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

Catalog Number	100300293
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
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.The manufacturer internal reference number is:(b)(4).
Event or Problem Description
A non-healthcare professional reported that following a glaucoma shunt implant procedure, the stent seemed to have been placed well.However, when it was advanced, it appeared to "bounce back" slightly.The decision was made to leave it as the stent seemed adequately advanced.On postoperative day one, the stent was visible at the slit lamp without gonioscopy and was protruding from the beginning of the first window.There was no notable contact with the iris or cornea, and the patient otherwise appeared stable, with an intraocular pressure (iop) of 7 mmhg.Additional information has been requested.
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 bounce back; 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: 20562052
• Report Number: 3016075957-2024-00050
• Device Sequence Number: 3102891
• Product Code: OGO
• UDI-Device Identifier: 00867487000134
• UDI-Public: 00867487000134
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P170034
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 100300293
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/03/2024
• Supplement Date Received by Manufacturer: 12/20/2024
• Initial Report FDA Received Date: 10/29/2024
• Supplement Report FDA Received Date: 01/13/2025
• 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
• Patient Age: 79 YR
• Patient Sex: Unknown