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

Catalog Number 5513-001

Device Problem Defective Component (2292)

Patient Problem No Patient Involvement (2645)

Event Date 05/14/2019

Event Type  malfunction  

Manufacturer Narrative

A review of the device history record has been initiated.If any deviations or non-conformance's are found, a supplemental medwatch will be submitted.Serial number (b)(4), lot number 62812.Device labeling: precautions: the xen®45 gel stent and xen® injector should be carefully examined in the operating room prior to use.

Event Description

Healthcare professional reported needle was shorter than specification against the xen®45 gts.There was no patient contact.Surgery was completed with another xen.

Event Description

Healthcare professional reported needle was shorter than specification against the xen®45 gts.There was no patient contact.Surgery was completed with another xen.

Manufacturer Narrative

A review of the device history record has been completed.No deviations or non-conformances noted.Device evaluation: the needle tip of the injector was measured against a certified ruler.The needle was measured at 3.5mm and were determined to be within the limits of the design specifications.For evaluation purposes in the irvine dal, the slider was tested for actuation.Results showed that slider knob was able to slide the full distance of the travel length, as tested multiple times in each of the three needle bevel selector positions.The functional testing showed that the pusher rod that pushes the gel stent out of the needle performed correctly and the needle retracted correctly as the slider knob was advanced to the end of the travel distance.The gel stent was not returned for further analysis.The reported complaint of the xen glaucoma treatment system was not confirmed.The returned unit needle tip was measured to be 3.5mm.There were no other anomalies observed.The manufactured xen systems are 100% tested in-process and inspected at manufacturing.Allergan will continue to monitor the frequency of these complaints to determine if there is a trend or if this was an individual occurrence.

• Brand Name: XEN 45 GTS
• Type of Device: IMPLANT, EYE VALVE
• Manufacturer (Section D): ALLERGAN (IRVINE); 2525 dupont drive; irvine CA 92612
• MDR Report Key: 8746953
• MDR Text Key: 149641294
• Report Number: 3011299751-2019-00145
• Device Sequence Number: 1
• Product Code: KYF
• Combination Product (y/n): N
• PMA/PMN Number: K161457
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 09/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: 5513-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2019
• Date Manufacturer Received: 08/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other