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

Model Number	S2
Medical Device Problem Codes	Device Issue (2379); Physical Property Issue (3008); Torn Material (3024)
Health Effect - Clinical Code	Intraocular Pressure, Delayed, Uncontrolled (1936)
Date of Event	01/25/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Without a lot number we are unable to complete a review of the device history record.The manufacturing process was reviewed and no issues were observed.Product is manufactured with validated procedures.All product is tested 100% prior to release.During steady state testing the returned valve was found to be in the low end of the specification.Upon visual inspection a tear was observed in the valve sheet.The tear in the valve likely accounts for the low steady state pressure that was measured during testing.Due to the presence of the tear.We were unable to determine if the valve had an impact on the high postoperative pressure reported by the customer.The customer reported the prescense of a well-formed bleb initially after surgery that was found to be flat at day 9.This indicates early postoperative flow through the valve and no flow through the device at day 9.It is unlikely that a valve malfunction was the cause of the rise in iop.Tear in the valve sheet would result in low pressure occurence.Possible causes of the flat bleb can be obstruction such as intraocular blood clots, fibrin clots, or incarcerated iris that may occlude the tube during or after surgery.Some blood was found in the device upon inspection.Blood was observed in the valve mechanism, but not in the fluid pathway.It is possible that the obstruction may have been flushed or washed off the device before it arrived for inspection.The ifu for the product was reviewed and it includes a warning that indicates "tampering with the valve can cause malfunctioning of the valve.".
Event or Problem Description
Patient has an agv implanted on (b)(6) 2018.On implantation dr.Thought the valve looked normal and was patent when primed.The procedure went smoothly and there were no complications.Patient returned on (b)(6) 2018 with a painful red eye with iop of 43mmhg in his operated eye.The anterior chamber was formed with moderate corneal edema.The valve was well secured under the conjunctiva.

• 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: 7343675
• Report Number: 1000125279-2018-00005
• Device Sequence Number: 16475205
• Product Code: KYF
• UDI-Device Identifier: 00892064002133
• UDI-Public: 00892064002133
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K925636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/13/2018

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 Model Number: S2
• Device Catalogue Number: S2
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2018
• Initial Report FDA Received Date: 03/15/2018
• 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