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

Model Number	W5-4-2-MVI-3
Medical Device Problem Codes	Difficult or Delayed Activation (2577); Migration (4003)
Health Effect - Clinical Code	Ruptured Aneurysm (4436)
Date of Event	03/03/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device lot number was not provided; therefore, a device history record and non-conformance's could not be performed.The device remains implanted in the patient; therefore, the alleged product issue cannot be confirmed.The instructions for use (ifu) identifies device migration or misplacement, and aneurysm perforation or rupture as potential complications associated with use of the device.
Event or Problem Description
It was reported that during an aneurysm treatment procedure, there was initial detachment difficulty of the web with multiple detachment attempts.Reportedly due to forced microcatheter manipulation during detachment attempts, the web came out of the aneurysm and migrated to the aca/mca junction.A pipeline shield embolization device was used to successfully secure the web in place.After the web was secured and the pipeline fully opened, the original aneurysm was attempted to be coiled when it ruptured on placement of non-microvention coils.A balloon was inflated immediately and the bleed was slowed and then stopped.The patient woke up fine and intact; and was speaking and responding conversationally.An evd was placed later that evening as a precaution.The patient was held at hospital for a few extra days for observation before discharge.
Additional Manufacturer Narrative
Additional information received.The web device was used to treat an acomm aneurysm.Patient is doing fine and will keep on dapt with aspirin and plavix.Patient will be brought back for 3 months follow up angiogram.

• Brand Name: WEB SL
• Common Device Name: 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: 13939249
• Report Number: 2032493-2022-00117
• Device Sequence Number: 6432174
• Product Code: OPR
• UDI-Device Identifier: 00842429110812
• UDI-Public: (01)00842429110812(11)211008(17)240930(10)0000096114
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P170032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2024
• Device Model Number: W5-4-2-MVI-3
• Device Catalogue Number: W5-4-2
• Device Lot Number: 0000096114
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2022
• Supplement Date Received by Manufacturer: 03/29/2022
• Initial Report FDA Received Date: 03/29/2022
• Supplement Report FDA Received Date: 04/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SCEPTER XC BALLOON CATHETER.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female