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

Model Number W2-11-6

Device Problem Difficult or Delayed Separation (4044)

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

Event Date 11/10/2023

Event Type  malfunction  

Manufacturer Narrative

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.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 were no complaints from the last 2 years 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.Risk analysis statement 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.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.¿ the web embolization device must be delivered only through a compatible microcatheter with a ptfe inner surface coating.Damage to the embolization and delivery device may occur and necessitate removal of both the device and microcatheter from the patient.¿ 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.Procedure introduction and deployment of the device 15.Open the rhv on the microcatheter to accept the introducer sheath.16.Insert the introducer sheath through the rhv.Seat the distal tip of the introducer sheath at the distal end of the microcatheter hub and close the rhv lightly around the introducer to secure the rhv to the introducer.Do not over-tighten the rhv.Only insert the introducer into the microcatheter hub until a slight resistance is felt.Do not over insert.17.Push the device into the lumen of the microcatheter.Use caution to avoid catching the embolization device on the junction between the introducer sheath and hub of the microcatheter.18.Push the device through the microcatheter until the proximal end of the delivery device meets the proximal end of the introducer sheath.19.Loosen the rhv.20.Retract the introducer sheath just out of the rhv.21.Close the rhv around the delivery device.22.Slide the introducer sheath completely off the delivery device using care not to kink or damage the delivery system.23.Carefully advance the device until the distal end of the device reaches the last marker on the microcatheter.24.Reposition the tip of the microcatheter so that it sits just at the neck of the aneurysm.Do not insert the microcatheter completely inside the aneurysm.25.Under fluoroscopic guidance, slowly advance the embolization device out the tip of the microcatheter.Continue to advance the embolization device into the lesion until optimal deployment is achieved.The following may require repositioning or removal of the emboization device and/or repositioning of the microcatheter: a.If the embolization device size is not appropriate, remove and replace with another device.B.If undesirable movement of the embolization device is noted following placement and prior to detachment, remove the device.Movement of the embolization device may indicate that the device could migrate once it is detached.C.If the embolization device (implant) does not fully open: i.Retrieve the implant, reposition the microcatheter further proximally and re-deploy the implant to allow more room for expansion; or ii.Replace the implant with another implant of the same or alternate size.The embolization device should not be retracted and deployed more than twice.After two attempts, remove the embolization device and replace with another device of the same or alternate size.To minimize the potential risk of emboli, do not allow an inappropriately sized or non-optimally positioned device to reside in the aneurysm significantly beyond the activated clotting time (act).Experience has shown that blood/clot can also prevent the web embolization device from full deployment and recapture.To minimize the risks of potential complications, the status of the patient¿s anti-platelet medication regimen should be considered when making a decision to remove the entire system from the aneurysm for replacement by a new device.26.Angiographic assessment should always be performed prior to detachment to ensure that the embolization device is not markedly protruding into the parent vessel.27.The web embolization device should be placed with the proximal surface (center of proximal marker) aligned with the aneurysm neck and the proximal marker extending beyond the neck.28.If redeploying, retract device so that there is no contact with the aneurysm before attempting redeployment.29.Tighten the rhv to prevent movement of the embolization device.30.Verify that the distal portion of the delivery device is not under tension or compression prior to detachment.This could cause the microcatheter tip to move resulting in aneurysm or vessel rupture.

Event Description

It was reported that after the web device was deployed into the aneurysm sac, the physician attempted to detach it.The wdc detachment controller displayed a green light, but the web device did not detach.The microwire was then pulled out to try to release the web device, but it stayed connected.Two wdc detachment controllers were used to try to detach the web device, but they both displayed red lights.By pulling, pushing, and massaging the device, it finally detached and was successfully implanted in the intended aneurysm sac.A controlled angio was performed and the procedure was completed.No patient injury or intervention was reported.The patient is in good condition.

• 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: 18186579
• MDR Text Key: 328974593
• Report Number: 2032493-2023-01068
• Device Sequence Number: 1
• Product Code: OPR
• UDI-Device Identifier: 00842429102480
• UDI-Public: (01)00842429102480(11)221006(17)270930(10)0000266882
• Combination Product (y/n): N
• Reporter Country Code: LO
• PMA/PMN Number: P170032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: W2-11-6
• Device Lot Number: 0000266882
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2022
• 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