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

Model Number	W5-5-S-MVI-3
Medical Device Problem Codes	Activation Problem (4042); Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2021
Type of Reportable Event	Serious Injury
Additional 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 remains implanted in the patient; therefore, the alleged product issue cannot be confirmed.The instructions for use (ifu) identifies migration or misplacement and premature detachment as potential complications associated with use of the device.
Event or Problem Description
It was reported that the web device was used for treatment of a right middle cerebral artery (mca) aneurysm measuring w-4.01 and h-4.24 neck-2.65.Pru was a 6.The device was deployed but it would not detach using 2 detachment controllers.When the physician pulled back the microcatheter before 2nd try on detacher, the wire pushed forward.The physician needed to reposition the device but it pulled out of the aneurysm and sitting in the bifurcation.Part of the web was re-sheathed but detached and was not visible.Attempt to recapture the device was unsuccessful and it pushed more distal in the m1.The decision was made to use a stent in the inferior branch and trap the device.A second web device was successfully deployed and detached and flow was steady throughout the procedure.Patient woke up normal.
Additional 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 remains implanted in the patient; therefore, the alleged product issue cannot be confirmed.The instructions for use (ifu) identifies migration or misplacement and premature detachment as potential complications associated with use of the device.
Event or Problem Description
It was reported that the web device was used for treatment of a right middle cerebral artery (mca) aneurysm measuring w-4.01 and h-4.24 neck-2.65.Pru was a 6.The device was deployed but it would not detach using 2 detachment controllers.When the physician pulled back the microcatheter before 2nd try on detacher, the wire pushed forward.The physician needed to reposition the device but it pulled out of the aneurysm and sitting in the bifurcation.Part of the web was re-sheathed but detached and was not visible.Attempt to recapture the device was unsuccessful and it pushed more distal in the m1.The decision was made to use a stent in the inferior branch and trap the device.A second web device was successfully deployed and detached and flow was steady throughout the procedure.Patient woke up normal.

• 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: 13359488
• Report Number: 2032493-2022-00031
• Device Sequence Number: 16556042
• Product Code: OPR
• UDI-Device Identifier: 00842429110874
• UDI-Public: (01)00842429110874(11)210524(17)240430(10)21052413G
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/29/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2024
• Device Model Number: W5-5-S-MVI-3
• Device Catalogue Number: W5-5-S
• Device Lot Number: 21052413G
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2021
• Initial Report FDA Received Date: 01/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female