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

Catalog Number 5507-001

Device Problems Complete Blockage (1094); Malposition of Device (2616)

Patient Problems Eye Injury (1845); Uveitis (2122); Loss of Vision (2139)

Event Date 10/19/2023

Event Type  Injury  

Manufacturer Narrative

Continued d.10.Concomitant therapies: methotrexate, mycophenolate sodium.Continued h.6.Health effect - impact codes: e0830.Continued h.6.Health effect - impact codes: f2303.Article citation: evers, charlotte, et al.¿xen®-45 implantation for refractory uveitic glaucoma.¿ graefes archive for clinical and experimental ophthalmology, springer science+business media, oct.2023, https://doi.Org/10.1007/s00417-023-06254-3.Further information regarding event, product, or patient details has been requested.No additional information is available at this time.The event is a physiological complication and analysis of the device generally does not assist abbvie in determining a probable cause for this event.The events of hypotony maculopathy, macular edema, gel stent blockage, and device migration are a known potential adverse event addressed in the product labeling.

Event Description

Reported events of "25 eyes of 24 patients who underwent xen®45 gts ab interno implantation for medically uncontrolled uveitic glaucoma; 11 eyes had early hypotony (iop < 6 mmhg); 3 eyes had hypotony with hyperfiltration that persisted for more than 2 weeks and were provided contact lenses; 5 eyes had transient hypotony-related maculopathy; 3 eyes had choroidal effusions; 6 eyes required open conjunctival bleb revisions for impaired drainage due to stent occlusion in 5 eyes and iris contact with the stent in 1 eye; 1 eye required needling; 9 eyes had conjunctival injection or uveitis flare-up require topical steroid treatment up to hourly applications; 3 eyes had hypotony with flattened anterior chamber requiring atropine eye drops 1-2x/day; 1 eye with macular edema requiring topical, oral, and intravitreal steroids with oral valaciclovir; 5 eyes experienced iop spikes up to 40 mmhg, some requiring antiglaucoma medication; 6 eyes experienced a bcva loss of 2 lines or more by final follow up; 2 eyes experienced a bcva loss of less than 2 lines by final follow" were noted in the article: xen®-45 implantation for refractory uveitic glaucoma.Graefe's archive for clinical and experimental ophthalmology = albrecht von graefes archiv fur klinische und experimentelle ophthalmologie, 10.1007/s00417-023-06254-3.

• 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: 18076201
• MDR Text Key: 327484140
• Report Number: 3011299751-2023-00174
• Device Sequence Number: 1
• Product Code: KYF
• UDI-Device Identifier: 01240000000405
• UDI-Public: 1240000000405
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K161457
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 5507-001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: VALGANCICLOVIR, PREDNISOLONE, TOCILIZUMAB
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 55 YR