MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CERTAS PLUS INLINE WITH SIPHON; CERTAS PLUS W/ SG

Model Number	82-8804PL
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Cerebral Ventriculomegaly (2133)
Date of Event	05/16/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
1 of 2 reports linked to mfg report number: 3013886523-2022-00237.A physician reported a certas valve (id 828804pl) was implanted due to snph (secondary normal pressure hydrocephalus) via v-p shunt on (b)(6) 2022 with unknown setting.It was used with bactiseal catheter (id 823072).On (b)(6) 2022, the patient developed disorientation and underwent an x-ray examination, and ventricular enlargement was confirmed.Due to a suspicion of shunt failure the valve and catheter were removed and replaced on (b)(6) 2022.
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
The certas valve was returned for evaluation.Failure analysis - the position of the cam when valve was received was at setting 1.The valve was visually inspected; a lot of biological debris was found in the valve casing and the siphon guard.The valve was hydrated.The valve was tested for programming; the valve passed the test for setting but the cam position could not be confirmed due to the biological debris.The valve was flushed and failed, valve occlusion confirmed.The valve could not be leak and reflux tested due to the occlusion.The siphon guard was removed and tested.The siphon guard failed the test due to the biological debris.Complaint valve failure confirmed.The root cause for the ¿shunt failure was suspected¿ issue reported by the customer is due to biological debris and protein build up interfering with the valve mechanism.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.

• Brand Name: CERTAS PLUS INLINE WITH SIPHON
• 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: 14567458
• Report Number: 3013886523-2022-00236
• Device Sequence Number: 5095579
• 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: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2022

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 Model Number: 82-8804PL
• Device Catalogue Number: 828804PL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/17/2022
• Supplement Date Received by Manufacturer: 06/28/2022
• Initial Report FDA Received Date: 06/01/2022
• Supplement Report FDA Received Date: 07/13/2022
• 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: Male