MAUDE Adverse Event Report: MICROVENTION, INC WEB SL 17 SINGLE LAYER; INTRASACCULAR FLOW DISRUPTION DEVICE

Model Number W5-4.5-2-MVI-3

Device Problem Difficult or Delayed Separation (4044)

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

Event Date 03/21/2024

Event Type  malfunction  

Manufacturer Narrative

Procedure/medical information review: a detailed medical review of the procedure notes dated (b)(6)2024 has been completed for complaint.As reported through the clinical study complex aneurysm registry (car), on(b)(6) 2024, the patient received treatment (transcatheter embolization) for a superior hypophyseal right intracranial aneurysm of an unruptured sidewall aneurysm using a web sl 4.5x2mm device.On the same day of performance of the procedure (b)(6) 2024 and during the performance of the procedure, the physician reported that the device was detached with slight sticky tether.Follow-up angiogram projection indicates stable device position.Data review indicates that benchmark was retracted into the cervical ica, and a final whole head angiogram was performed with post-operative diagnosis described as postoperative successful embolization.These images showed aneurysm occlusion, no thromboemboli and no change in cerebral perfusion.Based on the review and in my medical opinion, data review indicates that the web sl 4.5x2mm device was deployed with a relationship associated to the described slight sticky tether.No patient injury and of harm was reported associated with this case.Investigation findings: 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.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: 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 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.Warnings ¿ advance and retract the web embolization device slowly.Do not advance the delivery device with excessive force.Determine the cause of any unusual resistance.Remove the web embolization device if excessive friction is noted and check for damage.¿ do not rotate the delivery device during or after delivery of the web embolization device.Rotating the web embolization device may result in damage or premature detachment.¿ the web embolization device cannot be detached with any other power source other than a web detachment control device.Ensure that at least two web detachment control devices are available before initiating an embolization procedure - instructions for use detachment of the web embolization device 34.The detachment control device is pre-loaded with batteries and will activate when the delivery device is properly connected.35.Verify that the rhv is firmly locked around the delivery device before attaching the detachment control device to ensure that the web embolization device does not move during the connection process.36.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.37.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.38.Verify the web embolization device position before pressing the detachment button.39.Push the detachment button.During firing, the light should be solid green and the beep should be continuous.40.Verify detachment by first loosening the rhv valve, then pulling back slowly on the delivery device and verifying that there is not web embolization device movement.If the web embolization device does not detach, push the detachment button again.If the web embolization 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.41.Verify the position of the web embolization device angiographically through the guide catheter.42.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 web embolization device remains within the microcatheter.Investigation conclusion: a medical review of the provided procedure notes was performed.As reported through the clinical study complex aneurysm registry (car), on(b)(6) 2024, the patient received treatment (transcatheter embolization) for a superior hypophyseal right intracranial aneurysm of an unruptured sidewall aneurysm using a web sl 4.5x2mm device.On the same day of performance of the procedure and during the performance of the procedure, the physician reported that the device was detached with slight sticky tether.Follow-up angiogram projection indicates stable device position.Data review indicates that the benchmark catheter was retracted into the cervical ica, and a final whole head angiogram was performed with post-operative diagnosis described as postoperative successful embolization.These images showed aneurysm occlusion, no thromboemboli and no change in cerebral perfusion.The data provided in the procedure notes indicates that the web sl 4.5x2mm device was deployed with a relationship associated to the described slight sticky tether.However, 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.

Event Description

As reported through the clinical study complex aneurysm registry (car): during intracranial aneurysm treatment of an unruptured sidewall aneurysm using the web device for the car registry on (b)(6) 2024 there was slight sticky tether of web sl w5-4.5-2.There was no other treatment/intervention needed as a result of the malfunction.The web was used and remains implanted.A via 17 catheter was used.Per the clinical site there was no impact to the patient and the deficiency did not lead to an ade.Dsa imaging done (b)(6) 2024 shows 100 percent aneurysm angiographic occlusion (b)(6) occlusion classification (rroc): class 3.Parent artery patency: widely patent.Web occlusion scale (wos): wos b.Index aneurysm recurrence? no.Redacted procedure note indicated: procedure(s): 1.Transcatheter embolization, cns: superior hypophyseal right ica aneurysm ((b)(6)) 2.Transcatheter therapy, embolization, radiological supervision and interpretation ((b)(6)) 3.Selective catheter placement, right internal carotid artery, with angiography of the intracranial carotid circulation ((b)(6)) 4.Angiography through existing catheter for follow-up study for transcatheter therapy, embolization ((b)(6)) 5.3d rendering requiring image postprocessing on an independent workstation ((b)(6)) 6.Ultrasound guidance for vascular access: right common femoral artery access ((b)(6)) pre-operative diagnosis (indication): superior hypophyseal right ica aneurysm post-operative diagnosis: same, status post successful embolization.95 cm benchmark catheter was used to selectively catheterize the right internal carotid artery.Dsa imaging of the cranial vessels was performed.3d rotational angiography was also performed.3d images were generated and reviewed on an independent workstation for treatment planning.Initial angiography confirmed a 4 mm superior hypophyseal right ica aneurysm.A 90 degree via (b)(4) microcatheter was used to select the aneurysm lumen over a synchro 14 wire.A web sl 4.5x2 mm device was deployed.A follow-up angiogram through the existing benchmark showed aneurysm occlusion without significant parent artery encroachment.The device was then detached with only a slight sticky tether.Another follow-up angiogram in the working projection showed stable device position.The benchmark was retracted into the cervical ica, and a final whole head angiogram was performed.These images showed aneurysm occlusion, no thromboemboli and no change in cerebral perfusion.Hemostasis was achieved using a 6f angioseal device.

• Brand Name: WEB SL 17 SINGLE LAYER
• Type of Device: INTRASACCULAR FLOW DISRUPTION DEVICE
• Manufacturer (Section D): MICROVENTION, INC; 35 enterprise; aliso viejo CA 92656
• Manufacturer (Section G): MICROVENTION, INC; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 19122119
• MDR Text Key: 341049651
• Report Number: 2032493-2024-00301
• Device Sequence Number: 1
• Product Code: OPR
• UDI-Device Identifier: 00842429110799
• UDI-Public: (01)00842429110799(11)240213(17)270131(10)0000514351
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: W5-4.5-2-MVI-3
• Device Lot Number: 0000514351
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/25/2024
• Initial Date FDA Received: 04/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/13/2024
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 90 DEGREE VIA 17 MICROCATHETER; PENUMBRA, BENCHMARK 071, 6FX.071"X95CM; STRYKER, SYNCHRO SELECT, 014" X 215CM; SYNCHRO 14 WIRE; TERUMO ANGIOSEAL VIP - 6F