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

Model Number 5513-001

Device Problem Mechanical Jam (2983)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/09/2022

Event Type  malfunction  

Manufacturer Narrative

A review of the device history record has been initiated.If any new, changed or corrected information is noted, a supplemental medwatch will be submitted.This is a known potential adverse event addressed in the product labeling.

Event Description

Healthcare professional reported a xen®45 gts event described as "blue slider would not slide forward and slide popped off" during implantation in right eye.Device not returned.Surgery was completed with backup xen®45 gts device.No eye injury noted.

Manufacturer Narrative

Device analysis: one xen 45 gts injector was received.The needle cover covered the needle, the needle plug and gel stent were not returned.The cam lock was received detached from the injector.The slider of the injector was not in the start position, but at the base of the injector and the bevel selector in the middle position with the needle retracted.Multiple points of damage were observed along both slider rails on the injector body.A functional test was performed.The slider knob was able to slide the full distance of the travel length in each of the three bevel selector positions with some resistance/interruption at the portion where the rails are damaged.The functional testing showed that the pusher rod which pushes the gel stent out of the needle performed correctly and the needle retracted properly as the slider knob was advanced to the end of the travel distance.The reported complaint of broken/damaged component and blocked slider is confirmed since damage was observed to the slider path on the injector body and slider resistance was observed during functional testing.The resistance observed during functional testing is likely due to the injector damage observed.It was found damage along the pathway of the slider where the cam lock was removed.The complaint issue was able to be recreated (i.E., obstructing the pathway) when twisting the cam lock to remove it rather than "grasping and pulling up." it¿s possible that the user technique in removing the cam lock was a contributing factor, however, there is insufficient information to make a definitive conclusion.Since there is no significant trend in this issue, no further investigation is required.However, it will continue to be tracked and trended.

Event Description

Healthcare professional reported a xen®45 gts event described as "blue slider would not slide forward and slide popped off" during implantation in right eye.Surgery was completed with backup xen®45 gts device.No eye injury noted.

• Brand Name: XEN 45 GTS
• Type of Device: IMPLANT, EYE VALVE
• Manufacturer (Section D): ALLERGAN (IRVINE); 2525 dupont drive; irvine CA 92612
• Manufacturer (Section G): ALLERGAN (IRVINE); 2525 dupont drive; irvine CA 92612
• Manufacturer Contact: terry ingram ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479366324
• MDR Report Key: 14806578
• MDR Text Key: 295485760
• Report Number: 3011299751-2022-00099
• Device Sequence Number: 1
• Product Code: KYF
• UDI-Device Identifier: 10888628032439
• UDI-Public: 10888628032439
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161457
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2022
• 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: 63995
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2022
• 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
• Patient Age: 86 YR
• Patient Sex: Male