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

Model Number	W5-4.5-2-MVI-3
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	01/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that when detaching the web device during a ruptured middle cerebral artery (mca) aneurysm case, a delayed detachment from the wire caused the device to move back and it covered the inferior mca branch.The physician utilized integrilin bolus and brilinta, waited 5 minutes and it appeared the occlusion was at m2 segment.The physician implanted a lvis jr.Stent to support the web.The m2 segment remines occluded.The patient was discharged 3 days post procedure and is neurologically intact.
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; however, procedure images were provided and are being reviewed.Upon completion of investigation, a supplemental report will be submitted.The instructions for use (ifu) identifies device migration or misplacement and parent artery occlusion as potential complications associated with use of the device.
Additional Manufacturer Narrative
Additional information received.The physician indicated that the patient did great.Woke up asymptomatic (other than headache) and discharged asymptomatic as well.Just keeping on 9 months of dapt.
Additional Manufacturer Narrative
Additional information: h6, h10.The device associated with this event was used during the same procedure referenced in mfr.Report# 2032493-2022-00637.Summary of 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.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.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: vessel puncture site hematoma, aneurysm perforation or rupture, hemorrhage, edema, thromboemboli, transient ischemic attack, ischemic stroke, neurologic deficits, parent artery occlusion, ischemia, vessel dissection or perforation, vascular thrombosis, vasospasm, device migration or misplacement, premature detachment, headache, post-embolization syndrome, infection and death.The web embolization device requires the use of fluoroscopy.Potential complications related to angiographic and fluoroscopic radiation doses include, but are not limited to, alopecia, burns ranging in severity from skin reddening to ulcers, cataracts, and delayed neoplasia.The probability of occurrence of complications may increase as procedure time and number of procedures increase.Other procedural complications including but not limited to anesthetic and contrast media risks, hypotension, hypertension and access site complications.Warnings do not rotate the delivery device during or after delivery of the web embolization device.Rotating the web embolization device may result in damage or premature detachment.Procedure - instructions for use detachment of the web embolization 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 web 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 web 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 web embolization device movement.If the web embolization device does not detach, push the detachment button again.If the web embolization 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 web 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 web embolization device remains within the microcatheter.The physician has the discretion to modify the web embolization device deployment technique based on the complexity and variation in embolization procedures.Any modifications must be consistent with the previously described procedures, warnings, precautions and patient safety information in these instructions for use.Investigation conclusion: the physical device was not returned for evaluation; seven images from the procedure were provided for review as part of this investigation.In first image unsubtracted dsa of right mca, ap, with contrast.There is a web in a small mca bifurcation aneurysm; it is not detached from the pusher, and the via catheter is in the distal m1, proximal to and separate from the web detachment marker.Second image is a subtracted dsa of right mca, ap, with contrast.The web is detached in the aneurysm.The via catheter is in the superior portion of the m1, above another microcatheter/microguidewire positioned from the m1, through the inferior division of the m1 and its vertical m1 continuation.M1 and both m2 divisions are open.The proximal web detachment marker is situated inside the aneurysm at the junction of the m1 and the take off of the superior mca division.Third image is an unsubtracted dsa of right mca, ap, with contrast.The via catheter has been removed and the web is partially in the aneurysm with its proximal part in the distal m1, crossing the origin of the lower mca division, which still has flow.Fourth image is the same as image 3, but close up.Fifth image is a lateral subtracted whole head right ica dsa with contrast.Normal angiogram.The web cannot be seen, because of projection overlap.Sixth image is a subtracted dsa of right mca, ap, with contrast.The web is detached in the aneurysm.The via is in the superior portion of the m1, above another microcatheter/microguidewire positioned from the m1, through the inferior division of the m1 and its vertical m1 continuation.M1 and is the superior mca division are open.There is almost no flow in the lower division.The proximal web protrudes into the mca bifurcation and almost occludes the lower division origin.Seventh image is an unsubtracted dsa of right mca, ap, with contrast.An lvis stent has been positioned from the inferior division m2 vertical segment to the mid m1.The lvis is fully open until just proximal to the mca bifurcation, where it starts to taper down.The portion of lvis that is in the inferior division is at best 1/3 open.The inferior division is open, with blood flow (ref.Mfr.Report# 2032493-2022-00637).The mechanism of shifting of the web that caused the complication seems to have occurred at the time of the maneuvers required to deal with the sticky tether.Without the return and physical evaluation of the device, the investigation cannot determine if a condition exists that would have caused or contributed to the reported event.

• 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: 16286885
• Report Number: 2032493-2023-00548
• Device Sequence Number: 17379108
• Product Code: OPR
• UDI-Device Identifier: 00842429110799
• UDI-Public: (01)00842429110799(11)220517(17)250430(10)0000189728
• 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: 2023
• 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,Followup
• Report Date (Section B): 01/18/2023

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: 04/30/2025
• Device Model Number: W5-4.5-2-MVI-3
• Device Catalogue Number: W5-4.5-2
• Device Lot Number: 0000189728
• 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: 01/18/2023
• Supplement Date Received by Manufacturer: 03/16/2023; 04/11/2023
• Initial Report FDA Received Date: 02/02/2023
• Supplement Report FDA Received Date: 03/29/2023; 04/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/17/2022
• 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: 50 YR
• Patient Sex: Female