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

Catalog Number 5507-001

Device Problem Malposition of Device (2616)

Patient Problems Eye Injury (1845); Loss of Vision (2139); Fibrosis (3167)

Event Date 07/03/2023

Event Type  Injury  

Manufacturer Narrative

Clarification to d.6a.: december 2015 - may 2017.Clarification to h.6.Health effect - clinical code: e2402, e0827, e0802.Continued h.6.Health effect - impact codes: f23, f0101, f15.Article citation: busch t, skiljic d, rudolph t, bergström a, zetterberg m.Four-year outcome of xen 45 gel stent implantation in a swedish population.Clinical ophthalmology, 2023 jul 3, volume 17, 1897¿1910.Https://doi.Org/10.2147/opth.S412400.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.

Event Description

Reported events of "4 eyes had cataract surgery due to iris incarceration; 2 eyes with complete visual field loss; 16 eyes had transient hypotony (<7 mmhg); 18 eyes with transient hyphema; 2 eyes with prolonged hyphema which later resolved; 1 eye with fibrin and corneal edema; 16 eyes with increased iop (>30 mmhg); 45 eyes required needling; 11 eyes with shallow anterior chamber, of which 1 received ovd fill-up and 1 received yag iridotomy; 14 eyes with choroidal detachment; 1 eye with epithelial defect; 20 eyes with incorrectly implanted (misplaced) stents: 13 were entrapped in iris tissue of which 1 resolved after yag iridotomy, 1 was in contact with endothelium which was later explanted; 4 eyes with encapsulated blebs required surgical treatment, of which 1 had intraoperative damage to the stent resulting in trabeculectomy; 1 eye with conjunctival leakage/avascularity requiring surgical treatment; 31 eyes required other surgical intervention, of which 1 was cyclodiode laser treatment" were noted in the article: "four-year outcome of xen 45 gel stent implantation in a swedish population." clinical ophthalmology (auckland, n.Z.) vol.17 1897-1910.This is the same article reported under mdr report#: 3011299751-2023-00115 (abbvie complaint#: (b)(4).

• 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: 17419541
• MDR Text Key: 320024106
• Report Number: 3011299751-2023-00114
• Device Sequence Number: 1
• Product Code: KYF
• UDI-Device Identifier: 01240000000405
• UDI-Public: 1240000000405
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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: 07/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2023
• 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: 07/11/2023
• 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
• Patient Outcome(s): Required Intervention; Disability