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

Model Number W5-7-3-MVI-3

Device Problems Dent in Material (2526); Difficult or Delayed Separation (4044)

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

Event Date 02/20/2023

Event Type  Injury  

Event Description

It was reported that the web device was used to treat a patient with a basilar alex aneurysm.Reportedly during deployment, there was delayed detachment and the web detached after multiple attempts with the detachment controller that resulted in indentation on the web.A snare device was used to correct the indentation on the web, which was deployed in intended location.There was no report of harm or injury to the patient, who was fine.Additional information received.The case for treating a basilar alex aneurysm.Physician was trying to detach web from pusher wire resulted in an indentation.Tried to detach it 4x and our detachment device failed 3x.Patient anatomy was extremely straight forward.

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 their review is ongoing.Mvi will submit a supplemental report when image review is complete.

Manufacturer Narrative

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, 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: based on a review of the last 2 years of complaint data, and at the time of this investigation, no systemic issues have been identified for this batch number that would have caused or contributed to the reported event.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: the detachment control device is pre-loaded with batteries and will activate when the delivery device is properly connected.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.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.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.Verify the web embolization device position before pressing the detachment button.Push the detachment button.During firing, the light should be solid green and the beep should be continuous.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.Verify the position of the web embolization device angiographically through the guide catheter.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 device remains implanted in the patient; however, a set of images were provided for review for this investigation.Fist image is a single shot un-subtracted lateral radiograph, no contrast.A detached web is seen in the basilar aneurysm described in the report.The via microcatheter is in the mid-basilar artery.The web is moderately indented at its base.Second image is an ap subtracted basilar dsa with contrast.The web is in the aneurysm, still attached to the pusher.Its base is slightly stretched into the basilar terminus.Third image is a lateral oblique subtracted dsa with contrast.The web is in the aneurysm, still attached to the pusher.Fourth image is an ap subtracted basilar dsa with contrast.The web is detached and well-positioned, with mild (presumably intentional) protrusion into the terminus, with no impairment of the p1 segments.The indent at the base of the web is not seen.Fifth and sixth image are the same as fourth image, but slightly different projection.No images of the snaring maneuver that was done to reposition the web are supplied.Without the return and physical evaluation of the device, 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: 16507411
• MDR Text Key: 310951043
• Report Number: 2032493-2023-00603
• Device Sequence Number: 1
• Product Code: OPR
• UDI-Device Identifier: 00842429110928
• UDI-Public: (01)00842429110928(11)220705(17)250630(10)0000215939
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: W5-7-3-MVI-3
• Device Catalogue Number: W5-7-3
• Device Lot Number: 0000215939
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/05/2022
• 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 Outcome(s): Required Intervention