BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTEGRA BOVINE PERICARDIUM DURAL GRAFT

    MDR report key: 5631977 · Received May 4, 2016

    Report

    Report Number
    3002719998-2016-00012
    Event Type
    Death
    Date Received
    May 4, 2016
    Report Date
    May 23, 2016
    Manufacturer
    RTI SURGICAL, INC
    Product Code
    GXQ
    PMA / PMN Number
    K081538
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE GRAFT WAS NOT RETURNED TO RTI FOR EVALUATION, THEREFORE A RE-REVIEW WAS PERFORMED OF THE MANUFACTURING RECORDS, STERILIZATION RUN REPORTS, ENVIRONMENTAL MONITORING RESULTS, QUALITY CONTROL / ASSURANCE REVIEWS AND RELEASE, AND THE COMPLAINT DATABASE FOR RELATED COMPLAINTS ASSOCIATED WITH THE LOT. RESULTS: NO DEVIATIONS WERE NOTED DURING PROCESSING FOR LOT NZ14180076. THE GRAFT UNDERWENT A VALIDATED STERILIZATION METHODOLOGY; TUTOPLAST® WHICH INCLUDES TERMINAL STERILIZATION BY GAMMA IRRADIATION AFTER PACKAGING. ENVIRONMENTAL DATA AND RECORDS GENERATED DURING AND AROUND THE TIME OF PROCESSING FOR THE LOT WERE ACCEPTABLE. TO DATE, RTI HAS DISTRIBUTED (B)(4) XENOGRAFTS FROM THIS LOT WITHOUT RELATED COMPLAINTS. CONCLUSION: THE DEVICE WAS NOT AVAILABLE FOR EVALUATION. RECORDS RE-REVIEW RESULTS DEMONSTRATED NO DEVIATIONS DURING THE MANUFACTURING OF GRAFT (B)(4) AND THE GRAFT MET ALL SPECIFICATION REQUIREMENTS AND RELEASE CRITERIA AT THE TIME OF DISTRIBUTION. NO RELATED COMPLAINTS WERE NOTED ASSOCIATED WITH THIS LOT. OTHER DEVICES WERE UTILIZED IN THE SURGERY WHICH MAY HAVE CONTRIBUTED TO THE REPORTED COMPLICATIONS. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE INFECTION WAS A CONSEQUENCE OF THE PATIENT'S IMMUNOCOMPROMISED STATUS. BASED ON OUR RECORDS RE-REVIEW, THIS EVENT IS UNLIKELY RELATED TO THE XENOGRAFT IMPLANT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED DOES NOT ALTER THE FORMER CONCLUSIONS.

    Description of Event or Problem · 1

    RTI SURGICAL, INC (RTI) RECEIVED A COMPLAINT ON (B)(6) 2016 INDICATING THAT A PATIENT DEVELOPED A SUBDURAL EMPYEMA AFTER IMPLANTATION OF THE BOVINE PERICARDIUM DURAL GRAFT. THE SURGEON IS A FIRST TIME USER AND HAS CONCERNS REGARDING INFECTION. IT WAS ALSO REPORTED THAT THE FOLLOWING CONCOMITANT DEVICE WAS UTILIZED DURING THE SURGERY: DP1033 DURAGEN PLUS DURAL REGENERATION MATRIX 3X3, LOT# 1150313 (NOT MANUFACTURED BY RTI). ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL FROM THE DISTRIBUTOR ((B)(4)) INDICATING THAT PER CONVERSATION WITH THE USER FACILITY RISK MANAGEMENT, THE FACILITY CONDUCTED QUALITY ASSURANCE REVIEW OF THE INCIDENT. THE SURGEON STATED THAT THE PATIENT WAS IMMUNOCOMPROMISED PRIOR TO THE SURGERY. IT WAS FELT THAT THE CAUSE OF THE INFECTION WAS DUE TO THE PATIENT'S CONDITION AND NOT THE IMPLANTED DEVICES.

    Description of Event or Problem · 1

    ON 5/23/2016, A CONFERENCE CALL WAS HELD WITH INTEGRA LIFE SCIENCES COMPLAINT DEPARTMENT REGARDING INFORMATION THAT WAS NOT DISCLOSED TO THEM AT THE TIME THIS COMPLAINT WAS REPORTED. THE PATIENT DIED IN (B)(6) 2016 (UNKNOWN DATE). THE HOSPITAL CONTACTED INTEGRA TO REQUEST ADDITIONAL INFORMATION REGARDING COMPLAINTS RELATED TO THE COMPLAINT BOVINE PERICARDIUM LOT, AT WHICH TIME IT WAS REPORTED THAT THE PATIENT HAD DIED. THE CAUSE OF DEATH IS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE PATIENT HAD OTHER UNDERLYING ISSUES (NOT DISCLOSED) AND WAS ON STEROIDS AND OTHER MEDICATIONS THAT COULD HAVE COMPROMISED HIS IMMUNE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286152 INTEGRA BOVINE PERICARDIUM DURAL GRAFT BOVINE PERICARDIUM DURAL GRAFT GXQ RTI SURGICAL, INC NZ14180076

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| O