MAUDE Adverse Event Report: ALLERGAN, INC. XEN GLAUCOMA TREATMENT SYSTEM; IMPLANT, EYE VALVE

Model Number 5513-001

Device Problem No Flow (2991)

Patient Problem Insufficient Information (4580)

Event Date 08/09/2021

Event Type  malfunction  

Event Description

Patient was scheduled for a cataract removal with i stent placement.The i stent was opened and the md stated that there was "no flow" with the device.Another i stent was opened and the case was completed without further incident.Failed device will be sent to materials management to be sent back to manufacturer for facility credit.Will monitor for trends with device.

• Brand Name: XEN GLAUCOMA TREATMENT SYSTEM
• Type of Device: IMPLANT, EYE VALVE
• Manufacturer (Section D): ALLERGAN, INC.; 301 w howard lane suite 100; austin TX 78753
• MDR Report Key: 12487501
• MDR Text Key: 271898520
• Report Number: 12487501
• Device Sequence Number: 1
• Product Code: KYF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5513-001
• Device Catalogue Number: 5513-001
• Device Lot Number: 540052
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/08/2021
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 09/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 28105 DA