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

Model Number	FP8
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Intraocular Pressure Increased (1937); Intraocular Pressure Decreased (4468)
Date of Event	08/12/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Distributor reported, "this valve was implanted on (b)(6) 2022, but it did not reduce the patient's iop.This valve was then explanted and replaced with another fp-8.The surgeon assumes the cause could be malfunction of the valve.".
Additional Manufacturer Narrative
The device history record for the lot involved was reviewed and no issues were observed.Product was manufactured, tested, and released per validated procedures.Explanted valve was returned and underwent visual inspection and functional testing.Bodily fluid observed on device during visual inspection but valve appears undamaged.No other issues found with the device.State pressure test was also conducted on the unit to mimic the physiological flow conditions of the human eye, where the resulting pressure in the system measured and yielded passing results.The returned valve met the acceptance criteria and performed as expected.The issue of high iop condition as reported by customer could not be replicated or confirmed.
Additional Manufacturer Narrative
Distributor originally reported issue as, "this valve was implanted on (b)(6) 2022, but it did not reduce the patient's iop.This valve was then explanted and replaced with another fp-8.The surgeon assumes the cause could be malfunction of the valve".After submission, distributor provided a correction to the report stating, "after implantation of fp8, low iop was observed and continued, so it was replaced with another fp8".Results from original investigation are still applicable; the returned valve underwent functional testing and met the acceptance criteria.

• Brand Name: AHMED GLAUCOMA VALVE
• Common Device Name: GLAUCOMA DRAINAGE DEVICE
• Manufacturer (Section D): NEW WORLD MEDICAL, INC.; 10763 edison court; rancho cucamonga CA 91730
• Manufacturer (Section G): NEW WORLD MEDICAL, INC.; 10763 edison court; rancho cucamonga CA 91730
• Manufacturer Contact: cristina avalos ; 10763 edison court; rancho cucamonga, CA 91730 ; 9098705446
• MDR Report Key: 15420388
• Report Number: 1000125279-2022-00034
• Device Sequence Number: 2544959
• Product Code: KYF
• UDI-Device Identifier: 00892064002126
• UDI-Public: (01)00892064002126(11)211024(17)231024(10)L0721
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K980657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2022

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 Expiration Date: 10/24/2023
• Device Model Number: FP8
• Device Catalogue Number: FP8
• Device Lot Number: L0721
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2022
• Supplement Date Received by Manufacturer: 08/22/2022
• Initial Report FDA Received Date: 09/14/2022
• Supplement Report FDA Received Date: 10/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian