XEN 45 GTS
Report
- Report Number
- 3011299751-2022-00156
- Event Type
- Injury
- Date Received
- September 30, 2022
- Date of Event
- August 30, 2022
- Report Date
- November 18, 2022
- Manufacturer
- ALLERGAN (IRVINE)
- Product Code
- KYF
- UDI-DI
- 10888628032439
- PMA / PMN Number
- K161457
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
(B)(4). ARTICLE CITATION: WANG, AND WANG. ¿SUPRACHOROIDAL HEMORRHAGE AFTER XEN GEL IMPLANT REQUIRING SURGICAL DRAINAGE.¿ JOURNAL OF CURRENT GLAUCOMA PRACTICE, VOL. 16, NO. 2, AUG. 2022, PP. 132¿35. HTTPS://DOI.ORG/10.5005/JP-JOURNALS-10078-1378. FURTHER INFORMATION REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE EVENT IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT.
CLARIFICATION TO H.4.: (B)(6). 2020. 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.
THE ARTICLE: "WANG K, WANG JC, SARRAFPOUR S. SUPRACHOROIDAL HEMORRHAGE AFTER XEN GEL IMPLANT REQUIRING SURGICAL DRAINAGE." J CURR GLAUCOMA PRACT 2022; 16 (2):132-135, REPORTED A CASE STUDY NOTING THE FOLLOWING EVENTS. PATIENT UNDERWENT XEN®45 GTS PLACEMENT IN THE LEFT EYE VIA THE AB-EXTERNO APPROACH. ON POD 1, IOP WAS 4 MMHG, BCVA DECREASED FROM 20/30 TO 20/80, AND CHOROIDAL EFFUSIONS WERE NOTED. ON POD 2, VISION WORSENED, IOP WAS 9 MMHG, AND PROGRESSION TO SUPRATEMPORAL SUPRACHOROIDAL HEMORRHAGES (SCHS) WERE NOTED. ON POD 3, PATIENT WOKE-UP, COUGHED, AND EXPERIENCED 10/10 EYE PAIN. IOP WAS 41 MMHG, BCVA WAS 20/100, A HYPHEMA, A SMALL HORSESHOE TEAR NASALLY AND WORSENED TEMPORAL AND NASAL SCH WERE NOTED. ANTIGLAUCOMA MEDICATIONS WERE PROVIDED BUT THE EVENT PROGRESSED TO KISSING CHOROIDALS HAD OCCURRED BY POSTOPERATIVE WEEK 1. BY THE END OF WEEK 1, BCVA WAS AT HAND MOTION LEVEL AND IOP WAS 5 MMHG. LASER BARRICADE OF THE TEAR WAS UNSUCCESSFULLY ATTEMPTED. LATER, LIQUEFACTION OF THE CHOROIDALS WAS FOUND REQUIRING SURGICAL INTERVENTION. THE PATIENTS ANTICOAGULATION MEDICATION (RIVAROXABAN) WAS HELD FOR THE SURGERY AND UNDERWENT A SUCCESSFUL SCLEROTOMY WITH RETINAL CRYOPEXY TO RESOLVE THE LIQUEFACTION AND THE TEAR. DAY 1 AFTER TREATMENT, IOP WAS 7 MMHG, BCVA WAS COUNTING FINGERS, AND THE RIVAROXABAN CONTINUED TO BE WITHHELD. 1 WEEK AFTER TREATMENT, THE PATIENT WENT TO THE EMERGENCY DEPARTMENT FOR A TRANSIENT ISCHEMIC ATTACK (TIA) AND THE RIVAROXABAN WAS RESTARTED. BY 2 MONTHS AFTER TREATMENT WITH PHYSICAL THERAPY, BVCA IMPROVED TO 20/40 WITH RESOLUTION OF THE SCHS, IOP WAS WELL-CONTROLLED AT 10 MMHG WITHOUT ANTIGLAUCOMA MEDICATIONS. NO FURTHER CEREBRAL VASCULAR ACCIDENTS EPISODES NOTED. THE EVENT OF THE TIA HAS BEEN DEEMED NOT DEVICE RELATED.
ADDITIONAL INFORMATION REPORTED MOXIFLOXACIN DROPS, PREDNISOLONE DROPS, ATROPINE DROPS WERE USED DURING POSTOPERATIVE WEEK 1. ON POD 3, LASER BARRICADE OF THE TEAR WAS COMPLETED WITH ADDITIONAL REINFORCEMENT BEING PERFORMED ON POD 12. ON POD 8, LIQUEFACTION OF THE CHOROIDAL WAS FOUND REQUIRING SURGICAL INTERVENTION. POD 12 UNDERWENT A SUCCESSFUL SCLEROTOMY WITH RETINAL CRYOPEXY TO RESOLVE THE LIQUEFACTION AND THE TEAR. THE PATIENT PRESENTED TO THE ER TWICE WITH A TRANSIENT ISCHEMIC ATTACK (TIA), 9 DAYS AND 25 DAYS AFTER SURGICAL TREATMENT, AND THE RIVAROXABAN WAS RESTARTED. 57 DAYS AFTER SURGICAL TREATMENT WITH PHYSICAL THERAPY, BVCA IMPROVED TO 20/40 WITH RESOLUTION OF THE SCHS, IOP WAS WELL-CONTROLLED AT 10 MMHG WITHOUT ANTIGLAUCOMA MEDICATIONS. EVENT RESOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1747902 | XEN 45 GTS | IMPLANT, EYE VALVE | KYF | ALLERGAN (IRVINE) | 5513-001 | 63211 | 10888628032439 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 86 YR | Male | Required Intervention | RIVAROXABAN |