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 2020-03-25 for XEN 45 GTS (AUSTRALIA) 5517-001 manufactured by Allergan (irvine).
[188648381]
Further information from the reporter regarding event details has been requested. No additional information is available at this time. The event of incorrect placement is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.
Patient Sequence No: 1, Text Type: N, H10
[188648382]
Healthcare professional reported during a xen 45 gel stent implant in the left eye, they were not successful in exiting through the sclera and implanting the xen into the sub-conjunctival space. The xen could be observed in the anterior chamber but was not evident in the sub conjunctival space. Several attempts were made to remove the xen from the anterior chamber with ilm forceps but the xen could not be grasped. Healthcare professional decided to convert the case to a trabeculectomy which was performed successfully. The xen remains in the patient? S eye with a portion within the anterior chamber and the remainder lodged in ocular tissue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011299751-2020-00145 |
| MDR Report Key | 9878078 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-25 |
| Date of Event | 2020-02-25 |
| Date Mfgr Received | 2020-02-25 |
| Device Manufacturer Date | 2019-12-13 |
| Date Added to Maude | 2020-03-25 |
| 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 (AUSTRALIA) |
| Generic Name | IMPLANT, EYE VALVE |
| Product Code | KYF |
| Date Received | 2020-03-25 |
| Catalog Number | 5517-001 |
| Lot Number | 63069 |
| 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 | 2020-03-25 |