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

Model Number W4-5-3-CN

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

Patient Problem Ruptured Aneurysm (4436)

Event Date 12/09/2021

Event Type  Injury  

Manufacturer Narrative

The device lot number is unknown; therefore, a search for non-conformances associated with the actual part/lot number combinations cound not be performed.The investigation of the returned device found the delivery system with multiple kinks and the implant with broken wires.However, there was no specific product failure described in the complaint.The physical evaluation of the device could not identify the conditions or circumstances that led to the damage, but the damage is consistent with the device experiencing forces over specification.Additionally, procedural images were not provided; therefore, the reported event cannot be confirmed.The instructions for use (ifu) identifies aneurysm perforation or rupture as a potential complication associated with use of the device.

Event Description

It was reported that during treatment of an aneurysm located in the bifurcation of right middle cerebral artery, the aneurysm wall ruptured when the web was deployed.The operator switched to filling the aneurysm with coils and the bleeding was controlled.The patient's condition was reported to be "good" after the surgery.The physician remarked that they did not consider it to be a product related issue.

• 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: 13173782
• MDR Text Key: 283314983
• Report Number: 2032493-2022-00009
• Device Sequence Number: 1
• Product Code: OPR
• UDI-Device Identifier: 00842429113721
• UDI-Public: (01)00842429113721(11)210915(17)250831(10)0000079854
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 12/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: W4-5-3-CN
• Device Lot Number: 0000079854
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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): Required Intervention
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 55 KG