MAUDE Adverse Event Report: OPTONOL LTD. EX-PRESS GLAUCOMA FILTRATION DEVICE; IMPLANT, EYE VALVE

Model Number P-50 PL

Device Problems Occlusion Within Device (1423); Malposition of Device (2616); No Flow (2991)

Patient Problem Intraocular Pressure, Delayed, Uncontrolled (1936)

Event Date 01/28/2018

Event Type  Injury  

Manufacturer Narrative

Product evaluation: no data regarding product identity was received i.E.No lot or serial number were indicated for the event; therefore, the device history record (dhr) could not be reviewed.The product was returned for investigation and received in the following manner: only the device was received for investigation in a plastic cup.During initial inner illumination test, blockage of the lumen was found, therefore the reported complaint was confirmed.After cleaning the shunt inner lumen was found to be open; there is no indication for any manufacturing relating factors that could cause the reported event.All products pass 100% final inspection at the manufacturer prior to approval.If a defect would be noticed, the product would have been rejected.Shunt touching iris: previous similar complaints indicate that such an event is transient and does not cause harm to the patient.Having said that, one may conclude that the blockage was formed after the product left the manufacturing plant.The root cause is inconclusive - unable to verify, the root cause could not be conclusively determined since the blockage could have been caused by many different reasons after the clinical procedure.The blockage does not seem to be product related since after the shunt cleaning the blockage was removed.(b)(4).

Event Description

A doctor reported that following a glaucoma filtration device (gfd) implant procedure, he suspected that the device was clogged.The patient 's intraocular pressure did not decrease one week following the procedure.The patient was transferred to a hospital where it was confirmed that aqueous humor was not flowing from the device.It was also noted that the tip of the device touched the iris.The device was removed and a trabeculectomy was performed.Additional information was requested.

Manufacturer Narrative

(b)(4).

Event Description

Additional information was provided that cataract surgery was performed during the same procedure as the device implantation.The causality of the event could be the device.The possibility of another reason for the event is yes.It could be due to constitution and condition that fibrin tends to appear.One day following the implant procedure the intraocular pressure did not lower and the previous doctor decided there was device obstruction.A yag laser was used to try to correct the occlusion.The intraocular pressure did not change, so the patient was hospitalized and surgery was performed.Four days following the implant procedure, the device was touching the iris.A laser was performed to release the iris.The device was removed and a trabeculectomy was performed.

• Brand Name: EX-PRESS GLAUCOMA FILTRATION DEVICE
• Type of Device: IMPLANT, EYE VALVE
• Manufacturer (Section D): OPTONOL LTD.; kiryat hatikshoret; communication center; neve-ilan 90850 ; IS 90850
• MDR Report Key: 7326925
• MDR Text Key: 101989318
• Report Number: 3003701944-2018-00018
• Device Sequence Number: 1
• Product Code: KYF
• Combination Product (y/n): N
• PMA/PMN Number: K012852
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 05/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: P-50 PL
• Device Catalogue Number: 60053
• Device Lot Number: ASKU
• Other Device ID Number: 380650705013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2018
• Date Manufacturer Received: 04/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 87 YR