MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CERTAS INLIN VLV ONLY W/SPHNGD; CERTAS PLUS W/ SG

Model Number	82-8804PL
Medical Device Problem Code	Device Difficult to Program or Calibrate (1496)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
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.
Event or Problem Description
A physician reported a certas plus valve was implanted on (b)(6) 2020, and the position has never been adjusted.Immediately postoperatively there was blood in the ventricles, but the drain certainly did his work.The neurosurgeon would like to make it go faster now, but he isn¿t able to change the position.He tried the analogy tool and the digital system and magnets directly on the skin and nothing worked.The last option was an mri yesterday with the hope the magnet could pull something off but didn¿t work.Product manager and sales rep had a meeting with the surgeon and what they understood it is not a normal hydrocephalus person.The patient has neurofibromatosis in the eye and is stable now.Product manager asks all the steps which needs to be done before taking the step to change the valve and the conclusion is they did everything to adjust a new setting, but it didn¿t work.Comments from surgeon: "the biggest problem is that he has the shunt to decrease an arachnoid cyst behind the orbit.This arachnoid cyst pushes his eyeball outwards.After placement of the shunt this decreased, now it has increased again, this is the reason why i want to decrease the resistance setting of the certas valve." comments from integra marketing: "following our conversation and looking at the valve x-ray you sent us, i believe you have done all the due diligence i am aware of that is required to troubleshooting and reprogram the valve.Unfortunately, at this point, i don¿t believe there is much more we can suggest to reprogram this valve.".
Additional Manufacturer Narrative
Additional information received: "device still in the patient but device will be explanted.They have no the date of the surgery for the moment.".
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h6, h10.The certas valve was returned for evaluation: failure analysis - the valve was visually inspected; no defect was noted.The valve passed the tests for programming, occlusion, leaks, reflux, siphon guard and pressure.No root cause could be determined as the technician could not confirm any problem with the valve at the time of investigation.The possible root cause for the problem reported by the customer could be due to biological debris and protein build up interfering with the valve mechanism, at the time of investigation no functional issues were noted.

• Brand Name: CERTAS INLIN VLV ONLY W/SPHNGD
• Common Device Name: CERTAS PLUS 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 ; 6099362319
• MDR Report Key: 13195178
• Report Number: 3013886523-2022-00003
• Device Sequence Number: 4258301
• Product Code: JXG
• UDI-Device Identifier: 10886704079040
• UDI-Public: 10886704079040
• Combination Product (Y/N): N
• PMA/510(K) Number: K143111
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/12/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 82-8804PL
• Device Catalogue Number: 828804
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/17/2021
• Supplement Date Received by Manufacturer: 02/02/2022; 03/28/2022
• Initial Report FDA Received Date: 01/07/2022
• Supplement Report FDA Received Date: 02/16/2022; 04/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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