ISTENT TRABECULAR MICRO BYPASS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-01-16 for ISTENT TRABECULAR MICRO BYPASS manufactured by Glaukos Corporation.

Event Text Entries

[189009518] Mean and mode used. The device was not available; therefore, product testing on the actual device could not be performed. The device identifiers were not provided; therefore, the device history records for this device lot number could not be reviewed. A review of the device labeling was completed. Iris damage is identified in the labeling as known inherent risks of trabecular micro-bypass stent procedure. The ifu adequately provides instructions for stent implantation, precautions, and warnings for the proper use and handling of the device. Based on the information received, the root cause of the reported event was due to patient movement (patient related). Mfr# reference: (b)(4).
Patient Sequence No: 1, Text Type: N, H10

[189009519] The following was reported through a review of an article tittled "outcomes of trabecular micropbypass surgery: comparison of resident trainees and attending surgeons". Reportedly, one (1) month postoperatively there was one (1) case of iridodialysis. The one case of 5 clock hour iridodialysis during microbypass stent implantation occurred in the resident group when the patient suddenly moved her head while the injector was in the eye. An intraoperative decision was made not to implant the stent. At the most recent follow-up 17 months postop, the patient had an iop of 14 mm hg with two glaucoma medications. She did not have prolonged postoperative inflammation, hemorrhage, or long-term complications other than the appearance of the eye. The patient was offered repair of the iridodialysis for cosmetic purposes but declined. Any omitted information was not available at the time of this report. Additional information has been requested, but has not been received. Please see the attached article for further details.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2032546-2020-00011
• MDR Report Key: 9599152
• Report Source: COMPANY REPRESENTATIVE,HEALTH
• Date Received: 2020-01-16
• Date of Report: 2020-01-16
• Report Date: 2005-01-01
• Date Reported to FDA: 2005-01-01
• Date Reported to Mfgr: 2005-01-10
• Date Mfgr Received: 2019-12-23
• Date Added to Maude: 2020-01-16
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MRS. BRITTANY MASSEY
• Manufacturer Street: 229 AVENIDA FABRICANTE
• Manufacturer City: SAN CLEMENTE CA 92672
• Manufacturer Country: US
• Manufacturer Postal: 92672
• Manufacturer Phone: 949367960
• Manufacturer G1: GLAUKOS CORPORATION
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: ISTENT TRABECULAR MICRO BYPASS
• Generic Name: INTRAOCULAR PRESSURE LOWERING IMPLANT
• Product Code: OGO
• Date Received: 2020-01-16
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: GLAUKOS CORPORATION
• Manufacturer Address: 229 AVENIDA FABRICANTE SAN CLEMENTE CA 92672 US 92672

Device Sequence Number: 101

• Brand Name: ACETAMINOPHEN 500MG
• Product Code: ---
• Date Received: 2020-01-16
• Device Sequence No: 101
• Device Event Key: 0
• Manufacturer: MANUFACTURE / COMPOUNDER NAME

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other; 2. Required No Informationntervention	2020-01-16