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

Model Number	FGA15080-040
Medical Device Problem Codes	Unintended Movement (3026); Difficult or Delayed Separation (4044)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Rupture (2208)
Date of Event	07/20/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the web device did not fully detach on the first detachment.The via catheter was advanced slowly, and web detached.The case was reported to be difficult because of the anatomy and angle of the was aneurysm in with the via 27 and caused the web device to rotate.As a result, the aneurysm had a small rupture/bleed after, which was treated with an inflated a competitor balloon device for a few minutes, and the bleeding was then stopped.The patient was monitored overnight and did not re-rupture.The patient woke up okay and intact, and reported to be speaking and responding conversationally.The patient was held at the hospital for a few extra days for observation before discharge.
Additional 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 remains implanted in the patient and not available for return to the manufacturer for analysis; therefore, a product analysis could not be conducted, and the reported issue cannot be confirmed.

• 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: 15188175
• Report Number: 2032493-2022-00351
• Device Sequence Number: 6612481
• Product Code: OPR
• UDI-Device Identifier: 00856956005817
• UDI-Public: (01)00856956005817(11)190729(17)240822(10)19072920
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• Report Date (Section B): 07/20/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/22/2024
• Device Model Number: FGA15080-040
• Device Catalogue Number: FGA15080-040
• Device Lot Number: 19072920
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2022
• Initial Report FDA Received Date: 08/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female