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

Catalog Number	828814PL
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Codes	Abdominal Pain (1685); Vomiting (2144); Sleep Dysfunction (2517)
Date of Event	06/06/2024
Type of Reportable Event	Serious Injury
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
A facility reported no flow of a certas valve (id 828814pl) that was implanted on (b)(6) 2024.On (b)(6) 2024, the valve was adjusted from 4 to 2 due to imaging findings (interval dilation of the right ventricle) and the patient tolerated the adjustment with improved symptoms overnight.On (b)(6) 2024, the patient experienced vomiting, increased irritability, appetite change, crying, abdominal pain, and increased sleeping.Imaging repeated showing increase in ventricle.At this time, the valve was re-programmed from 2 to 1.On (b)(6) 2024, the patient showed no improvement of symptoms and the imaging showed no change to ventricular caliber despite the reprogramming that occurred the previous day from 2 to 1.Therefore, the patient was taken to the operating room for revision, and the valve was explanted and replaced on (b)(6) 2024.There is no other device or therapy being used on the patient at the time of the event that may have caused or contributed to the event.It is also unknown if the patient had any of the pre-existing characteristics that may have contributed to the event.Patient returned to its neurologic baseline.
Additional Manufacturer Narrative
The certas valve (id 828814pl) was returned for evaluation.Device history record (dhr)- the product code 82-8814pl with lot 7354881, conformed to the specifications when released to stock.Failure analysis - the position of the cam when valve was received was at setting 1.The valve was visually inspected; no defect was noted.The valve was hydrated.The valve passed the test for occlusion, leak, reflux and siphon guard.The siphon guard was removed.The valve failed the test for programming and pressure.The valve was disassembled.The valve was visually inspected under microscope at appropriate magnification: biological debris was found on the spring, on the rotating construct, on the ruby ball, on the seat of the ruby ball and on the arm assembly.Root cause analysis - at the time of investigation, no flush issue was noted.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.The root cause for the pressure issue noted during the investigation is due to biological debris found on the ruby ball and on the cam / ball arm assembly as well as the rc, the debris was stopping the ruby ball from being seated correctly.
Event or Problem Description
N/a.

• Brand Name: CRTS SM IL SG VLV ONLY
• Common Device Name: CERTAS PLUS SMALL & RA W/SG
• 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 08540 ; 6099362319
• MDR Report Key: 20004193
• Report Number: 3013886523-2024-00245
• Device Sequence Number: 4915298
• Product Code: JXG
• UDI-Device Identifier: 10381780529378
• UDI-Public: (01)10381780529378(17)281231(10)7354881
• Combination Product (Y/N): N
• PMA/510(K) Number: K182265
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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
• Report Date (Section B): 09/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 828814PL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2024
• Supplement Date Received by Manufacturer: 09/04/2024
• Initial Report FDA Received Date: 08/20/2024
• Supplement Report FDA Received Date: 09/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 3 YR
• Patient Sex: Male
• Patient Race: White