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

Model Number	W5-7-5-MVI-3
Medical Device Problem Codes	Unintended Movement (3026); Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an aneurysm treatment procedure, there was detachment difficulty of the web device with multiple detachment attempts.Advancement of the microcatheter to the proximal marker of the web eventually aided in detachment.However, the manipulation of the web delivery wire and microcatheter resulted in the web becoming inverted post detachment.Occlusion of aneurysm was adequate.The patient had good outcome and woke up moving all extremities and talking.
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 web device remains implanted and will not be returned for evaluation.However, two subtracted dsa images of a right ica angiogram were provided, the pusher delivery wire was received, and the investigation is ongoing.Once the investigation is completed, a supplement report will be submitted.
Additional Manufacturer Narrative
Summary device evaluation: the investigation of the returned delivery system found the proximal end kinked; however, it was still able to be inserted into an in-house controller.The funnel diameter of the returned controllers were found to be out of specification, which caused the delivery system to experience friction as described in the complaint.The investigation of the returned delivery system did not find any other damage that would have caused or contributed to the reported complaint.Review of the provided imaging could not verify the web device being "inverted a bit" since the device itself is not well visualized.

• 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: 15230647
• Report Number: 2032493-2022-00318
• Device Sequence Number: 4899484
• Product Code: OPR
• UDI-Device Identifier: 00842429110942
• UDI-Public: (01)00842429110942(11)211122(17)241031(10)0000124910
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,Followup
• Report Date (Section B): 07/29/2022

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: 10/31/2024
• Device Model Number: W5-7-5-MVI-3
• Device Catalogue Number: W5-7-5
• Device Lot Number: 0000124910
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2022
• Supplement Date Received by Manufacturer: 08/25/2022
• Initial Report FDA Received Date: 08/15/2022
• Supplement Report FDA Received Date: 08/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2021
• 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 Sex: Female