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

Catalog Number 5513-001

Device Problem Mechanical Jam (2983)

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

Event Date 10/05/2022

Event Type  malfunction  

Manufacturer Narrative

Device analysis: the retention plug and cam lock were each detached and not returned.The slider of the injector was not in the start position and was partially advanced.The needle was partially retracted, and the bevel was in the center position.A visual evaluation of the xen injector was performed.No damage/ defects were observed.To evaluate device functionality, the injector was tested for actuation.The slider knob was able to slide the full distance of the travel length in each of the three bevel selector positions.Functional testing showed that the pusher rod which pushes the gel stent out of the needle performed correctly, and the needle moved in tandem with the slider knob.The needle was fully extended as the slider knob was at the start position, and the needle retracted properly as the slider knob was advanced to the end of the travel distance.The gel stent deployed from the needle during functionality testing.Resistance was not observed.Clicks were heard.The reported complaint of blocked slider is not confirmed since the slider knob was able to slide the full distance of the travel length of each of the three bevel selector positions and since resistance was not observed during functional testing.The gel stent was able to be deployed from the needle during functionality testing.A review of the device history record has been completed.No deviations or non-conformances noted.The event is a known potential adverse event addressed in the product labeling.

Event Description

Healthcare professional reported a xen®45 gts event described as xen was stuck in the injector during implantation in left eye.Surgery was completed with second xen®45 gts device.No eye contact 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: 18423298
• MDR Text Key: 331876982
• Report Number: 3011299751-2023-00184
• 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
• Report Date: 01/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/01/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5513-001
• Device Lot Number: 63995
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2022
• 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: 70 YR
• Patient Sex: Female
• Patient Weight: 98 KG
• Patient Ethnicity: Non Hispanic