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

Catalog Number 5513-001

Device Problems Partial Blockage (1065); Difficult To Position (1467); Deformation Due to Compressive Stress (2889)

Patient Problems Hemorrhage/Bleeding (1888); Hyphema (1911); Intraocular Pressure Increased (1937)

Event Date 11/13/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Further information from the reporter 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.Analysis of the device generally does not assist allergan in determining a probable cause for the reported physiological complications.Device labeling: 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.In order to minimize trauma to the eye and associated complications, it is essential that the gel implant is placed in the proper subconjunctival location.Warnings the following may occur in conjunction with the use of the xen gel implant: gel implant migration, gel implant exposure or extrusion, gel implant blockage, choroidal effusion or hemorrhage, hypotony maculopathy, bleb related complications, or endophthalmitis and other known complications of intraocular surgery (e.G., flat or shallow chamber, hyphema, corneal edema, macular edema, retinal detachment, vitreous hemorrhage, uveitis).

Event Description

Healthcare professional reported after many attempts to reposition the xen in the right eye, it still was not connected.No bleb and not visible in ac.The physician needed a second xen, which was successful with no issues.There was no eye injury at this time.It was further noted that the second xen was needed due to the first one being curled.Postoperatively, patient developed microhyphema, clotted blood, vitreous hemorrhage, bleb flat with pigment noted along tracts of both stents (one of which was curled and the other straight), and iop of 42 which led to restarting drops.Treatment was provided as ppv/ac washout with retina and eventually the decision was made for baerveldt tube implant, which was performed approximately 2 months post xen implant.The patient was on aspirin and oral diclofenac for chronic hip pain prior to implant surgery.Physician further noted "the distal (subconj) end of both implanted xen stents seems to be covered in pigment which suggests that the xen stent (or the needle of the delivery device) somehow penetrated pigmented tissue during deployment.If this same pigmented tissue was also vascular, then it could have caused bleeding." healthcare professional stated the vitreous hemorrhage and hyphema seem to have resolved and the patient's iop is better (20 mm hg and will be lower in a few weeks when the baerveldt implant opens).Patient has developed a very dense pco in the right eye, possibly contributing to the poor visual acuity.Planned treatment is noted as "to do yag capsulotomy in the future, but probably not for a couple of months." both devices remain implanted.This is the same event and the same patient reported under mdr id# 3011299751-2018-00023 ((b)(4)).This is the first mdr submitted for the first implanted xen 45 gts.

• 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: 7236303
• MDR Text Key: 98840840
• Report Number: 3011299751-2018-00022
• 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: 02/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Catalogue Number: 5513-001
• Device Lot Number: 61657
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2018
• 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
• Patient Age: 70 YR