MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-24 for XEN 45 GTS 5507-001 manufactured by Allergan (irvine).
[187085571]
(b)(4). Further information from the reporter regarding product information has been requested. No additional information is available at this time. The events of endophthalmitis, exposure, high intraocular pressure, and fibrosis 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
[187085572]
Healthcare professional reported a patient had a xen 45 gel stent implanted with a combined cataract surgery in the left eye. Roughly two months later, the patient was seen in office with no issues other than the xen failure. The patient had endophtalmitis diagnosed about two weeks later in the left eye, secondary to an exposed device. Device was trimmed at the slit lamp when the exposure was noted. The endophtalmitis was "treated as per protocol, including oral steroids which may have affected systemic status vitreous tap grew haemophilus influenzae". The patient was admitted to the general medical ward roughly a week later. Two weeks after admission into the general ward the patient passed away due to a pulmonary embolism unrelated to the xen device. The device remained implanted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011299751-2020-00146 |
| MDR Report Key | 9876129 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-24 |
| Date of Report | 2020-03-24 |
| Date of Event | 2017-12-18 |
| Date Mfgr Received | 2020-02-23 |
| Date Added to Maude | 2020-03-24 |
| 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 | 2020-03-24 |
| Catalog Number | 5507-001 |
| Lot Number | NI |
| 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 | 2020-03-24 |