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

Model Number MV-WB070421

Device Problem Difficult or Delayed Separation (4044)

Patient Problem Brain Injury (2219)

Event Date 06/03/2021

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 discarded at the user facility and not returned to the manufacturer for evaluation.Procedural images and post procedural images were not provided for review; therefore, the alleged product issue cannot be confirmed.

Event Description

It was reported that during treatment of an aneurysm, a web device did not detach fully from its delivery pusher after attempted detachment with a controller.The delivery pusher was withdrawn while advancing the microcatheter and the web was detached.The microcatheter pushed the web into the aneurysm and caused an aneurysm neck remnant.A gooseneck snare was used to remove the web, however these manipulations caused a minor embolic cerebral infarction in the right middle cerebral artery region and edaravone was administered.The patient is in rehabilitation.

• 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; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 12105632
• MDR Text Key: 259636315
• Report Number: 2032493-2021-00271
• Device Sequence Number: 1
• Product Code: OPR
• UDI-Device Identifier: 04987892122378
• UDI-Public: (01)04987892122378(11)200910(17)230831(10)20091011G
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P170032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: MV-WB070421
• Device Lot Number: 20091011G
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/08/2021
• 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): Required Intervention; Disability