XEN 45 GTS 5513-001

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-31 for XEN 45 GTS 5513-001 manufactured by Allergan (irvine).

Event Text Entries

[186824337] (b)(4). A review of the device history record has been initiated. If any deviations or non-conformances are found, a supplemental medwatch will be submitted. The reported events of decreased va due to low eye pressure, choroidal effusion, encapsulated bleb, decreased iop, and elevated intraocular pressure are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.
Patient Sequence No: 1, Text Type: N, H10


[186824338] Healthcare professional reported a clinical patient experienced decreased va due to low eye pressure, choroidal effusion, dacryocystitis (not device related), decreased iop, conjunctival encapsulated bleb in the right eye against the xen? 45 gts. Patient underwent injection of air into anterior chamber, revision of bleb with restriction suture and bandage contact lens, 5 fu injection, needling procedure, and anterior chamber washout. Patient then experienced elevated iop and was treated with glaucoma valve ahmed fp7 and vision graft. All reported events have been recovering/resolving. The device remains implanted.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3011299751-2020-00143
MDR Report Key9907365
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2019-06-15
Date Mfgr Received2020-03-05
Device Manufacturer Date2019-01-02
Date Added to Maude2020-03-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMRS. MICHELLE BURGESS
Manufacturer Street12331-A RIATA TRACE PARKWAY BUILDING 3
Manufacturer CityAUSTIN TX 78727
Manufacturer CountryUS
Manufacturer Postal78727
Manufacturer Phone7372473605
Manufacturer G1ALLERGAN (IRVINE)
Manufacturer Street2525 DUPONT DRIVE
Manufacturer CityIRVINE CA 92612
Manufacturer CountryUS
Manufacturer Postal Code92612
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameXEN 45 GTS
Generic NameIMPLANT, EYE VALVE
Product CodeKYF
Date Received2020-03-31
Catalog Number5513-001
Lot Number62812
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerALLERGAN (IRVINE)
Manufacturer Address2525 DUPONT DRIVE IRVINE CA 92612 US 92612


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-31

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