MAUDE Adverse Event Report: ALLERGAN XEN STENT; IMPLANT, EYE VALVE

Model Number XEN45

Device Problems Break (1069); Defective Device (2588); Activation, Positioning or Separation Problem (2906)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/02/2019

Event Type  Injury  

Event Description

Defective xen stent.Xen stent fell apart and could not reload, another stent used.

• Brand Name: XEN STENT
• Type of Device: IMPLANT, EYE VALVE
• Manufacturer (Section D): ALLERGAN
• MDR Report Key: 8616163
• MDR Text Key: 145481570
• Report Number: MW5086691
• Device Sequence Number: 1
• Product Code: KYF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: No Information
• Type of Report: Initial
• Report Date: 05/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: XEN45
• Device Catalogue Number: 5513-001
• Device Lot Number: 62812
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR