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 2020-03-18 for XEN 45 GTS 5507-001 manufactured by Allergan (irvine).
[183959412]
(b)(4). Further information from the reporter regarding event has been requested. No additional information is available at this time. The events of fibrosis, keratitis, device migration, vision loss, high intraocular pressure and conjunctival hyperthermia are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these 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
[183959413]
Healthcare professional patient with a xen 45 gel stent in the left eye has need several needlings due to a tension result unsatisfactory. In a gonioscopy, the xen implant is found on the left side in an intra-cameral and probably intra-scleral position and the distal end is no longer in a sub-conjunctival position probably due to significant fibrosis and progressive slipping of the device. It was noted "the implant is troublesome, leads to a decrease of the vision and endothelitis. " under local anesthesia, "decision to remove the xen because malposition in anterior chamber with marked conjunctival hyperhemia and realization of a deep filtering sclerectomy. No intra- or post-operative complications.?
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011299751-2020-00102 |
| MDR Report Key | 9849550 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-18 |
| Date of Report | 2020-03-18 |
| Date of Event | 2020-01-15 |
| Date Mfgr Received | 2020-02-17 |
| Device Manufacturer Date | 2018-04-18 |
| Date Added to Maude | 2020-03-18 |
| 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 | 2020-03-18 |
| Catalog Number | 5507-001 |
| Lot Number | 62380 |
| 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 | 2020-03-18 |