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

Catalog Number	100300293
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Eye Injury (1845)
Date of Event	09/06/2024
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.The manufacturer internal reference number is: (b)(6).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 after glaucoma shunt implantation procedure, there was detachment of descemet membrane.He reported that it was the first time that the surgeon was using the microstent.He incised trabecular meshwork with the tip of a cannula and inserted it into schlemm canal.However, he felt that the cut was difficult, because the tip of the cannula was bigger than he expected or he felt the tip was not sharp but dull; it was too dull to make an incision.He considers that those factors would affect the detachment of descemet membrane.Currently there has been no treatment plan for the patient.Additional information was requested, but no further information is available.There are two medical device reports associated with this report.This is 2 of 2.
Additional Manufacturer Narrative
Additional information was provided in.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 after glaucoma shunt implantation procedure, there was detachment of descemet membrane.He reported that it was the first time that the surgeon was using the microstent.He incised trabecular meshwork with the tip of a cannula and inserted it into schlemm canal.However, he felt that the cut was difficult, because the tip of the cannula was bigger than he expected or he felt the tip was not sharp but dull; it was too dull to make an incision.He considers that those factors would affect the detachment of descemet membrane.Currently there has been no treatment plan for the patient.According to the additional information received, the affected eye was right eye.The patient had history of exfoliation glaucoma (primary disease) and cataract (concomitant disease).The patient condition has been recovering.The type of procedure performed was cataract surgery + glaucoma shunt insertion.There are two medical device reports associated with this report.This is 2 of 2.

• 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: 20369179
• Report Number: 3016075957-2024-00043
• Device Sequence Number: 12479812
• Product Code: OGO
• UDI-Device Identifier: 00867487000134
• UDI-Public: 00867487000134
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P170034
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2024

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: 16UDH4
• 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: 09/05/2024
• Supplement Date Received by Manufacturer: 10/08/2024
• Initial Report FDA Received Date: 10/04/2024
• Supplement Report FDA Received Date: 11/06/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 83 YR
• Patient Sex: Male