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

Catalog Number 5513-001

Device Problem Difficult To Position (1467)

Patient Problem Eye Injury (1845)

Event Date 03/29/2018

Event Type  Injury  

Manufacturer Narrative

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.The event of incorrect placement is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.Further information from the reporter regarding patient details has been requested.No additional information is available at this time.Device labeling: precautions the patient¿s iop should be monitored postoperatively.If the iop is not adequately maintained after surgery, a therapeutic regimen or further intervention to reduce iop should be considered.Directions for use a properly placed xen®45 gel stent will have approximately 1 mm visible in the anterior chamber and approximately 2 mm visible in the subconjunctival space.The exit from the sclera should be approximately 3 mm from the limbus.A xen®45 gel stent that has a visible end in the anterior chamber and a visible end in the subconjunctival space should be considered properly implanted.Close the conjunctiva using a 10-0 vicryl or nylon suture.Viscoelastic should be irrigated and aspirated from the anterior chamber using either low power or using a manual arrangement.Viscoelastic may be re-entered into the anterior chamber to maintain anterior chamber depth.Additionally, after closure of the conjunctiva and removal of the viscoelastic, a bleb should form.Perform seidel testing to ensure there is no leakage of aqueous from the anterior chamber or conjunctiva.Should the final position of the xen®45 gel stent not be in the correct location (e.G., if the stent extends too far into the anterior chamber), the device may be exchanged.To exchange the device, grasp it near the point where it enters the angle.Gently pull the device away from the angle.Once you feel the stent move, release it and then grasp it again near the point where it enters the angle.Repeat this process until the stent is completely within the anterior chamber and can be removed through the corneal incision.The replacement stent should be implanted in the same quadrant or as near as possible to the original location of the removed stent using the same technique as implantation of the initial stent.If the xen®45 gel stent is positioned too far into the subconjunctival space, remove it through a small conjunctival incision using forceps.

Event Description

Healthcare professional reported xen implant is not fully draining due to incorrect placement.As an unsuccessful revision was attempted to fix the position of the gel stent on (b)(6) 2018, a 2nd xen was implanted.The affected xen remains implanted.

• 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: suzanne wojcik ; 301 w howard lane; suite 100; austin, TX 78753 ; 7372473605
• MDR Report Key: 7465724
• MDR Text Key: 106654907
• Report Number: 3011299751-2018-00054
• Device Sequence Number: 1
• Product Code: KYF
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2020
• Device Catalogue Number: 5513-001
• Device Lot Number: 61884
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2018
• 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