MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CERTAS INLIN VLV SPHN/UNIT CAT; CERTAS PLUS W/ SG

Catalog Number 828806

Device Problem Infusion or Flow Problem (2964)

Patient Problems Cerebral Ventriculomeglia (2133); Confusion/ Disorientation (2553)

Event Date 09/03/2020

Event Type  Injury  

Manufacturer Narrative

Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A facility reported that in (b)(6) 2020 the certas valve was implanted on a (b)(6) male patient via an l-p shunt with a setting of 4.However, the patient presented disorientation and cerebral ventricular enlargement was confirmed at the diagnostic imaging.So, the setting was lowered in steps from 4 to 3 to 2.On (b)(6) 2020, the patient¿s symptoms did not improve, and the setting was lowered to 1.On (b)(6) 2020, a contrast study confirmed that there was no flow from the valve.Therefore, the physician planned the replacement on (b)(6).No further information was provided by the hospital.

Manufacturer Narrative

Udi : (b)(4).The certas valve was returned for evaluation: failure analysis - the valve was visually inspected; needle holes in the needle chamber were noted.The valve passed the tests for programming, occlusion, leaks, reflux, siphon guard and pressure.No root cause could be determined for the problem reported by the customer as the technician could not confirm an occlusion with the valve at the time of investigation.The possible root cause for the issue reported by the customer could be due to biological debris and protein build up this could interfere with the valve mechanism, but at the time of investigation no occlusions were noted.

• Brand Name: CERTAS INLIN VLV SPHN/UNIT CAT
• 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: 10576836
• MDR Text Key: 208306182
• Report Number: 3013886523-2020-00119
• 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
• Type of Report: Initial,Followup
• Report Date: 09/03/2020

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 828806
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2020
• Initial Date Manufacturer Received: 09/03/2020
• Initial Date FDA Received: 09/23/2020
• Supplement Dates Manufacturer Received: 10/15/2020
• Supplement Dates FDA Received: 11/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 78 MO