/vessel perforation/rupture as a potential complication associated with use of the device.

Event Description

It was reported that during treatment of an aneurysm in the middle cerebral artery, the web device was advanced in the aneurysm excessively and penetrated the vessel wall of the aneurysm resulting in bleeding.The web device was immediately deployed in the bleeding aneurysm to attempt hemostasis.Angiography revealed that the bleeding had subsided.After confirming that there were no issues, the embolization device was detached and placed in the aneurysm.A balloon catheter was navigated up to the aneurysm, where it was inflated for five minutes to ensure hemostasis again.The final angiography confirmed that there was no bleeding and the procedure was completed successfully.The patient was awakened from anesthesia and returned to the ward with no symptoms.Additional information indicated that the vessel wall of the aneurysm might have been thin due to the complicating avm and could have been perforated upon contact with a foreign body.

• 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 drive; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 15651446
• MDR Text Key: 302194973
• Report Number: 2032493-2022-00414
• Device Sequence Number: 1
• Product Code: OPR
• UDI-Device Identifier: 04987892122415
• UDI-Public: (01)04987892122415(11)200911(17)250831(10)2009111MR
• 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: 10/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: MV-WB080427
• Device Lot Number: 2009111MR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2020
• 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; Required Intervention