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

Model Number UNKNOWN

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

Patient Problems Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)

Event Type  Injury  

Manufacturer Narrative

The device was implanted in the patient and not returned to the manufacturer for evaluation.Procedural and post-procedural images were not provided for review; therefore, the alleged product issue cannot be confirmed.A search for non-conformance's 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 ifu identifies neurological deficits as a potential complication associated with use of the device.

Event Description

As reported through the article titled, "post-market american experience with woven endobridge device adjudicated multicenter case series" multicenter registry analysis identified 91 patients across 6 institutions with attempted treatment of 91 aneurysms using the web device between 2019 and 2020.Post web deployment (date unknown), one patient was reported to have suffered either a new or worsened neurological deficit.The patient had to be taken back to the endovascular suite and was found to have an m2 occlusion.This was successfully managed with intracranial stenting following giib/iiia inhibitory load.

• Brand Name: WEB SL
• 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: 12072285
• MDR Text Key: 258693908
• Report Number: 2032493-2021-00256
• 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: 05/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/27/2021
• Initial Date FDA Received: 06/25/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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