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

Catalog Number 828804

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Date 02/19/2021

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 facility reported that the anti-siphon of the certas valve does not seem to be working and it was replaced with a certas plus inline valve without siphon guard.

Manufacturer Narrative

Additional information received: the valve was implanted on a 51-year-old female on (b)(6) 2020.On (b)(6) 2020 the valve setting was changed from 6 to 5 and on (b)(6) 2020, the patient presented with "postural headache (minor non orthostatic headaches early (b)(6)), further reduction 5>4 declined / visual oscillation / ct showed significant empty ventricles", and the setting was changed from 5 to 6.On an unknown date, the patient ¿"presented acutely with full parinaud syndrome and over dilated ventricles / valve tapped with needle manometer but pressure subatmospheric unable to flow spontaneously until withdrawn with syringe / extensive periventricular and callosal signal change at this time on mri which persists with evolution of parkinsonian features".The valve was explanted on 2021.

Event Description

N/a.

Manufacturer Narrative

The certas valve was returned for evaluation: dhr: lot number 4235807, conformed to the specifications when released to stock.Failure analysis: the position of the cam when valve was received was at setting 3.The valve was visually inspected; needle holes in the needle chamber were noted.The valve was hydrated.The valve was leak tested and only leaked from the needle hole in the needle chamber.The valve passed the test for programming, occlusion, reflux, siphon guard and pressure.No root cause could be determined as the technician could not confirm any functional problem with the valve at the time of investigation.The possible root cause for the issue reported by the customer was probably due to biological debris and protein build up interfering with the valve mechanism, at the time of investigation no functional issues were noted.

Event Description

N/a.

• 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: 11477666
• MDR Text Key: 239721544
• Report Number: 3013886523-2021-00107
• 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,Followup
• Report Date: 05/05/2021

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: 828804
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2021
• Initial Date Manufacturer Received: 02/22/2021
• Initial Date FDA Received: 03/12/2021
• Supplement Dates Manufacturer Received: 03/10/2021; 04/16/2021
• Supplement Dates FDA Received: 03/24/2021; 05/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 51 YR