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

Model Number W2-8-4-CN

Device Problem Difficult or Delayed Separation (4044)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/12/2023

Event Type  malfunction  

Manufacturer Narrative

The web device remains implanted in the patient and is not available to return for this investigation; however, the 2 controllers used during the procedure were returned to the manufacturer for analysis and the investigation is currently underway.Upon completion of the investigation, a supplemental report will be submitted.Web investigation: visual analysis: a visual inspection of the device captured in this file could not be performed as a physical device was not returned for evaluation, nor were any images of the device provided in place of a device return.Procedure and medical imaging was not provided for this investigation.Investigation findings: 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.Without imaging, the investigation cannot verify the event occurred as described, nor could the investigation definitively determine the cause of the reported event.Based on a review of the device¿s risk documentation, the reported event did not indicate there were any potential or new manufacturing, design, quality, or other systemic issues, or non-conformances.The complaint code is monitored through the trending process; corrective action is determined, as needed, through this process.Investigations of historic complaint files with similar complaint category coding are recorded in the complaint handling system; without the ability to perform and analysis of the device, this investigation cannot identify with certainty any potential root causes.Batch review: 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.Complaint system review: there are no similar complaints based on the complaint category regarding this batch number from the last two years recorded in the complaint system at the time of this investigation.Ifu review (additional information can be found in the ifu): potential complications potential complications include but are not limited to the following: hematoma at the site of entry, aneurysm rupture, emboli, vessel perforation, parent artery occlusion, hemorrhage, ischemia, vasospasm, clot formation, device migration or misplacement, premature or difficult device detachment, non-detachment, incomplete aneurysm filling, revascularization, post-embolization syndrome, and neurological deficits including stroke and death.Warnings and precautions the web aneurysm embolization system is intended for single use only.The detachment control device is intended to be used for one patient.Do not re-sterilize and/or reuse the device.Reuse and/or re-sterilization can increase risk of infection, cause a pyrogenic response or other life-threatening complications.Reuse and/or re-sterilization can degrade product performance, leading to device malfunction.Dispose of all devices in accordance with applicable hospital, administrative and/or local government policy.Advance and retract the device slowly.Do not advance the delivery device with excessive force.Determine the cause of any unusual resistance.Remove the device if excessive friction is noted and check for damage.Do not rotate the delivery device during or after delivery of the embolization device.Rotating the device may result in damage or premature detachment.The embolization device cannot be detached with any other power source other than a microvention inc.Detachment control device.Ensure that at least two detachment control devices are available before initiating an embolization procedure.Procedure detachment of the device 34.The detachment control device is pre-loaded with batteries and will activate when the delivery device is properly connected.35.Verify that the rhv is firmly locked around the delivery device before attaching the detachment control device to ensure that the embolization device does not move during the connection process.36.Ensure that the delivery device gold connectors are clean and free from blood or contrast.If necessary, wipe the connectors with sterile water and dry before connecting.37.Insert the proximal end of the delivery device into the detachment control device.When the delivery device is properly connected, the light will flash green, and an intermittent tone will be heard.38.Verify the embolization device position before pressing the detachment button.39.Push the detachment button.During firing, the light should be solid green, and the beep should be continuous.40.Verify detachment by first loosening the rhv valve, then pulling back slowly on the delivery device and verifying that there is not embolization device movement.If the embolization device does not detach, push the detachment button again.If the device is still not detached, obtain a new detachment control device and attempt detachment up to two additional times.If it does not detach, remove the delivery device.41.Verify the position of the embolization device angiographically through the guide catheter.42.Prior to removing the microcatheter from the treatment site, place an appropriately sized guidewire completely through the microcatheter lumen to ensure that no part of the embolization device remains within the microcatheter.

Event Description

It was reported that during the procedure, multiple attempts were used to detach the web device with the controller; however, was unable to be detached.Replaced the controller with a new one, and the same issue was encountered; the web was unable to be detached with the second controller.A third controller was used and able to complete the procedure.There was no reported patient injury and the patient was reported to be normal.

Event Description

Please see section h10 for investigation of the 2 detachment controllers received used during the procedure of the reported web device.

Manufacturer Narrative

Investigation findings: the web device was not received/evaluated for this investigation; the investigation results were provided on the initial mdr report.Items returned: 2 controllers.Controller(s) investigation: the returned controllers were evaluated and found to be functioning as normal.Controller 1 investigation: the wdc-2 board voltage and firing duration was measured using an oscilloscope.When the wdc-2 was inserted into the test fixture, a green light appeared with normal audio output.Voltage: 11.6v (specification: 11.2 - 11.8v per cf11434), duration: 751.2ms (specification: 660 - 820ms per cf11434), the wdc-2 board voltage and duration was found to be within specification.Controller 2 investigation: the wdc-2 board voltage and firing duration was measured using an oscilloscope.When the wdc-2 was inserted into the test fixture, a green light appeared with normal audio output.Voltage: 11.5v (specification: 11.2 - 11.8v per cf11434), duration: 740.3ms (specification: 660 - 820ms per cf11434), the wdc-2 board voltage and duration was found to be within specification.Investigation conclusion: two controllers were received in place of the web device and were found to function normally.The web device was not received for evaluation; therefore, this complaint is unable to be verified.Without the return and physical evaluation of the web, the investigation cannot determine if a condition exists that would have caused on contributed to the reported event.

• Brand Name: WEB SL
• Type of Device: 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: 18156611
• MDR Text Key: 329102148
• Report Number: 2032493-2023-01054
• Device Sequence Number: 1
• Product Code: OPR
• UDI-Device Identifier: 00842429113868
• UDI-Public: (01)00842429113868(11)211029(17)250930(10)0000109573
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P170032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/16/2024

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
• Device Operator: Health Professional
• Device Model Number: W2-8-4-CN
• Device Lot Number: 0000109573
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/29/2023
• Initial Date FDA Received: 11/16/2023
• Supplement Dates Manufacturer Received: 01/11/2024
• Supplement Dates FDA Received: 01/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 86 YR
• Patient Sex: Female
• Patient Weight: 55 KG