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

Model Number	828810PL
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/23/2022
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
This is 5 of 5 reports linked to mfg report numbers: 3013886523-2022-00471, 3013886523-2022-00472, 3013886523-2022-00473, 3013886523-2022-00474.A physician reported an unknown certas valve was implanted in a 20 month-old female patient on (b)(6) 2022.The valve was found at an incorrect setting after mri using both hand held and manual devices on multiple dates ((b)(6) 2022, (b)(6) 2022, (b)(6) 2022, (b)(6) 2022, (b)(6) 2022).Therefore, the valve was removed.Note: although only one valve was removed, five reports have been opened for this event because it is unknown if the valve remained with the wrong setting during 10 days, or if the setting was corrected/adjusted each time it was found incorrect (5 occasions).A request for clarification was sent; however, no additional information has been received.Our reasoning is that the valve changed the setting in 5 occasions.
Additional Manufacturer Narrative
The certas valve (id 828810pl) was returned for evaluation.Device history record (dhr) - the product code 82-8810pl with lot 6247702 conformed to the specifications when released to stock.Failure analysis - the position of the cam when valve was received was at setting 5.The valve was visually inspected, needle holes in the needle chamber were noted as well as liquid and biological debris in the valve casing.The valve was leak tested and only leaked from the needle hole in the needle chamber.The valve passed the test for programming, occlusion, reflux and pressure.The valve was dismantled and was examined under microscope at appropriate magnification: biological debris was noted on the ruby ball and on the cam / ball arm assembly as well as the "rc".The root cause for the pressure issue noted during the investigation is due to biological debris found on the ruby ball and on the cam / ball arm assembly as well as the rc, the debris was stopping the ruby ball from being seated correctly.The possible root cause for the programing issue reported by the customer could be due to ¿valve no longer mri resistant, can unintentionally change setting.¿.
Event or Problem Description
N/a.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: d1, d2a, d4, d6b, g3, g6, h2, h3.Additional information received; certas valve 82-8810pl implanted (b)(6) 2022.Removed on (b)(6) 2022 lot # 6247702 confirmation received: question: from date (b)(6) 2022 to (b)(6) 2022, the valve setting was incorrect for ten days, or the setting was corrected and then the valve changed the setting in 5 occasions (b)(6) 2022 answer - "the valve setting was noted to be incorrect on each of those 5 dates for at most a couple of hours after mri, and then was reprogrammed." "meaning, on 9/13, we got an mri scan, checked the setting, fixed the setting, and all was well until the next mri.With a repeat mri the same day, we saw the same issue, and fixed it promptly.With another scan on 9/14, same sequence, etc.".

• Brand Name: CRTS SM IL VLV ONLY
• Common Device Name: CERTAS PLUS SMALL & RA
• 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: 15650321
• Report Number: 3013886523-2022-00475
• Device Sequence Number: 14944021
• Product Code: JXG
• UDI-Device Identifier: 10381780529316
• UDI-Public: (01)10381780529316(17)270228(10)6247702
• Combination Product (Y/N): N
• PMA/510(K) Number: NI
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/07/2022

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: 828810PL
• Device Catalogue Number: 828810PL
• Device Lot Number: 6247702
• 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: 09/26/2022
• Supplement Date Received by Manufacturer: 10/19/2022; 11/21/2022
• Initial Report FDA Received Date: 10/21/2022
• Supplement Report FDA Received Date: 11/09/2022; 12/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/22/2022
• 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 Age: 20 MO
• Patient Sex: Female