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

Model Number W5-3-2-MVI

Device Problems Retraction Problem (1536); Premature Separation (4045)

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

Event Date 04/20/2023

Event Type  malfunction  

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 was implanted in the patient and not returned to the manufacturer for evaluation.Procedural images were provided.The investigation is currently ongoing.Upon completion of the investigation, a supplemental mdr will be submitted.

Event Description

It was reported during the repositioning of the web device, the physician encountered resistance when attempting to retract the web back into the catheter.As the device could not be retracted, the physician decided to implant the web in an non-ideal position.Final images indicated that the final result was ok.The patient outcome is good.Information was requested to clarify how the web was positioned into the non-ideal position and if any intervention was required; however, a response has not been received.

Manufacturer Narrative

Additional information was received, and it is documented in section b5.H6: the medical device problem code was changed for correction from 1536 reaction problem to 4045 premature separation.

Event Description

Additional information was received that stated no surgical intervention was performed.Without being able to retrieve the web into the via, they did the best to navigate the web with limited possibilities to receive the best possible position under these circumstances.

Manufacturer Narrative

Imaging review: two radiographic images are supplied.They are both of poor quality (taken of the monitor screen with a cell phone), highly coned down, and not labeled as to date, time or vessel imaged.Image 1: ap subtracted dsa with contrast.I think it is the basilar artery, but in reality, could be a bifurcation aneurysm anywhere in the brain.There is a small web in the aneurysm.It protrudes in the parent artery and compromises it mildly and the outlet branch on the right of the image severely.Coils are seen remote from the web and are either in the aneurysm treated with web with clot separating the web from the coils, or could be in another, unrelated aneurysm.Image 2: plain single shot unsubtracted radiograph, no contrast.The image shows the web and coils described in image 1.The cause for the web not being able to be retrieved into the via catheter is not seen on these images.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.Lot statement 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.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.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.Users and/or patients should report any serious incidents to the manufacturer and the competent authority of the member state or local health authority in which the user and/or patient is established.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 physician has the discretion to modify the 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.

Event Description

See h.10.

• 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: 16892141
• MDR Text Key: 314818869
• Report Number: 2032493-2023-00715
• Device Sequence Number: 1
• Product Code: OPR
• UDI-Device Identifier: 00842429102046
• UDI-Public: (01)00842429102046(11)220406(17)270331(10)0000174618
• 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: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: W5-3-2-MVI
• Device Lot Number: 0000174618
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2022
• 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