BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRTS SM IL SG VLV ONLY

    MDR report key: 12054504 · Received June 23, 2021

    Report

    Report Number
    3013886523-2021-00275
    Event Type
    Injury
    Date Received
    June 23, 2021
    Date of Event
    June 1, 2021
    Report Date
    September 16, 2021
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    JXG
    PMA / PMN Number
    NI
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS:  D4, D9, G3, G6, H2, H3, H4, H6, H10. THE CERTAS VALVE (828814) WAS RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR) - THE PRODUCT CODE 828814 WITH LOT 3830618 CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK. FAILURE ANALYSIS - THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS AT SETTING 7. THE VALVE WAS VISUALLY INSPECTED; NEEDLE HOLES IN NEEDLE CHAMBER WERE NOTED. THE VALVE WAS HYDRATED PER INTERNAL PROCESS. THE VALVE WAS LEAK TESTED AND ONLY LEAKED FROM THE NEEDLE HOLES. THE VALVE PASSED THE TEST FOR PROGRAMMING, OCCLUSION, REFLUX 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 ISSUE REPORTED BY THE CUSTOMER COULD HAVE BEEN DUE TO BIOLOGICAL DEBRIS AND PROTEIN BUILD UP INTERFERING WITH THE VALVE MECHANISM, AT THE TIME OF INVESTIGATION NO PRESSURE ISSUES WERE NOTED.

    Description of Event or Problem · 0

    N/A.

    Additional Manufacturer Narrative · 1

    ATTEMPTS ARE BEING MADE TO OBTAIN ADDITIONAL INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A FACILITY REPORTED THAT THE SHUNT PRESSURE WAS HIGH ON A CERTAS VALVE (828814) AFTER IMPLANT TO A PATIENT VIA V-P SHUNT ON (B)(6) 2019 WITH SETTING 4. THE SLIT-LIKE VENTRICLE CONTINUED, AND IT IMPROVED AS THE PRESSURE WAS GRADUALLY INCREASED, BUT IT BECAME A SLIT-LIKE VENTRICLE AGAIN, AND THE FINAL SET PRESSURE WAS SETTING 7. IT SEEMED THAT IT WAS PASSING THROUGH WHEN SHUNT CONTRAST WAS PERFORMED. WHEN THE PRESSURE WAS MEASURED, THE SHUNT PRESSURE WAS HIGH. THE PATIENT HAD AN OPEN PUPIL. THE VALVE WAS REMOVED AND REPLACED ON (B)(6) 2021. THE PATIENT'S PROGRESS IS CURRENTLY GOOD. NO FURTHER INFORMATION WAS PROVIDED BY THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    945753 CRTS SM IL SG VLV ONLY CERTAS PLUS SMALL & RA W/SG JXG INTEGRA LIFESCIENCES SWITZERLAND SAR 3830618

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR