MAUDE Adverse Event Report: MICROVENTION INC. WEB 17 SL 6X2; INTRASACCULAR FLOW DISRUPTION DEVICE

Model Number	W5-6-2-MVI
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an aneurysm embolization case, a web device did not detach.Various maneuvers were carried out (pulling the pusher, approaching with the micro, twisting the pusher) but without success.It was removed and another web was implanted successfully.There was no injury or intervention.The patient was reported to be ¿fine.¿.
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 was returned to the manufacturer for analysis.The investigation is currently ongoing.
Event or Problem Description
It was reported that during an aneurysm embolization case, a web device did not detach.Various maneuvers were carried out (pulling the pusher, approaching with the micro, twisting the pusher) but without success.It was removed and another web was implanted successfully.There was no injury or intervention.The patient was reported to be ¿fine.¿.
Additional Manufacturer Narrative
Items returned for evaluation: web implant.Items not returned for evaluation: delivery system (pusher); introducer; dispenser hoop; microcatheter; controller.The visual analysis of the returned item found the web implant to be separated from the pusher.The pusher was not returned for evaluation.The web implant was found to be within visual and dimensional specifications.Further inspection found that the heater coil windings stretched, broken, and stuck onto the implant tether.The implant tether appeared to be melted.The investigation found the web implant to be separated from the pusher.The pusher was not returned for evaluation.Further inspection found the heater coil windings to be stretched, broken, and stuck onto the implant tether.The implant tether was found melted, indicating that the device was activated using a detachment controller during the procedure.The stretched heater coil windings are an indication that the tether could have been caught in between the coil windings and caused the heater coil to stretch likely during the various push, pull, and twisting maneuvers performed with the delivery system as described in the reported event.

• Brand Name: WEB 17 SL 6X2
• 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: 20377987
• Report Number: 2032493-2024-00743
• Device Sequence Number: 3689006
• Product Code: OPR
• UDI-Device Identifier: 00842429117996
• UDI-Public: 00842429117996
• Combination Product (Y/N): N
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2024

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 Model Number: W5-6-2-MVI
• Device Catalogue Number: W5-6-2
• Device Lot Number: 0000364872
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2024
• 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: 09/12/2024
• Supplement Date Received by Manufacturer: 10/11/2024
• Initial Report FDA Received Date: 10/04/2024
• Supplement Report FDA Received Date: 11/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2023
• 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
• Patient Age: 60 YR
• Patient Sex: Female