MAUDE Adverse Event Report: MICROVENTION, INC WEB SL 27 SINGLE LAYER; INTRASACCULAR FLOW DISRUPTION DEVICE

Model Number W2-8-3-MVI-3

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Ischemia (1942); Myocardial Infarction (1969); Paresis (1998); Speech Disorder (4415)

Event Date 05/06/2023

Event Type  Injury  

Event Description

As reported through the clinical study web pas (009-001 ae6), subject is a 77-year-old male who consented to the web pas clinical trial on 23mar2023.Subject presented to emergency department on (b)(6) 2023 with right hemiparesis and aphasia; unable to ambulate or speak with right sided weakness.Upon arrival via medflight, symptoms had resolved.Cta shows that left aca stent appears open.Mri done on 07may2023 shows multiple small areas of acute ischemic injury which appear to predominantly confine to the territory of the left anterior cerebral artery suggesting multifocal small infarcts.As of (b)(6) 2023 the subject remained monitored in the hospital, with medications continuing.

Manufacturer Narrative

Please note the patient had an additional stent placed on (b)(6) 2023 post-embolization due to complication from thrombus, and that issue was reported under mdr 2032493-2023-00659.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.Procedural or medical imaging related to this reported issue was not provided.Without the return and physical evaluation of the device, the investigation is unable to determine if a condition existed that would have caused or contributed to the reported event.The event as described could not be confirmed.If imaging is received at a later date, an investigation will be performed and a supplemental mdr will be submitted.H3 other text : device remains implanted.

Manufacturer Narrative

Items returned: - n/a.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: two complaints from the last 2 years are recorded in the complaint handling system with this batch number at the time of this investigation.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: 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 resterilize and/or reuse the device.Reuse and/or resterilization can increase risk of infection, cause a pyrogenic response or other life threatening complications.Reuse and/or resterilization 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 31.The detachment control device is pre-loaded with batteries and will activate when the delivery device is properly connected.32.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.33.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.34.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.35.Verify the embolization device position before pressing the detachment button.36.Push the detachment button.During firing, the light should be solid green and the beep should be continuous.37.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.38.Verify the position of the embolization device angiographically through the guide catheter.39.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.The physical device was not available for evaluation to determine if a condition existed that would have caused or contributed to event.Supplemental imaging was also unavailable for review; without imaging, the investigation cannot verify the event occurred as described, nor could the investigation definitively determine the cause of the reported event.This information may be updated if additional information is provided at a later date.

Event Description

No additional information was received.Please see h6 and h10.

Event Description

Additional information was received noting the following: relationship to study device: possible.Relationship to index endovascular procedure: probable.Relationship to use of ancillary device: possible.Relationship to study disease: possible.Relationship to concomitant disease: possible.Ae outcome: recovered/resolved.Recovered/resolved: date of resolution: (b)(6) 2023.

Manufacturer Narrative

The new information does not have any impact on the data submitted on earlier reports.

• Brand Name: WEB SL 27 SINGLE LAYER
• Type of Device: INTRASACCULAR FLOW DISRUPTION DEVICE
• Manufacturer (Section D): MICROVENTION, INC; 35 enterprise; aliso viejo CA 92656
• Manufacturer (Section G): MICROVENTION, INC; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 16955923
• MDR Text Key: 315498989
• Report Number: 2032493-2023-00731
• Device Sequence Number: 1
• Product Code: OPR
• UDI-Device Identifier: 00842429107140
• UDI-Public: (01)00842429107140(11)220331(17)270228(10)0000172918
• 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: 07/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: W2-8-3-MVI-3
• Device Catalogue Number: W2-8-3
• Device Lot Number: 0000172918
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2022
• 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: 77 YR
• Patient Sex: Male