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

Model Number W5-5-3-MVI-3

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Muscle Weakness (1967)

Event Date 08/15/2023

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 was implanted and therefore not available for return and investigation by the manufacturer.However, medical records were provided and the documentation review and investigation is ongoing.Upon completion of the investigation, a supplemental mdr will be submitted.

Event Description

It was reported through the web pas clinical trial that the patient experienced right sided weakness after treatment with a web for an unruptured lica terminus aneurysm 6x4mm.Post procedure, the subject developed right upper extremity weakness and right sided numbness.A ct head showed a combination of a small amount of subarachnoid hemorrhage and extravasated contrast in the left supratentorial compartment.A repeat ct head on one day post procedure showed resolution of the previously noted subarachnoid hemorrhage.There was no evidence of thromboembolic complications or significant flow restriction.The patient was discharged from the hospital five days post op.

Event Description

N/a.

Manufacturer Narrative

Procedure note medical review conclusion for complaint (b)(4): data review indicated that the procedure was completed successful with web embolization utilizing the 5x3 web sl 17 with noted good flow stagnation.A review of the physician operative report dictation data does not provide evidence that a device malfunction occurred with the selected web device and there is no evidence upon review of the physician operative report dictation data that a web device malfunction contributed to the reported right upper extremity weakness and right-side numbness.Review of the physician operative report dictation data further indicates that web sl 17 5 x 3 was successfully placed in the aneurysm and follow-up angiography showed only trace bulging at the neck with no significant compromise of the a1 or m1 segments of the anterior and middle cerebral arteries respectively.There was good stagnation in the aneurysm.In addition, review of the physician operative report dictation data further indicates that the performance of a 3d dyna ct showed good positioning of the web device within the aneurysm and good wall apposition without significant compromise of the adjacent vessels.Without the return and physical evaluation of the device, the investigation is unable to determine if a condition existed that would have caused or contributed to the reported event.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 include but are not limited to the following: vessel puncture site hematoma, aneurysm perforation or rupture, hemorrhage, edema, thromboemboli, transient ischemic attack, ischemic stroke, neurologic deficits, parent artery occlusion, ischemia, vessel dissection or perforation, vascular thrombosis, vasospasm, device migration or misplacement, premature detachment, headache, post-embolization syndrome, infection 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.

• Brand Name: WEB SL
• Type of Device: INTRASACCULAR DEVICES
• Manufacturer (Section D): MICROVENTION, INC.; 35 entrprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 17741458
• MDR Text Key: 323353371
• Report Number: 2032493-2023-00934
• Device Sequence Number: 1
• Product Code: OPR
• UDI-Device Identifier: 00842429110850
• UDI-Public: (01)00842429110850(11)211012(17)240930(10)0000094802
• 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,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: W5-5-3-MVI-3
• Device Lot Number: 0000094802
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2023
• 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
• Patient Age: 53 YR
• Patient Sex: Female