MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CRTS SM IL VLV ONLY; CERTAS PLUS SMALL & RA

Model Number	828810PL
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/11/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A physician reported a certas valve (id 828810pl ) failed in a pediatric patient due to yellowish build up on distal end of valve.The valve was acceptable upon initial implantation.
Additional 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 or Problem Description
N/a.
Additional Manufacturer Narrative
The certas valve (id (b)(4)) was not returned for evaluation after three good faith attempts (gfes) were made.Lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.The root cause(s) of the reported issue could not be determined.However, the possible root cause for the issue reported by the customer, could be due to biological debris and protein build up interfering with the valve mechanism.Since no valve was returned for investigation this could not be confirmed.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.Additional information received - was the issue detected during or after implantation? answer: after.- current status of the patient.Answer: doing well, but has had two subsequent vp shunt revisions on (b)(6) 2023.- did the patient have any sigs and symptoms due to the product problem? answer: yes, shunt malfunction radiographically, but not symptomatically.- was the valve replaced? answer: a new fixed medium pressure valve was placed on (b)(6) 2022 at the time of explant of the certas valve.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The certas valve (id 828810pl) was returned for evaluation.Device history record - the product code 82-8810pl with lot 6105683, conformed to the specifications when released to stock.Failure analysis - the position of the cam when valve was received was at setting 4.The valve was visually inspected; biological debris around the cam was noted.The valve was hydrated.The valve was tested for programming and pressure then failed the test.The valve passed the test for occlusion, leaks and reflux.The valve was disassembled.The valve was visually inspected under microscope at appropriate magnification: biological debris was found on the motor.The root cause for the issue reported by the customer is due to biological debris and protein build up interfering with the valve mechanism.As during the investigation, the biological debris were found.

• Brand Name: CRTS SM IL VLV ONLY
• Common Device Name: CERTAS PLUS SMALL & RA
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• Manufacturer (Section G): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; ch-2400; le locle ; SZ
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 15981306
• Report Number: 3013886523-2022-00575
• Device Sequence Number: 17892026
• Product Code: JXG
• UDI-Device Identifier: 10381780529316
• UDI-Public: (01)10381780529316(17)261231(10)6105683
• Combination Product (Y/N): N
• PMA/510(K) Number: NI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/12/2023

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
• Operator of Device: Health Professional
• Device Model Number: 828810PL
• Device Catalogue Number: 828810PL
• Device Lot Number: 6105683
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/22/2022
• Supplement Date Received by Manufacturer: 03/16/2023; 06/20/2023
• Initial Report FDA Received Date: 12/14/2022
• Supplement Report FDA Received Date: 03/29/2023; 07/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/26/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown