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

Model Number	82-8814PL
Medical Device Problem Codes	Break (1069); Pressure Problem (3012)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/06/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility reported an unintended setting change of a certas valve (id 828814pl) from 1 to 5.The patient presented to the clinic for routine follow up with mri prior to the appointment, and his scan showed dramatically increased subdural fluid collections l > r.The valve was implanted on (b)(6) 2020 to treat subdural fluid collections requiring right subdural-peritoneal shunt placement.The patient was exposed to 2 mris: on (b)(6) 2022 (1.5t aera mri machine ) and (b)(6) 2023 (1.5t sola mri machine).The last x-ray for valve setting confirmation was on january 27, 2022 at an outside hospital.We did not check valve setting after (b)(6) 2022 mri or after (b)(6) 2023 mri because it¿s a certas plus.According to information provided, it is unknown if the patient was exposed to a significant acceleration or deceleration such as a car accident or fall.During explantation of the valve on (b)(6) 2023, the siphonguard broke off of the distal end of valve.
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
N/a.
Additional Manufacturer Narrative
Certas valve (id 828814pl) has been returned for evaluation: device history record (dhr) - product code 82-8814pl with lot 4837636, conformed to the specifications when released.Failure analysis - the position of the cam when valve was received was at setting 5.The valve was visually inspected, a bump mark was noted in the upper casing and the rotation construct in the up position the silicone housing is cut/torn around the siphon guard.The valve was hydrated.The valve was leak tested and leaked from the damaged silicone housing.The valve was tested for programming and failed.The valve could not be reflux due to damaged silicone housing.The siphon guard was visually inspected mark were noted on the siphon guard.The valve passed the test occlusions and pressure.The valve casing was dismantled and was examined under microscope at appropriate magnification: when dismantled stress marks were noted in the bump mark in the upper casing.The root cause for the bump and stress marks in the top of the valve casing noted during the investigation is due to the valve receiving a knock.The root cause for the rotating construct stuck in the upper position noted during the investigation is due to the valve receiving a knock.The root cause for the ¿unintended setting change¿ issue reported by the customer could be due to ¿rc tooth drops and stays on top of lc divider post after adjustment due to interference from 360 stop.¿ and potential effects of failure include ¿'pressure setting susceptible to unintended changes due to external forces (i.E., magnetic or impact force)¿, no unintended changes to the setting of the valve were noted at investigation, as the valve would not program.The root cause for the cut/tear in the silicone housing is probably due to a sharp or pointed object, or handling, as noted in the ifu silicone has a low cut/tear resistance.The root cause for the marks in the siphon guard is due to a sharp or pointed object coming into contact with the siphon guard.

• Brand Name: CRTS SM IL SG VLV ONLY
• Common Device Name: CERTAS PLUS SMALL & RA 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: 16419214
• Report Number: 3013886523-2023-00058
• Device Sequence Number: 3289486
• Product Code: JXG
• UDI-Device Identifier: 10886704081937
• UDI-Public: (01)10886704081937(17)250731(10)4837636
• Combination Product (Y/N): N
• PMA/510(K) Number: K182265
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2023

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 Expiration Date: 07/31/2025
• Device Model Number: 82-8814PL
• Device Catalogue Number: 828814PL
• Device Lot Number: 4837636
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/07/2023
• Supplement Date Received by Manufacturer: 04/12/2023
• Initial Report FDA Received Date: 02/22/2023
• Supplement Report FDA Received Date: 04/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2020
• 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