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

Catalog Number	828810PL
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Codes	Cerebral Ventriculomegaly (2133); Irritability (2421); Ambulation or Postural Difficulties (2544)
Date of Event	07/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Medwatch #: (b)(4).A facility reported a certas valve (id 828810pl) was implanted on (b)(6) 2021 with setting at 3.In (b)(6) 2023, the valve was reprogrammed from 3 to 5 due to a progressive decrease in ventricle size.The patient did well with no recurrent seizures.On (b)(6) 2024, during a clinic visit, it was found that the valve could no longer be adjusted from its setting of 3 and the magnetic resonance imaging (mri) showed dilatation of the left lateral ventricle, which was higher than what was seen on imaging in (b)(6) 2023.The ventricle size in (b)(6) 2024 was larger than her previous ventricles size when her previous intentional setting was at 3 in (b)(6) of 2023.Between (b)(6) 2024 and (b)(6) 2024, the patient had worsening of ability to perform motor skills (stopped walking in (b)(6) 2024), rubbing ears and rubbing head (non-verbal patient), waking from sleep crying, inability to sleep in recumbent, increased daytime irritability, and progressive ventricular dilation due to abnormal intracranial pressure.The valve was removed and replaced.The patient symptoms improved, is now walking again and no longer rubbing ears or head.
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.
Additional Manufacturer Narrative
Certas valve (id 828810pl) was returned for evaluation.Device history record (dhr) - the product code 828810pl with lot 4403265, 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, no defect was noted.The valve was hydrated.The valve passed the test for occlusion, leak and reflux.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 - 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, at the time of investigation biological debris were found.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.

• 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 08540 ; 6099362319
• MDR Report Key: 20004135
• Report Number: 3013886523-2024-00244
• Device Sequence Number: 20062388
• Product Code: JXG
• UDI-Device Identifier: 10886704081890
• UDI-Public: (01)10886704081890(17)241231(10)4403265
• Combination Product (Y/N): N
• PMA/510(K) Number: K182265
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• 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 Expiration Date: 12/31/2024
• Device Catalogue Number: 828810PL
• Device Lot Number: 4403265
• 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: 07/24/2024
• Supplement Date Received by Manufacturer: 08/30/2024
• 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: 01/31/2020
• 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: 5 YR
• Patient Sex: Female
• Patient Race: White