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 2020-03-19 for XEN 45 GTS 5513-001 manufactured by Allergan (irvine).
[189046561]
Further information from the reporter regarding event and device details has been requested. No additional information is available at this time. The events of high intraocular pressure, fibrosis, and endophthalmitis are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for the events. A review of the device history record has been initiated. If any new, changed or corrected information is noted, a supplemental medwatch will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[189046562]
Healthcare professional reported a patient with a xen 45 gel stent had needling occur a few days following implant in the left eye. Roughly two months later, it was noted the patient had endophthalmitis. The device was removed and to treat the eye there needed to be 6 intravitreal injections with vancomycin. Removal and treatment was carried out by a retina specialist. Endophthalmitis is now sterile, but some fibrin and inflammation remains present.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011299751-2020-00137 |
| MDR Report Key | 9856590 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-19 |
| Date of Event | 2019-12-17 |
| Date Mfgr Received | 2020-02-19 |
| Device Manufacturer Date | 2019-11-13 |
| Date Added to Maude | 2020-03-19 |
| 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 | 2020-03-19 |
| Catalog Number | 5513-001 |
| Lot Number | 63044 |
| 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 | 2020-03-19 |