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

Model Number	82-8800PL
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Codes	Headache (1880); Hydrocephalus (3272); Cerebral Edema (4403)
Type of Reportable Event	Death
Event or Problem Description
A facility reported a valve (unknown manufacturer) has been implanted for (b)(6) and never revised.The patient is a (b)(6) female since birth presented with proximal vp shunt obstruction.The patient presented with hydrocephalus and headaches for 72 months and on (b)(6) 2022, a certas plus valve (id (b)(6)) was implanted with setting 5.At the time of the valve implantation, the patient had a headache, but she was neurologically intact and there were no issues during valve insertion.The patient was monitored in icu for 24 hours and on (b)(6) 2022, the shunt settings changed from 5 to 3 and the patient coded (tachycardic and was found unresponsive in bed).The patient suffered cardiac arrest at approximately 9:00p.M.On (b)(6) 2022, a revision surgery was attempted unsuccessfully due to collapsed ventricles due to massive brain edema.The patient passed away on (b)(6) 2022.
Additional Manufacturer Narrative
The device involved in the reported incident is not available for evaluation.An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.(b)(4).
Event or Problem Description
A facility reported a valve (unknown manufacturer) has been implanted for 40 years and never revised.The patient is a (b)(6) female since birth presented with proximal vp shunt obstruction.The patient presented with hydrocephalus and headaches for 72 months and on (b)(6) 2022, a certas plus valve (id (b)(6)) was implanted with setting 5.At the time of the valve implantation, the patient had a headache, but she was neurologically intact and there were no issues during valve insertion.The patient was monitored in icu for 24 hours and on (b)(6) 2022, the shunt settings changed from 5 to 3 and the patient coded (tachycardic and was found unresponsive in bed).The patient suffered cardiac arrest at approximately 9:00p.M.On (b)(6) 2022, a revision surgery was attempted unsuccessfully due to collapsed ventricles due to massive brain edema.The patient passed away on (b)(6) 2022.
Additional Manufacturer Narrative
The device involved in the reported incident is not available for evaluation.An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.(b)(4).
Additional Manufacturer Narrative
Additional information received: there was no radiographic confirmation of the initial and any other setting changes; the value was programmed each time the value was interrogated to confirm the programming.Following warning glasgow coma scale (gcs) of 3, the patient went for shunt revision, but ventricles were collapsed and placing a new ventricular catheter was impossible.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The certas valve (id (b)(6)) 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 of the reported issue could not be determined.However, a probable root cause for the reported complaint is due to biological debris and protein build up interfering with the valve mechanism.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.
Event or Problem Description
N/a.

• 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: 13506957
• Report Number: 3013886523-2022-00044
• Device Sequence Number: 5148396
• Product Code: JXG
• UDI-Device Identifier: 10886704079002
• UDI-Public: (01)10886704079002(17)250331(10)4469605
• Combination Product (Y/N): N
• PMA/510(K) Number: K143111
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/05/2022

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 Expiration Date: 03/31/2025
• Device Model Number: 82-8800PL
• Device Catalogue Number: 828800PL
• Device Lot Number: 4469605
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/26/2022
• Supplement Date Received by Manufacturer: 02/28/2022; 11/18/2022
• Initial Report FDA Received Date: 02/10/2022
• Supplement Report FDA Received Date: 03/15/2022; 12/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2020
• 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
• Patient Sex: Unknown