MAUDE Adverse Event Report: MICROVENTION, INC. WEB SL 21 SINGLE LAYER; INTRASACCULAR FLOW DISRUPTION DEVICE

Model Number	W4-5-3-MVI-3
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2021
Type of Reportable Event	Serious Injury
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 implanted in the patient and was not returned to the manufacturer for evaluation.Additionally, procedural images were not provided; therefore, the reported event cannot be confirmed.The instructions for use (ifu) identifies device misplacement and vessel occlusion as potential complications associated with use of the device.
Event or Problem Description
It was reported that an intrasaccular flow disruption device (web sl) was used for treatment of a basilar apex aneurysm.After successful deployment, the web would not detach and separate from the delivery wire when the detachment controller was activated.The web detached successfully after manipulation of the delivery wire using push/pull technique.Reportedly, a slight proximal reposition of the web device at the aneurysm neck was noted, which resulted in greater than 50% covering of the left posterior cerebral artery (pca).An intraluminal support stent device (lvis jr) was successfully deployed, which provided optimum coverage at the neck by pushing the web device protrusion back into the aneurysm.The left pca was fully patent.The patient was reported to be "stable.".

• Brand Name: WEB SL 21 SINGLE LAYER
• Common Device Name: INTRASACCULAR FLOW DISRUPTION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 11971298
• Report Number: 2032493-2021-00221
• Device Sequence Number: 3388337
• Product Code: OPR
• UDI-Device Identifier: 00842429106990
• UDI-Public: (01)00842429106990(11)201021(17)250930(10)201021127
• 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: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2025
• Device Model Number: W4-5-3-MVI-3
• Device Catalogue Number: W4-5-3
• Device Lot Number: 201021127
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2021
• Initial Report FDA Received Date: 06/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention