HYDRUS® MICROSTENT
Report
- Report Number
- 3016075957-2021-00051
- Event Type
- Injury
- Date Received
- December 1, 2021
- Date of Event
- November 1, 2021
- Report Date
- March 28, 2022
- Manufacturer
- IVANTIS INC.
- Product Code
- OGO
- UDI-DI
- 00867487000134
- PMA / PMN Number
- P170034
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE HYDRUS MICROSTENT REMAINS IMPLANTED IN THE PATIENT AND IS NOT AVAILABLE FOR EVALUATION. THE DEVICE LOT NUMBER IS UNKNOWN; THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE CONDUCTED. DEVICE IDENTIFIERS HAVE BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE FILED IF NEW INFORMATION IS RECEIVED. HYPHEMA, ELEVATED IOP, AND BLURRY VISION ARE LISTED IN THE INSTRUCTIONS FOR USE AS POTENTIAL ADVERSE EVENTS. MANUFACTURER REFERENCE #: (B)(4).
THE HYDRUS MICROSTENT REMAINS IMPLANTED IN THE PATIENT AND IS NOT AVAILABLE FOR EVALUATION. THE DEVICE LOT NUMBER IS UNKNOWN; THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE CONDUCTED. DEVICE IDENTIFIERS HAVE BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE FILED IF NEW INFORMATION IS RECEIVED. HYPHEMA, ELEVATED IOP, AND BLURRY VISION ARE LISTED IN THE INSTRUCTIONS FOR USE AS POTENTIAL ADVERSE EVENTS. MANUFACTURER REFERENCE #: (B)(4).
SECTION H6: INCLUDED HEALTH EFFECT CLINICAL CODE 1937 - INTRAOCULAR PRESSURE INCREASED. MANUFACTURER REFERENCE #: (B)(4).
THE PATIENT UNDERWENT CATARACT SURGERY WITH AB-INTERNO CANALOPLASTY FOLLOWED BY HYDRUS MICROSTENT IMPLANTATION. THE PATIENT WAS ON ORAL ANTICOAGULANT THERAPY WHICH WAS DISCONTINUED PRIOR TO SURGERY. ON POST-OPERATIVE DAY 1, THE PATIENT PRESENTED WITH IOP OF 35 MMHG (ON THREE IOP-LOWERING MEDICATIONS) AND A SMALL INFERIOR-NASAL LAYERED HYPHEMA WITH 4+ RED BLOOD CELLS. IN OFFICE, THE PATIENT RECEIVED DOSING OF 3 IOP-LOWERING MEDICATIONS WHICH RESULTED IN LOWERED IOP TO 30MMHG AT SUBSEQUENT FOLLOW-UP; VISION FLUCTUATED OVER THE NEXT FEW DAYS. AT 1-WEEK FOLLOW-UP, THE HYPHEMA WAS RESOLVING AND THE MEDICATED IOP WAS NOTED TO BE THE SAME AS THE NONOPERATIVE FELLOW EYE.
THE PATIENT UNDERWENT CATARACT SURGERY WITH AB-INTERNO CANALOPLASTY FOLLOWED BY HYDRUS MICROSTENT IMPLANTATION. THE PATIENT WAS ON ORAL ANTICOAGULANT THERAPY WHICH WAS DISCONTINUED PRIOR TO SURGERY. ON POST-OPERATIVE DAY 1, THE PATIENT PRESENTED WITH IOP OF 35 MMHG (ON THREE IOP-LOWERING MEDICATIONS) AND A SMALL INFERIOR-NASAL LAYERED HYPHEMA WITH 4+ RED BLOOD CELLS. IN OFFICE, THE PATIENT RECEIVED DOSING OF 3 IOP-LOWERING MEDICATIONS WHICH RESULTED IN LOWERED IOP TO 30MMHG AT SUBSEQUENT FOLLOW-UP; VISION FLUCTUATED OVER THE NEXT FEW DAYS. AT 1-WEEK FOLLOW-UP, THE HYPHEMA WAS RESOLVING AND THE MEDICATED IOP WAS NOTED TO BE THE SAME AS THE NONOPERATIVE FELLOW EYE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1805000 | HYDRUS® MICROSTENT | INTRAOCULAR PRESSURE LOWERING IMPLANT | OGO | IVANTIS INC. | F00022 | 00867487000134 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Male | Required Intervention | ANTICOAGULANT - ELIQUIS (UNKNOWN DOSAGE AND DATES) |