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

Catalog Number	100300293
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Codes	Macular Edema (1822); Intraocular Pressure Increased (1937); Uveitis (2122)
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: sachdeva n.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 august 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.This file was created for a 75-year-old female with a history of bilateral chronic angle closure glaucoma and age-related macular degeneration was referred for chronic granulomatous uveitis with elevated iop after cataract surgery with hydrus microstent implantation in the left eye 8 months prior.The patient complained of no improvement in vision after the surgery and had a history of recurrent inflammation on tapering topical steroids.Showed cme with a central macular thickness of 405 micrometer.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.Sachdeva n, 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.
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 intraocular pressure, chronic granulomatous uveitis, remove the microstent, and central macular thickness of 405 micrometre; 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: 20406727
• Report Number: 3016075957-2024-00044
• Device Sequence Number: 19677827
• 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?: No
• 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: 10/09/2024
• 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: 75 YR
• Patient Sex: Female