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

Catalog Number 5513-001

Device Problem Defective Component (2292)

Patient Problem No Patient Involvement (2645)

Event Date 06/04/2019

Event Type  malfunction  

Manufacturer Narrative

A review of the device history record has been initiated.If any deviations or non-conformance's are found, a supplemental medwatch will be submitted.Serial number (b)(4), lot number 62578.Device labeling: precautions: the xen®45 gel stent and xen® injector should be carefully examined in the operating room prior to use.

Event Description

Healthcare professional reported needle (retracting part of the needle) and gel stent are shorter than specification against the xen®45 gts.Surgery was completed with another xen.There was no patient contact, hence no eye injury.

Manufacturer Narrative

A review of the device history record has been completed.No deviations or non-conformances noted.Device evaluation: the needle was not able to sufficiently straighten and unable to be tested for actuation.The gel stent received was crinkled in the dry state.The implant was hydrated and there was no obstruction in the inner channel of the implant.The hydrated implant was measured to be within specification.The gel stent was crinkled in the dry stated, but once the implant was hydrated there were no issues with the gel stent.The initial condition of the implant suggest that the injector was actuated while the retention plug was still in the needle.The manufactured xen systems are 100% tested in-process and inspected at manufacturing.Allergan will continue to monitor the frequency of these complaints to determine if there is a trend or if this was an individual occurrence.

Event Description

Healthcare professional reported needle (retracting part of the needle) and gel stent are shorter than specification against the xen®45 gts.Surgery was completed with another xen.There was no patient contact, hence no eye injury.

• 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: 8756030
• MDR Text Key: 149930396
• Report Number: 3011299751-2019-00139
• 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: 09/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: 5513-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2019
• Date Manufacturer Received: 08/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other