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

Model Number	W5-4-2-MVI-3
Medical Device Problem Codes	Off-Label Use (1494); Device Dislodged or Dislocated (2923); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that upon successful treatment of patient¿s rmca bifurcation aneurysm with web device, the doctor and the proctor discussed potential web treatment of the rt.Pcom, which was noted to be off label.There was also the possibility of the web to protrude into the rica.Initial placement was not ideal.Upon second deployment, the web was positioned more favorably, but still protruding some into the rica and still sitting in a different axis than the aneurysm.After obtaining additional imaging, it appeared there was enough web in the aneurysm for it to be stable to detach.A web controller detached the web successfully under fluro.Immediately upon detachment, the web shifted out of the aneurysm and into the rica.Imaging was obtained to ensure the web was not occluding flow through the rica.The physician performed multiple attempts using various devices to remove the web including using an aspiration catheter attached to an aspiration pump and stentriever devices.The web traveled downstream and eventually settled at the previously placed web that was in the rmca bifurcation (m1-m2) aneurysm.The web was successfully snared using a snare device and removed it through the catheter.The previously placed web maintained its position in the rmca bifurcation aneurysm.Additional imaging was done throughout the web removal attempts and confirmed vessels remained open the entire case.The case was completed with the pcom aneurysm being left untreated.The status of any future treatment plans for the pcom aneurysm are unknown despite multiple attempts made to obtain further details.
Additional Manufacturer Narrative
A search for non-conformance's 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 and therefore not available for return and investigation by the manufacturer.However, a video was provided.The investigation is ongoing.Upon completion of the investigation, a supplemental mdr will be submitted.
Additional Manufacturer Narrative
Additional information was received, and it is stated in section b5.A single 19-second video of a subtracted ap roadmap, with contrast, of the right ica was provided for review.A web is seen in a small right mca bifurcation aneurysm.Another web device is located at the mca bifurcation; a snare/microcatheter combination is positioned at the base of this web.A distal access catheter (dac) is advanced from the proximal m1 to the snare and the web/snare are pulled back into the dac.The pcom aneurysm described in the event is superimposed on the supraclinoid ica and is not seen.This video does not explain why the pcom web embolized distally after detachment.Without the return and physical evaluation of the device, the investigation cannot definitively determine if a condition existed that would have caused or contributed to the reported event.
Event or Problem Description
Additional information was received stating that rt pcom aneurysm was being left untreated it is believed at this time there is no plan for retreatment; however, do not know if the physician will eventually retreat or not.Patient did well post procedure and the following day with no adverse effects from case complication.

• Brand Name: WEB SL
• Common Device Name: INTRASALCCULAR 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: 20307015
• Report Number: 2032493-2024-00715
• Device Sequence Number: 15385080
• Product Code: OPR
• UDI-Device Identifier: 00842429110812
• UDI-Public: (01)00842429110812(11)240320(17)270228(10)0000543069
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2024

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 Model Number: W5-4-2-MVI-3
• Device Lot Number: 0000543069
• Was Device Available for Evaluation?: No
• 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: 09/06/2024
• Supplement Date Received by Manufacturer: 09/25/2024
• Initial Report FDA Received Date: 09/25/2024
• Supplement Report FDA Received Date: 10/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/20/2024
• 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: 58 YR
• Patient Sex: Female