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

Model Number FP7

Device Problem Failure to Prime (1492)

Patient Problem Intraocular Pressure, Delayed, Uncontrolled (1936)

Event Date 04/29/2014

Event Type  Injury  

Event Description

Dr.(b)(6) was unable to prime valve (b)(4) (lot h0112).The doctor reported using surgical tool to rip the internal valve sheet to allow flow.Damaging the internal valve sheet to allow flow.Damaging the internal sheet prevents the valve from functioning normally.The patient experienced persistent low iop until the valve was explanted on (b)(6) 2014.The patient currently has high iop with no implant planned in the near future.

Manufacturer Narrative

Waiting on further information from doctor.The results of the investigation are pending.The patient is currently back to pre-operative iop with no surgery planned in the near future.

• Brand Name: AHMED GLAUCOMA VALVE
• Type of Device: GLAUCOMA SHUNT
• Manufacturer (Section D): NEW WORLD MEDICAL, INC.; rancho cucamonga CA
• Manufacturer Contact: cristina avalos ; 10763 edison ct.; rancho cucamonga, CA 91730 ; 9094664304
• MDR Report Key: 3853507
• MDR Text Key: 4412762
• Report Number: 1000125279-2014-00003
• Device Sequence Number: 1
• Product Code: KYF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K925636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2017
• Device Model Number: FP7
• Device Catalogue Number: FP7
• Device Lot Number: H0112
• Other Device ID Number: NOT APPLICALBE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/29/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ANTI-INFLAMMATORY MEDICATION; IOP LOWERING MEDICATION
• Patient Outcome(s): Required Intervention