FDA Adverse Event Injury Summary report: N

XEN 45 GTS

MDR report key: 8285467 · Received January 29, 2019

Report

Report Number: 3011299751-2019-00016
Event Type: Injury
Date Received: January 29, 2019
Date of Event: October 15, 2018
Report Date: January 29, 2019
Manufacturer: ALLERGAN (IRVINE)
Product Code: KYF
PMA / PMN Number: K161457
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: UK
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

KARRI, BHAVANI, ET AL. "ENDOPHTHALMITIS FOLLOWING XEN STENT EXPOSURE." JOURNAL OF GLAUCOMA, VOL. 27, NO. 10, OCTOBER 2018, P.931-933. (B)(4). CONCOMITANT MEDICAL PRODUCTS: PF CHLORAMPHENICOL 0.5%, PREDNISOLONE ACETATE, AND "BETAMETHASOME" SODIUM PHOSPHATE 0.01% OINTMENT ADDED AT NIGHT. THE REPORTED EVENTS OF INFLAMMATION/IRRITATION, ENDOPHTHALMITIS, VISION LOSS, HIGH INTRAOCULAR "PRESSUR", HYPOPYON, OCULAR PAIN AND EXPOSURE ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. FURTHER INFORMATION FROM THE REPORTER REGARDING THE EVENT AND PRODUCT HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. DEVICE LABELING: THIS IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING.

Description of Event or Problem · 1

REPORTED EVENTS OF ENDOPHTHALMITIS AND RED EYE ASSOCIATED WITH REDUCED VISION, PAIN, DIARRHEA AND VOMITING 4 MONTHS POST XEN IMPLANTED IN THE LEFT EYE THAT MIGHT BE DUE TO MICROTRAUMA OF THE CONJUNCTIVA OCCURRED DURING INITIAL IMPLANTATION OF XEN AND LATER CAUSED THE TIP OF XEN TO BE EXPOSED WERE NOTED IN THE ARTICLE "ENDOPHTHALMITIS FOLLOWING XEN STENT EXPOSURE." JOURNAL OF GLAUCOMA, VOL. 27, NO. 10, OCTOBER 2018, P.931-933.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
79542	XEN 45 GTS	IMPLANT, EYE VALVE	KYF	ALLERGAN (IRVINE)		NI

Patients

Seq	Age	Sex	Outcome	Treatment
1	89 YR		Required Intervention	PF PREDNISOLONE ACETATE 0.5%