MAUDE Adverse Event Report: ALLERGAN (IRVINE) XEN 45 GTS; IMPLANT, EYE VALVE

Catalog Number 5513-001

Device Problems Malposition of Device (2616); Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/08/2019

Event Type  Injury  

Manufacturer Narrative

A review of the device history record has been initiated.If any deviations or non-conformances are found, a supplemental medwatch will be submitted.The event of incorrect placement is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.This is a known potential adverse event addressed in the product labeling.

Event Description

Healthcare professional reported a replacement was used due to xen®45 gts repositioning in the right eye.Surgery was completed with a 2nd xen®45 gts.There was no eye injury and device remains implanted.

Manufacturer Narrative

A review of the device history record has been initiated.If any deviations or non-conformances are found, a supplemental medwatch will be submitted.

Event Description

Additional information noted xen®45 gt curled and manipulated which pulled the xen®45 gt out of the ac.The device was explanted and events have been resolved.

• Brand Name: XEN 45 GTS
• Type of Device: IMPLANT, EYE VALVE
• Manufacturer (Section D): ALLERGAN (IRVINE); 2525 dupont drive; irvine CA 92612
• MDR Report Key: 9298318
• MDR Text Key: 165659572
• Report Number: 3011299751-2019-00269
• Device Sequence Number: 1
• Product Code: KYF
• Combination Product (y/n): N
• PMA/PMN Number: K161457
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Catalogue Number: 5513-001
• Device Lot Number: 62941
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention