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

Model Number W5-7-3-MVI-3

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Fatigue (1849); Speech Disorder (4415)

Event Date 05/05/2023

Event Type  Injury  

Event Description

As reported in web pas clinical trial, a patient with no significant history found to have a 6mm incidental acom aneurysm.A web sl was implanted; however, post procedure, the patient developed aphasia, global lethargy and right arm drift.The patient returned to the or and angiography showed the web sl device was unstable.Reportedly, the physician retrieved the web device and placed another.The patient had no spasm or acute stroke on ct and eeg was in progress.

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 was implanted in the patient and is not available to return to the manufacturer for analysis and procedure images not provided.Therefore, the alleged product issue cannot be confirmed.If additional information is received, a supplemental report will be submitted.The instructions for use (ifu) identifies device migration or misplacement and/or neurologic deficits as potential complications associated with use of the device.

Manufacturer Narrative

Additional information was received indicating that replacement device was a web sl.The patient was discharged to home and put on keppra medication for neurologic deterioration.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: 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 japanese ifu, the following is from the english version): 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.Web embolization device size selection 7.The web implant should be deployed using device diameter over-sizing relative to the diameter of the target lesion.See the "warnings" section for additional information for the safe deployment of the web embolization device.8.Understand the aneurysm shape, width and height by performing 2d-angiographic fluoroscopy in two orthogonal projections.9.Measure the aneurysm necks, diameters, and heights of the aneurysm in each projection.Investigation conclusion: 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 and 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.

• 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: 16989775
• MDR Text Key: 315825532
• Report Number: 2032493-2023-00745
• Device Sequence Number: 1
• Product Code: OPR
• UDI-Device Identifier: 00842429110928
• UDI-Public: (01)00842429110928(11)210218(17)240131(10)210218145
• 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,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: W5-7-3-MVI-3
• Device Catalogue Number: W5-7-3
• Device Lot Number: 210218145
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/18/2021
• 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 Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 52 KG