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

Model Number W4-4-S-MVI-3

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Extravasation (1842); Intracranial Hemorrhage (1891)

Event Date 03/21/2021

Event Type  Injury  

Manufacturer Narrative

A search for non-conformances associated with the device's 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 in the patient and was not returned to the manufacturer for evaluation.Additionally, procedural images were not provided; therefore, the reported event cannot be confirmed.The instructions for use (ifu) identifies emboli, ischemia, and clot formation as a potential complications associated with use of the device.

Event Description

It was reported that a web device was implanted in an aneurysm of the right anterior communicating artery.Control angiograms performed before and after detachment confirmed that there was no encroachment of the web device on the daughter vessels after deployment and flow in all distal branches was normal.The final control angiographic run raised concern that the web may have been occluding the ipsilateral a2 segment and limiting flow, which had not been visualized in the two previous runs post detachment.The physician attempted to catheterize the ipsilateral a2 several times unsuccessfully with a guide wire and microcatheter.The physician then appeared to cross a completely different artery, the patient's anterior communicating artery, effectively traveling from the patient's right a1 to the left a1.The intermediate catheter was then advanced into the origin of the anterior communicating artery.A stent was placed from the anterior communicating artery to the patient's right a1.A control run was performed, demonstrating extravasation of the anterior communicating artery where the intermediate catheter was previously.An occlusion balloon was then placed at the same location and inflated.After deflation, the extravasation continued, forcing the physician to access the left a1 via the left ica and place coils.At no time did the web 4 device or the catheter which it was delivered through come into contact with the anterior communicating artery, which was the rupture site.

• Brand Name: WEB SLS
• Type of Device: INTRASACCULAR FLOW DISRUPTION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise drive; aliso viejo, CA 92656
• MDR Report Key: 11691585
• MDR Text Key: 246425544
• Report Number: 2032493-2021-00145
• Device Sequence Number: 1
• Product Code: OPR
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: W4-4-S-MVI-3
• Device Catalogue Number: W4-4-S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2020
• 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): Life Threatening; Required Intervention