MAUDE Adverse Event Report: MICROVENTION, INC. WEB SL; INTRASACCULAR DEVICES

Model Number W2-8-5-MVI-3

Device Problems Migration (4003); Separation Problem (4043)

Patient Problems Aneurysm (1708); Convulsion/Seizure (4406)

Event Date 06/13/2023

Event Type  Injury  

Manufacturer Narrative

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.The device remains implanted in the patient and not returned to the manufacturer for evaluation.Medical imaging was not provided; however, procedural notes were received.The investigation is ongoing.Upon completion, of the investigation, a supplemental report will be submitted.H3 other text : device remains implanted.

Event Description

As reported through the web pas clinical study, on (b)(6) 2023 a 58-year-old female patient presented to the emergency room following an episode concerning for possible seizure.A ct scan of the head was obtained and demonstrated an unruptured right mca aneurysm.A web device was deployed in the aneurysm with placement in both mca branches patent with excellent coverage of the aneurysm neck.Two detachers were used; however, neither controller successfully detached the web device.Therefore, the microcatheter was then advanced in an attempt to manually detach the device, when doing this the entire device pulled down into the mca bifurcation.The web now impinged on the lower branch.The decision was made to proceed with stenting of the branch.The patient was given a bolus dose of cangrelor followed by a maintenance dose.A microcatheter was then used over a microwire to select the targeted branch.The microwire was able to advance but it was a little difficult to pass the microcatheter.Once this was successful, a wire was placed out of the other branch.A microcatheter was used with a microwire to keep a wire in the other branch.Then the microwire was exchanged for a floppy transcend 300 wire and the microcatheter was removed.At this point the stent was inserted into the microcatheter and deployed in the mca branch.This resulted in significant improvement in the impingement of the web on the branch.The patient was then extubated and taken to the pacu in stable condition.

Manufacturer Narrative

Additional information: procedure note medical review: a detailed medical review of the operative report for complaint (b)(4) has been performed.Data review indicates that the patient was treated for an unruptured right mca aneurysm ((b)(6) 2023).Procedure included embolization of the right mca aneurysm using a web intraocular device.Data review indicates that a web 8 x 5 was initially chosen and deployed within the aneurysm and was determined to be too large.This device was recaptured and a web 8 x 4 was deployed within the aneurysm.Initial placement was found to be excellent.The detacher was then activated, however the web device was found to not be detach.An additional detacher was brought into the field, and again the device would not detach.The microcatheter was advanced in an attempt to manually detach the device which resulted in pulling the device down into the mca bifurcation.Physician made an intraoperative decision to proceed with stenting.Procedure note medical review conclusion for complaint (b)(4).A detailed medical review of the operative report for complaint (b)(4) has been completed.Data review indicates that the initial web device deployed (8 x 5) was determined to be too large and an (8 x 4) web was then deployed.The web 8 x 4 upon activation of the detacher did not detach with the physician trying again with a different detacher which again resulted in non-detachment of the web.Non-detachment of the 8 x 4 web device was confirmed by the physician with confirmation via assessment of the series 16 ap images which were obtained indicating that the device was pulled down into the bifurcation of the mca after attempted manual detachment.No patient injury or harm was reported as a result of the non-detachment of the 8 x 4 web device.Procedure was completed successfully with the physician utilizing a stent.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: 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.Warnings: · advance and retract the web embolization device slowly.Do not advance the delivery device with excessive force.Determine the cause of any unusual resistance.Remove the web embolization device if excessive friction is noted and check for damage.· 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.· the web embolization device cannot be detached with any other power source other than a web detachment control device.Ensure that at least two web detachment control devices are available before initiating an embolization 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.Investigation conclusion: a detailed medical review of the operative report for complaint (b)(4) has been completed.Data review indicates that the initial web device deployed (8 x 5) was determined to be too large and an (8 x 4) web was then deployed.The web 8 x 4 upon activation of the detacher did not detach with the physician trying again with a different detacher which again resulted in non-detachment of the web.Non-detachment of the 8 x 4 web device was confirmed by the physician with confirmation via assessment of the series 16 ap images which were obtained indicating that the device was pulled down into the bifurcation of the mca after attempted manual detachment.No patient injury or harm was reported as a result of the non-detachment of the 8 x 4 web device.Procedure was completed successfully with the physician utilizing a stent.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.Without imaging, the investigation cannot verify the reported event as described.

Event Description

See h10.

• Brand Name: WEB SL
• Type of Device: INTRASACCULAR DEVICES
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise drive; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 17368473
• MDR Text Key: 319476246
• Report Number: 2032493-2023-00856
• Device Sequence Number: 1
• Product Code: OPR
• UDI-Device Identifier: 00842429107157
• UDI-Public: (01)00842429107157(11)221108(17)271031(10)0000281935
• 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: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: W2-8-5-MVI-3
• Device Catalogue Number: W2-8-4
• Device Lot Number: 0000281935
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/13/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/08/2022
• 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
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Weight: 72 KG