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

Model Number W5-6-3-MVI

Device Problems Separation Failure (2547); Device Dislodged or Dislocated (2923)

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

Event Date 03/24/2021

Event Type  Injury  

Manufacturer Narrative

The device was implanted in the patient and not returned to the manufacturer for evaluation.Procedural images were not provided for review; therefore, the alleged product issue cannot be confirmed.A search for non-conformances associated with this part/lot number combination did not reveal any production-related issuesrelevant to the complaint that occurred during manufacturing of the device.The instructions for use identifies migration or misplacement as potential complications associated with use of the device.

Event Description

It was reported that during a treatment of a acom aneurysm, the web was in a good position inside the acom aneurysm.An attempt was made to detach the web with two detachment controllers unsuccessfully.The delivery pusher was pulled and pushed while manipulating the microcatheter.The delivery pusher was rotated to detach the web.The web did not remain in the desired position so a stent was placed.No harm or injury was reported.

• 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: 11904854
• MDR Text Key: 256063802
• Report Number: 2032493-2021-00193
• Device Sequence Number: 1
• Product Code: OPR
• UDI-Device Identifier: 00842429102138
• UDI-Public: (01)00842429102138(11)210113(17)251231(10)21011314A
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P170032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: W5-6-3-MVI
• Device Lot Number: 21011314A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention