MAUDE Adverse Event Report: MICROVENTION INC. MICROVENTION MICROVENTION WEB IMPLANT (WEB 21 SL 6X3) PART NUMBER W4-6-3, SIZE 6; INTRASACCULAR FLOW DISRUPTION DEVICE

Lot Number 200714127

Device Problems Entrapment of Device (1212); Failure to Disconnect (2541); Difficult or Delayed Activation (2577)

Patient Problems Failure of Implant (1924); Brain Injury (2219); Obstruction/Occlusion (2422); Device Embedded In Tissue or Plaque (3165); Thrombosis/Thrombus (4440)

Event Date 07/25/2022

Event Type  Death  

Event Description

A 52-year-old patient underwent vascular embolization of a ruptured left anterior communicating aneurysm using the microvention web device.Four different attempts were made to implant web devices.During the last two attempts, the device could not be detached from its detachment wire although successfully situated within the aneurysm.The first device whose detachment failed was removed, and a second was placed that also failed to detach.After the second attempt, the wire was secured, with part retained in the patient.The wire is meant to detach and not be retained in the patient.The patient's left aca (anterior cerebral artery) then required stenting due to occlusion.The physician reported that it is unknown if the inability to detach the devices contributed to further clotting and occlusion of the artery near the aneurysm, which may have led to a stroke and further neurological issues.The patient suffered irreparable brain injury and expired.Fda safety report id# (b)(4).

• Brand Name: MICROVENTION MICROVENTION WEB IMPLANT (WEB 21 SL 6X3) PART NUMBER W4-6-3, SIZE 6
• Type of Device: INTRASACCULAR FLOW DISRUPTION DEVICE
• Manufacturer (Section D): MICROVENTION INC.
• MDR Report Key: 15121306
• MDR Text Key: 296851288
• Report Number: MW5111148
• Device Sequence Number: 3
• Product Code: OPR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 07/25/2022
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Lot Number: 200714127
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Treatment: SOFIA EX 5F 115CM PART NUMBER ISC5115ST, LOT: 0000120283.; VIA 17 MICROCATHETER PART NUMBER VIA-17-154-01, LOT: 0000180428.; VIA 21 MICROCATHETER PART NUMBER VIA-21-154-01, LOT: 200721121M.; WEB DETACHER PART NUMBER WDC-2, LOT: 21011411B.; WEB IMPLANT (WEB 17 SL 6X3) PART NUMBER W5-6-3, SIZE 6MM X3MM, LOT: 0.
• Patient Outcome(s): Death