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

Model Number W5-3.5-2-MVI

Device Problems Device Dislodged or Dislocated (2923); Migration (4003); Difficult or Delayed Separation (4044)

Patient Problems Paresis (1998); Obstruction/Occlusion (2422); Speech Disorder (4415)

Event Date 03/19/2023

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.Procedural or medical imaging were not provided.The difficult or delayed separation product issue could not be confirmed.If the additional information is received at a later date, a supplemental mdr will be submitted.

Event Description

As reported during a procedure to treat a ruptured acom aneurysm with a web device.Multiple unsuccessful attempts were made to detach the web device with multiple detachers.During an attempt to resheath the device the web unexpectedly detached partially inside the aneurysm and then migrating into the proximal left a2.An attempt was made to snare the device unsuccessfully.The aneurysm was occluded using 1 detachable coil with immediate occlusion partly due to rapid intraaneurysmal clot formation.Control run reveals initially, retrograde filling of left aca towards the occlusion site which is less clearly visible at the end of the procedure due to smaller embolic occlusions in the periphery of the left mca territory.Right ica injection shows some cross flow to the left mca.The patient is reported to have aphasia and has right-sided paresis following procedure on (b)(6).

Event Description

See h10.

Manufacturer Narrative

Additional information h6 codes.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: 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: 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 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 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 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 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.Verify the position of the 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 embolization device remains within the microcatheter.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; 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 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: 17410975
• MDR Text Key: 319930498
• Report Number: 2032493-2023-00867
• Device Sequence Number: 1
• Product Code: OPR
• UDI-Device Identifier: 00842429102039
• UDI-Public: (01)00842429102039(11)220920(17)270831(10)0000260647
• 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: Other
• 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: 07/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: W5-3.5-2-MVI
• Device Lot Number: 0000260647
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2022
• 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