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

Model Number W5-6-4-MVI-3

Device Problems Device Dislodged or Dislocated (2923); Premature Separation (4045)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/15/2022

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 307769444
• Report Number: 2032493-2022-00537
• Device Sequence Number: 1
• Product Code: OPR
• UDI-Device Identifier: 00842429110898
• UDI-Public: (01)00842429110898(11)220711(17)250630(10)0000224734
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P170032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 11/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2022
• Is the Device Single Use?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other