BEUDAMED
    FDA Adverse Event Death Summary report: N

    CERTAS INLIN VLV SPHN/UNIT CAT

    MDR report key: 10280379 · Received July 15, 2020

    Report

    Report Number
    1226348-2020-00240
    Event Type
    Death
    Date Received
    July 15, 2020
    Date of Event
    April 27, 2020
    Report Date
    April 28, 2020
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    JXG
    PMA / PMN Number
    K143111
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UNIQUE DEVICE IDENTIFICATION (UDI): (B)(4). THE CERTAS VALVE WAS RECEIVED FOR EVALUATION. DEVICE HISTORY RECORD (DHR) LOT: 3429169, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK. FAILURE ANALYSIS - THE VALVE WAS VISUALLY INSPECTED, BIOLOGICAL DEBRIS INSIDE THE VALVE. THE VALVE FAILED THE TEST FOR PROGRAMMING AND FLUSH. THE VALVE COULD NOT BE TESTED FOR LEAK, REFLUX AND PRESSURE DUE TO OCCLUSION. BIOLOGICAL DEBRIS WAS NOTED ON THE ROTATING CONSTRUCT, ON THE HELICAL SPRING, ON THE CAM/BALL ARM ASSEMBLY, ON THE RUBY BALL, AND ON THE SEAT OF RUBY BALL. THE ROOT CAUSE FOR THE PROBLEMS NOTED DURING INVESTIGATION ARE DUE TO BIOLOGICAL FOUND ON THE ROTATING CONSTRUCT, AND ON THE HELICAL SPRING ON THE CAM/BALL ARM ASSEMBLY, ON THE RUBY BALL, AND ON THE SEAT OF RUBY BALL. THE ROOT CAUSE FOR THE OVER DRAINAGE ISSUE REPORTED BY THE CUSTOMER COULD HAVE BEEN DUE TO BIOLOGICAL DEBRIS INTERFERING WITH THE VALVE MECHANISM, AT THE TIME OF INVESTIGATION OVER DRAINAGE COULD NOT BE CONFIRMED.

    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. BETWEEN 05NOV 2019 AND 30JUN 2020, APPROXIMATELY 2,200 MDRS SUBMITTED ELECTRONICALLY BY INTEGRA LIFESCIENCES VIA TRACKWISE, INTEGRA'S COMPLAINT HANDLING SYSTEM, WERE NOT RECEIVED BY CDRH DUE TO A COMPUTER SYSTEM ISSUE. WITHIN THIS TIME PERIOD, AN ERROR WITH INTEGRA'S MIDDLEWARE, WHICH FACILITATES COMMUNICATIONS BETWEEN TRACKWISE AND THE FDA SYSTEM, CAUSED THE COMPLAINT RECORDS TO CLOSE AND INDICATE WE HAD RECEIVED AN ACKNOWLEDGEMENT 3 FROM THE FDA WHEN WE HAD NOT. INTEGRA INTERPRETED THE ACKNOWLEDGEMENT AS A SUCCESSFUL SUBMISSION; HOWEVER, SUBSEQUENT INVESTIGATION REVEALED THE ACKNOWLEDGEMENT 3 RECEIVED WAS FROM OUR MIDDLEWARE AND NOT FROM THE FDA (THESE ACKNOWLEDGEMENTS HAVE BEEN RETAINED AS PART OF THE DOCUMENTATION OF THE MDR). THE MALFUNCTION WAS RELATED TO THE RELOCATION OF THE TRACKWISE APPLICATION TO A NEW DATA CENTER DURING THE TRANSITION OF INTEGRA'S CORPORATE HEADQUARTERS FROM (B)(4). PREVIOUSLY, INTEGRA HAD BEEN SUCCESSFULLY RECEIVING ACKNOWLEDGEMENTS 1, 2, AND 3 FROM THE FDA, AND OUR RECORDS REFLECT THESE ACKNOWLEDGEMENTS, INCLUDING THE DATE AND TIME STAMPS. (B)(4) AND (B)(4) HAVE BEEN OPENED BY INTEGRA TO FURTHER INVESTIGATE THE NONCONFORMANCE AND DEVELOP A CORRECTIVE ACTION PLAN. THE MIDDLEWARE ERROR HAS BEEN CORRECTED, AND INTEGRA HAS FILED MDRS SINCE THE CORRECTION AND VERIFIED THAT THE APPROPRIATE ACKNOWLEDGEMENTS HAVE BEEN RECEIVED FROM THE FDA. INTEGRA IS RESUBMITTING ALL IMPACTED MDR REPORTS FOR THE TIME PERIOD 05NOV2019 THROUGH 30JUN2020. INTEGRA LIFESCIENCES CONTACTED (B)(4), DIRECTOR OF REGULATORY PROGRAMS, OFFICE OF PRODUCT EVALUATION AND QUALITY AND (B)(4), ASSISTANT DIRECTOR, MDR TEAM, OFFICE OF PRODUCT EVALUATION AND QUALITY ON JULY 8-9, 2020 TO REPORT THESE ISSUES REGARDING MDR REPORTS.

    Description of Event or Problem · 1

    A PHYSICIAN REPORTED OVER DRAINAGE OF A CERTAS VALVE. "THE VALVE WAS IMPLANTED VIA V-P SHUNT. IMPLANT DATE AND INITIAL SETTING WERE UNKNOWN. AFTER IMPLANTED, THE PATIENT PRESENTED WITH OVER DRAINAGE SYMPTOMS. THE SETTING WAS INCREASED TO 7, BUT IT DID NOT IMPROVE THE PATIENT¿S SYMPTOMS. IT WAS UNKNOWN IF THE VIRTUAL-OFF WAS PERFORMED OR NOT. THE PATIENT WAS DECEASED DUE TO CEREBRAL HEMORRHAGE. THE PHYSICIAN DOES NOT SUSPECT THE CAUSAL RELATIONSHIP BETWEEN THE CAUSE OF DEATH AND THE VALVE FUNCTION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743751 CERTAS INLIN VLV SPHN/UNIT CAT CERTAS PLUS W/ SG JXG INTEGRA LIFESCIENCES SWITZERLAND SAR 3429169

    Patients

    Seq Age Sex Outcome Treatment
    1