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 12/01/2022

Event Type  malfunction  

Manufacturer Narrative

Further information regarding event, product, or patient details has been requested.No additional information is available at this time.A review of the device history record has been completed.No deviations or non-conformances noted.

Event Description

Healthcare professional reported a xen®45 gts event described as "safety tab hard to remove causing product not to slide smoothly.Tab very thick, injector got stuck." device did not make patient contact.Surgery was completed with second xen®45 gts device.No eye injury noted.

Manufacturer Narrative

Device analysis: one xen 45 gts enhanced injector was received.The molded tray was returned.The xen glaucoma treatment system (gts) unit box was returned.The injector was received with a black rubber needle guard attached to the injector.The needle cover, retention plug, and cam lock were not returned.The slider knob was in the end position and the bevel selector in the center position.The gel stent was not returned.A visual inspection of the device was performed.No atypical observations were made nor damage observed.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, and audible clicks were heard during the process.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.Since all of the expected conditions were met, no further evaluation is required.The reported complaint was not confirmed since no damage was observed and the injector met all of the expected conditions when functional testing was performed.

Event Description

Healthcare professional reported a xen®45 gts event described as "safety tab hard to remove causing product not to slide smoothly.Tab very thick, injector got stuck." device did not make patient contact.Surgery was completed with second 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: 16184949
• MDR Text Key: 308586089
• Report Number: 3011299751-2023-00003
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2023
• 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: 64056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2022
• 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