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).
[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
| Report Number | 3011299751-2020-00143 |
| MDR Report Key | 9907365 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2019-06-15 |
| Date Mfgr Received | 2020-03-05 |
| Device Manufacturer Date | 2019-01-02 |
| Date Added to Maude | 2020-03-31 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. MICHELLE BURGESS |
| Manufacturer Street | 12331-A RIATA TRACE PARKWAY BUILDING 3 |
| Manufacturer City | AUSTIN TX 78727 |
| Manufacturer Country | US |
| Manufacturer Postal | 78727 |
| Manufacturer Phone | 7372473605 |
| Manufacturer G1 | ALLERGAN (IRVINE) |
| Manufacturer Street | 2525 DUPONT DRIVE |
| Manufacturer City | IRVINE CA 92612 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92612 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | XEN 45 GTS |
| Generic Name | IMPLANT, EYE VALVE |
| Product Code | KYF |
| Date Received | 2020-03-31 |
| Catalog Number | 5513-001 |
| Lot Number | 62812 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALLERGAN (IRVINE) |
| Manufacturer Address | 2525 DUPONT DRIVE IRVINE CA 92612 US 92612 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-31 |