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

Model Number W5-6-3-MVI

Device Problems Malposition of Device (2616); Difficult or Delayed Separation (4044)

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

Event Date 03/19/2024

Event Type  Injury  

Manufacturer Narrative

Investigation findings: items returned: - n/a visual analysis: a visual inspection of the device captured in this file could not be performed as the physical device remains implanted in the patient and was not returned for evaluation.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.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: 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 re-sterilize and/or reuse the device.Reuse and/or re-sterilization can increase risk of infection, cause a pyrogenic response or other life-threatening complications.Reuse and/or re-sterilization 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.Procedure/medical/image information review: thirteen radiographic images were provided for review.Some are identified as to date or time but were not submitted in chronological order.An attempted was made to reorder them.The review of the images is as follows: customer image 2: 3d left ica dsa, working projection.There is an acom aneurysm.Measurements: neck 3.9 mm, width 4.49 mm, depth 5.28 mm.Customer image 10: 3d left ica dsa, orthogonal working projection.There is an acom aneurysm.Measurements: neck 3.93 mm, width 4.95 mm, depth 4.19 mm.Customer image 5: ap & lateral left ica dsa, subtracted, with contrast.A microcatheter is in the left a1.Customer image 8: ap & lateral left ica dsa, subtracted, with contrast.A microcatheter is positioned deep into the aneurysm.Customer image 1: ap & lateral left ica dsa, subtracted, with contrast.A guide catheter is in the proximal petrous ica.A microcatheter is in the left a1 and a non-detached web is in a small acom aneurysm.Customer image 4: ap and lateral oblique working single shot image, non-subtracted, no contrast.A microcatheter is in the left a1 and a non-detached web is seen in the aneurysm.Customer image 6: ap & lateral left ica dsa, subtracted, with contrast.A microcatheter is in the left a1 and a non-detached web is in the aneurysm.Customer image 13: ap & lateral left ica dsa, subtracted, with contrast.The web has been detached.It is protruding moderately to markedly in the left a2 and minimally into the right a2.The microcatheter is seen proximally.Customer image 7: ap & lateral left ica dsa, subtracted, with contrast.The web has been detached and the microcatheter has been removed.It is protruding moderately to markedly in the left a2 and minimally into the right a2.Customer image 9: ap and lateral oblique working single shot image, non-subtracted, no contrast.A web is seen in the aneurysm.There is good lateral compression.Customer image 12: ap and lateral oblique working dsa, non-subtracted, with contrast.A web is seen in the aneurysm.A microcatheter has been navigated over a guidewire into the left a2.Customer image 11: ap and lateral oblique working dsa, non-subtracted, with contrast.A web is seen in the aneurysm and an atlas stent has been deployed from the left a2 to the left a1.There is minor encroachment on the left a2 and a1 origins.Customer image 3: ap and lateral oblique working single shot image, non-subtracted, no contrast.A web is seen in the aneurysm and an atlas stent has been deployed from the left a2 to the left a1.Investigation conclusion: thirteen radiographic images were provided for review.The images show the web protruding markedly in the left a2 and minimally into the right a2 post-detachment as described in the reported event; however, these images do not explain why there were problems with the web detachment.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.Potential complications as referenced on the ifu, 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.

Event Description

It was reported that after implantation in desired position, the web device did not detach in several attempts with different wdc controllers.We needed to manipulate mechanically, and this led to malposition of the device.A stent was then implanted for correcting the position of the web.The patient was reported to have no neurological deficit.

• 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: 19094118
• MDR Text Key: 339988291
• Report Number: 2032493-2024-00294
• Device Sequence Number: 1
• Product Code: OPR
• UDI-Device Identifier: 00842429102138
• UDI-Public: (01)00842429102138(11)230420(17)280331(10)0000352746
• Combination Product (y/n): N
• Reporter Country Code: BU
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: W5-6-3-MVI
• Device Lot Number: 0000352746
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/19/2024
• Initial Date FDA Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2023
• 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
• Treatment: GUIDEWIRE - SYNCHRO; STENT - ATLAS; VIA-17 MICROCATHETER; WDC CONTROLLER
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 90 KG