XEN 45 GTS

Report

Report Number: 3011299751-2021-03098
Event Type: Injury
Date Received: September 22, 2021
Date of Event: August 17, 2021
Report Date: September 22, 2021
Manufacturer: ALLERGAN (IRVINE)
Product Code: KYF
PMA / PMN Number: K161457
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: NY, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

ARTICLE CITATION: DANGDA, SONAL, ET AL. ¿OPEN CONJUNCTIVAL APPROACH FOR SUB-TENON¿S XEN GEL STENT PLACEMENT AND BLEB MORPHOLOGY BY ANTERIOR SEGMENT OPTICAL COHERENCE TOMOGRAPHY.¿ JOURNAL OF GLAUCOMA, VOL. PUBLISH AHEAD OF PRINT, 2021. CROSSREF, DOI:10.1097/IJG.0000000000001929. CLARIFICATION TO AGE OR DATE OF BIRTH: MEAN AGE WAS 69.4 ± 8.0 YEARS. CLARIFICATION TO IMPLANT DATE: IMPLANT DATES RANGE 2016 THROUGH (B)(6) 2018. (B)(4). THE EVENT OF HIGH INTRAOCULAR PRESSURE IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. MULTIPLE REQUESTS FOR FURTHER INFORMATION HAVE BEEN MADE. ALLERGAN HAS RECEIVED NO RESPONSE FROM THE AUTHORS.

Description of Event or Problem · 1

REPORTED EVENTS OF 2 EYES WITH IOP SPIKE > 30 MMHG ON POSTOPERATIVE DAY 1, ONE OF THESE EYES WAS DUE TO VISCOELASTIC IN THE ANTERIOR CHAMBER AND BLOOD CLOT BLOCKING THE TUBE LUMEN; 1 EYE UNDERWENT NEEDLING AT POSTOPERATIVE WEEK 3, WHICH SHOWED EVIDENCE OF AN OCCLUSION OF THE DISTAL END OF THE IMPLANT TIP; 1 EYE UNDERWENT NEEDLING AT POSTOPERATIVE WEEK 6, THEN REQUIRED PLACEMENT OF A GLAUCOMA DRAINAGE IMPLANT (GDI) AT POSTOPERATIVE MONTH 7; WERE NOTED IN THE ARTICLE "OPEN CONJUNCTIVAL APPROACH FOR SUB-TENON'S XEN GEL STENT PLACEMENT AND BLEB MORPHOLOGY BY ANTERIOR SEGMENT OPTICAL COHERENCE TOMOGRAPHY" JOURNAL OF GLAUCOMA, EPUB AHEAD OF PRINT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1410389	XEN 45 GTS	IMPLANT, EYE VALVE	KYF	ALLERGAN (IRVINE)		NI

Patients

Seq	Age	Sex	Outcome	Treatment
1	69 YR		Required Intervention