MAUDE Adverse Event Report: MICROVENTION, INC. WEB; INTRASACCULAR DEVICES

Model Number	W5-6-4-MVI-3
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A search for non-conformances associated with the reported 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; therefore, the alleged product issue cannot be confirmed.If the device or additional information is received, microvention, inc., will submit a supplemental mdr report.The device remains within the patient.
Event or Problem Description
It was reported that during treatment of an aneurysm, the web did not detach from the delivery pusher.Additional detachment controllers were used unsuccessfully.The devices were reported to pass the prior to use testing.The web was manipulated extensively and was reported to move, tilt within the aneurysm.The web detached within the aneurysm unexpectedly however, not in its original position.The patient was reported to be recovering well.No secondary intervention was taken.

• Brand Name: WEB
• Common Device Name: INTRASACCULAR DEVICES
• 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: 15890462
• Report Number: 2032493-2022-00537
• Device Sequence Number: 6699231
• Product Code: OPR
• UDI-Device Identifier: 00842429110898
• UDI-Public: (01)00842429110898(11)220711(17)250630(10)0000224734
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P170032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2025
• Device Model Number: W5-6-4-MVI-3
• Device Catalogue Number: W5-6-4
• Device Lot Number: 0000224734
• Was Device Available for Evaluation?: No
• 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: 11/15/2022
• Initial Report FDA Received Date: 11/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown