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 Code	Intraocular Pressure Increased (1937)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A product was not returned for analysis.Complaint history and product history record could not be reviewed because the reporting facility did not provide a valid lot number or any identification traceable to the manufacturing documentation.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.
Event or Problem Description
A physician reported that following an stent implant procedure, patient had increased intraocular pressure (iop) of 19 od.On gonioscopy, the stent was clearly plugged with tented-up iris tissue completely occluding the lumen of the portion of the stent exposed in the anterior chamber (ac).Additional information has been requested.There are two medical device reports associated with this patient.This report is associated with the right eye.

• 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: 20663702
• Report Number: 3016075957-2024-00054
• Device Sequence Number: 18200671
• Product Code: OGO
• UDI-Device Identifier: 00867487000134
• UDI-Public: 00867487000134
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P170034
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/12/2024

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/14/2024
• Initial Report FDA Received Date: 11/12/2024
• 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: 72 YR
• Patient Sex: Male