MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CERTAS PLUS INLINE VALVE ONLY

Catalog Number	828800PL
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Coma (2417)
Date of Event	05/30/2023
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 a certas valve (id 828800pl) was implanted in (b)(6) 2023, complicated by a hygroma and then a subdural hematoma.The valve changed settings without intervention.The shunt was turned to 8, and when ventricles blew up, the hematoma was evacuated.Before discharge, the patient had ct scan that showed very small ventricles.X-ray of the valve looked like 8 but a little off.It was adjusted again to 8, however, they think they didn't do anything.The patient was discharged and was back the next day with large ventricles again.On (b)(6) 2023, medical staff change the valve to 7/8 and confirmed on xray.The patient has had a difficult course; therefore, it was taking it down to 6/8, however, on (b)(6) 2023 x-ray showed the valve was at 8/8.It was adjusted down to 6/8, however, x-ray later that day showed it is at 5/8.The valve was removed and replaced with certas plus siphonguard on (b)(6) 2023.According to information provided: medical staff believe the valve was acceptable when initially implanted, but failed after 6 weeks of being implanted.It is potentially hard to determine if the valve malfunctioned as there are many factors such as human error with programming.The patient went into comatose state, but not sure if is because of the valve or user error.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h6, h10 certas valve (id 828800pl) was not returned for evaluation and lot number information has not been provided; therefore, an evaluation of the device could not be performed, and device history record (dhr) could not be reviewed.The root cause(s) of the reported issue could not be determined.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.

• Brand Name: CERTAS PLUS INLINE VALVE ONLY
• Common Device Name: CERTAS PLUS
• 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: 17171865
• Report Number: 3013886523-2023-00187
• Device Sequence Number: 20621600
• Product Code: JXG
• UDI-Device Identifier: 10381780521013
• UDI-Public: 10381780521013
• Combination Product (Y/N): N
• PMA/510(K) Number: K143111
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• 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): 09/14/2023

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 Catalogue Number: 828800PL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/30/2023
• Supplement Date Received by Manufacturer: 09/05/2023
• Initial Report FDA Received Date: 06/21/2023
• Supplement Report FDA Received Date: 09/14/2023
• 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