MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CERTAS INLIN VLV ONLY W/SPHNGD; CERTAS PLUS W/ SG

Catalog Number 828804

Device Problem Obstruction of Flow (2423)

Patient Problem Injury (2348)

Event Date 11/24/2020

Event Type  Injury  

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A physician reported that the certas valve was implanted to a patient via v-p shunt on an unknown date and unknown setting for the treatment of a brain tumor.A week after placement, it was difficult to change the setting.Patient's hydrocephalus symptoms did not improve thus obstruction was suspected.On (b)(6) 2020, revision surgery was performed and valve was replaced with a new one.After removing the valve, the flow patency was verified and obstruction was not confirmed.The patient's protein concentration was high.

Manufacturer Narrative

Unique device identification (udi) - (b)(4).The valve was returned for evaluation: failure analysis - the position of the cam when valve was received was at setting 1.The valve was visually inspected; needle holes in the needle chamber was noted.The valve passed the test for programming, occlusion, reflux, siphon guard and pressure.The valve only leaked from the needle hole in the needle chamber.No root cause could be determined as the technician could not confirm any problem with the valve at the time of investigation.The possible root cause for the issue reported by the customer could be due biological debris and protein buildup interfering with the valve mechanism, at the time of the investigation no occlusions/programming issues were noted.

• Brand Name: CERTAS INLIN VLV ONLY W/SPHNGD
• Type of Device: CERTAS PLUS W/ SG
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• MDR Report Key: 10987788
• MDR Text Key: 220901296
• Report Number: 3013886523-2020-00244
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K143111
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 11/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 828804
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• Date Manufacturer Received: 01/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 94 YR