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 2020-03-27 for XEN 45 GTS 5513-001 manufactured by Allergan (irvine).
[186743683]
Article citation: gallardo, mark et. Al, "outcomes following implantation of an anterior segment drainage device xen45 gel stent) via an ab-interno or ab-externo approach in patients with uncontrolled open angle glaucoma. " further information from an author regarding event, product, or patient details has been requested. No additional information is available at this time. The events of exposure, device migration, and endophthalmitis are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events. [(b)(4)].
Patient Sequence No: 1, Text Type: N, H10
[186743684]
Company representative noted a poster containing details of the article "outcomes following implantation of an anterior segment drainage device xen45 gel stent) via an ab-interno or ab-externo approach in patients with uncontrolled open angle glaucoma" which noted serious adverse events with the xen 45 gel stent including 1 patient experienced endophthalmitis ; 3 patients experienced a xen was not in the ac (malpositioned) ; and 2 patients experienced an exposed xen.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011299751-2020-00159 |
| MDR Report Key | 9891781 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-27 |
| Date Mfgr Received | 2020-02-28 |
| Date Added to Maude | 2020-03-27 |
| 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 | 2020-03-27 |
| Catalog Number | 5513-001 |
| 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 | 2020-03-27 |