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

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

Patient Problem Aneurysm (1708)

Event Type  Injury  

Event Description

As reported through the article titled, "woven endobridge versus stent-assisted coil embolization of cerebral bifurcation aneurysms" a retrospective single-center study was performed that comprised of 63 bifurcation aneurysms that were treated endovascularly with web devices between 2011 and 2019.Of those 63 cases, 6 patients were reported to have aneurysm remnants at 6 months, 2 patients' at 12 months and 7 patients during the final assessment visit.

Manufacturer Narrative

The lot number was not provided; therefore, the device history records could not be reviewed and a lot history trending review could not be performed.The device was not returned to the manufacturer for analysis; therefore, the alleged product issue cannot be confirmed.If the device or additional information is received, the investigation will be performed and a supplemental mdr report will be submitted.Article bibliography: el naamani, kareem, et al."woven endobridge versus stent-assisted coil embolization of cerebral bifurcation aneurysms." journal of neurosurgery 1.Aop (2022): 1-8.

• 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
• MDR Report Key: 14458844
• MDR Text Key: 292193029
• Report Number: 2032493-2022-00203
• 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: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/03/2022

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/03/2022
• Initial Date FDA Received: 05/20/2022
• 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): Other