MAUDE Adverse Event Report: IVANTIS INC HYDRUS MICROSTENT; INTRAOCULAR PRESSURE LOWERING IMPLANT

Catalog Number	100300293
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Intraocular Pressure Increased (1937); UGH (Uveitis Glaucoma Hyphema) Syndrome (4470)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.Literature citation: n.Sachdeva et al., early to late explantation of hydrus microstent migs device: a case series: american journal of ophthalmology case reports 2024 jul 20;36:102105, 1-4.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A health care professional published original article with a purpose early to late explantation of hydrus microstent migs device: a case series.The hydrus micros tent was approved by the fda in (b)(6) 2018 for use with cataract surgery to reduce iop in patients with mild to moderate primary open angle glaucoma (poag).Pivotal clinical trials demonstrated its overall safety and efficacy in lowering iop.However, mispositioning of the implant can result in uveitis glaucoma- hyphemia (ugh) syndrome necessitating device explantation.Here we report four such cases and their associated challenges.We also highlight the importance of early recognition of post-operative complications for ease of implant removal.A 71-year-old man with poag on dual anti-platelet therapy (aspirin and clopidogrel) presented with persistent hyphema and uncontrolled iop after the hydrus implant.During his cataract and hydrus implant surgery, significant bleeding was noted from the initial goniotomy site for hydrus insertion, and additional viscoelastic was able to tamponade the bleed intraoperatively.In the post-operative period, the patient developed a large hyphema and nasal clot with an iop of 64 mmhg and was started on oral acetazolamide.Clopidogrel was stopped after consulting the cardiologist, but aspirin 81 mg was continued.The patient continued to have hyphema with uncontrolled iop on maximal medical therapy.B-scan was negative for posterior segment hemorrhage.The patient underwent anterior chamber washout with hydrus explantation and ahmed glaucoma valve implantation 16 days after the first surgery.Intraoperatively, the proximal end of the implant was surrounded by peripheral anterior synechiae and iris tissues.It was pulled free using a sinsky hook, and a hydrus deployer was used to retract the implant into the anterior chamber and out of the eye.On pod 1, iop was 11 mmhg with visual acuity of hand motion and no hyphema, but vitreous hemorrhage was noted.The patient was started on prednisolone acetate four times daily with a gradual taper.By 5 months, the vitreous hemorrhage had cleared with improvement in visual acuity to 20/40, and iop was 15 mmhg on medication.This case highlights that patients with hydrus implants treated with anti-platelet therapy may be at higher risk for persistent hyphema in cases of implant malposition.Conclusion: hydrus micros tents that are mispositioned can result in persistent uveitis-glaucomahyphema syndrome.Explantation between 2 weeks and 11 months successfully resolved post-operative uveitis and hyphemia, but all cases required additional glaucoma-hyphemia syndrome.Early recognition is important since late removal was more challenging due to the implant becoming embedded in the iris.
Additional Manufacturer Narrative
Additional information was provided in h.3., h.6.And h.11.A sample was not received at investigation site for evaluation for the report of persistent hyphema, uncontrolled intraocular pressure, microstent explantation, implant was surrounded by peripheral anterior synechiae and iris tissues; therefore, the condition of the product could not be verified.No lot number was identified with this complaint; therefore, a device history record review could not be conducted.A sample was not received at the investigation site and no lot information is available, therefore, the root cause for the customer complaint issue cannot be determined.The manufacturer internal reference number is: (b)(4).

• Brand Name: HYDRUS MICROSTENT
• Common Device Name: INTRAOCULAR PRESSURE LOWERING IMPLANT
• Manufacturer (Section D): IVANTIS INC; 201 technology drive; irvine CA 92618
• Manufacturer (Section G): IVANTIS INC; 201 technology drive; irvine CA 92618
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 20415701
• Report Number: 3016075957-2024-00047
• Device Sequence Number: 8202781
• Product Code: OGO
• UDI-Device Identifier: 00867487000134
• UDI-Public: 00867487000134
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P170034
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Literature,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 100300293
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/12/2024
• Supplement Date Received by Manufacturer: 12/09/2024
• Initial Report FDA Received Date: 10/10/2024
• Supplement Report FDA Received Date: 01/02/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male