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

Catalog Number 828806

Device Problem Obstruction of Flow (2423)

Patient Problem Memory Loss/Impairment (1958)

Event Date 03/01/2021

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 physician reported the certas valve was implanted to a (b)(6) year old female patient via v-p shunt on (b)(6) 2020 with setting 4.The course went well after the operation, but in (b)(6) 2020, the patient presented with memory impairment and the setting was changed to 3 with no improvement, and even though the setting was changed to setting 1 in (b)(6) 2021, there were no improvement in symptoms.It was suspected a shunt dysfunction, therefore, the valve was removed and replaced (left side) on (b)(6) 2021.An intraoperative finding confirmed patency of ventricular and abdominal cavities.It was suspected that the valve was obstructed.

Manufacturer Narrative

The certas valve was returned for evaluation.Failure analysis: the position of the cam when valve was received was at setting 6.The valve was visually inspected; needle holes in the needle chamber were noted as well as scratch marks in the silicone housing.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 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 obstruction was noted.

Event Description

N/a.

• 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: 11572328
• MDR Text Key: 243861690
• Report Number: 3013886523-2021-00127
• 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: 05/18/2021

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: 828806
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2021
• Initial Date Manufacturer Received: 03/01/2021
• Initial Date FDA Received: 03/25/2021
• Supplement Dates Manufacturer Received: 05/02/2021
• Supplement Dates FDA Received: 05/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 80 YR