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 09/14/2022

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 initiated.If any new, changed or corrected information is noted, a supplemental medwatch will be submitted.

Event Description

Healthcare professional reported a xen®45 gts event described as injector jammed during implantation in "left" eye.Surgery was completed with second xen®45 gts device.No eye injury noted.

Manufacturer Narrative

Device analysis: the needle cover, retention plug and cam lock were not returned.The slider knob was received in the start position and the bevel selector in the center position.The gel stent was not returned.The needle and needle guide were observed to be bent.No other damage was observed.A large gap/ separation was observed between the halves of the syringe case (near the needle hub).Sample investigation for event code: blocked slider a visual inspection of the device was performed and no other damage was observed.The complainant did not report that injector was damaged.The condition of the injector is likely due to handling; therefore no further evaluation of the injector damage is required.A functional test per method id: cl-xen-01 could not be performed due to the condition of the injector.No further evaluation can be performed.Conclusion: the reported complaint condition of blocked slider is unable to confirm since a functional test cannot be performed due to the condition of the injector (damaged).No further evaluation can be performed.

Event Description

Healthcare professional reported a xen®45 gts event described as injector jammed during implantation in "left" eye.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: 15598888
• MDR Text Key: 303278073
• Report Number: 3011299751-2022-00166
• 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: 03/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2022
• 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: 63994
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/08/2021
• 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: 79 YR
• Patient Sex: Male
• Patient Ethnicity: Hispanic