MAUDE Adverse Event Report: NEW WORLD MEDICAL, INC. AHMED GLAUCOMA VALVE; GLAUCOMA SHUNT

Model Number	S2
Medical Device Problem Code	Physical Property Issue (3008)
Health Effect - Clinical Code	Intraocular Pressure, Delayed, Uncontrolled (1936)
Date of Event	06/20/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The dhr for the lot reported was reviewed and no issues were observed.The product was manufactured, inspected and released in compliance with our procedures.Customer reported she tied the tube off as the quickest and least traumatic procedure.Patient was unwilling for any further surgery and the eye is now effectively blind with corneal decompensation (though vision was poor pre-op) and iop is high but patient is comfortable on drops.Dr.Indicated she has been using these valves for many years and this is the first that has mis-performed in her hands.She has not changed her approach to surgery in any way.Valve was not explanted.
Event or Problem Description
"valve was faulty and over-drained from day 1 - we brought the patient back to the operating room (or) and tied it off.".

• Brand Name: AHMED GLAUCOMA VALVE
• Common Device Name: GLAUCOMA SHUNT
• Manufacturer (Section D): NEW WORLD MEDICAL, INC.; 10763 edison court; rancho cucamonga CA 91730
• MDR Report Key: 6427777
• Report Number: 1000125279-2017-00002
• Device Sequence Number: 943116
• Product Code: KYF
• UDI-Device Identifier: 00892064002133
• UDI-Public: (01)00892064002133(11)160430(17)180430(10)D0616
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K925636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/02/2017

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: Physician
• Device Expiration Date: 04/30/2018
• Device Model Number: S2
• Device Catalogue Number: S2
• Device Lot Number: D0616
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2017
• Initial Report FDA Received Date: 03/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Disability
• Patient Age: 82 YR