BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONX AORTIC STANDARD 23

    MDR report key: 8174695 · Received December 18, 2018

    Report

    Report Number
    1649833-2018-00176
    Event Type
    Injury
    Date Received
    December 18, 2018
    Date of Event
    November 23, 2018
    Report Date
    January 31, 2019
    Manufacturer
    ON-X LIFE TECHNOLOGIES, INC.
    Product Code
    LWQ
    PMA / PMN Number
    P000037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW WAS MADE OF THE AVAILABLE INFORMATION. PRODUCT WAS IMPLANTED (B)(6) 2018 IN THE AORTIC POSITION OF A 70 YEAR OLD MALE REGISTERED IN A POST APPROVAL STUDY. THE PATIENT EXPERIENCED A BLEEDING EVENT LEADING TO "ANEMIA NYD" (NOT YET DIAGNOSED) FOR WHICH HE RECEIVED 2 UNITS OF PACKED RED BLOOD CELLS (PRBC'S) AT AN EMERGENCY DEPARTMENT AND WAS SENT HOME. THE EVENT IS CONSIDERED FULLY RESOLVED. IT SHOULD BE NOTED THAT THIS PATIENT IS IN THE CURRENT POST APPROVAL STUDY. ALL SUCH PATIENTS SHOULD BE ON THE RECOMMENDED INR THERAPY OF 1.5-2.0 PLUS A DAILY LOW DOSE ASPIRIN. WITH AN INR REPORTED AT 3.1 UPON ADMISSION, THE PATIENT WAS SIGNIFICANTLY HIGHER THAN THE RECOMMENDATION, AND EXCEEDS EVEN THE HIGH END OF THE STANDARD, INR 2.0-3.0. DESPITE THIS THERE IS NO EVIDENCE PRESENTED TO IDENTIFY A CAUSE OF THE BLEED. THE INSTRUCTIONS FOR USE (IFU) FOR THE PRODUCT LISTS BLEEDING AS A POSSIBLE COMPLICATION OF MECHANICAL HEART VALVE REPLACEMENT. HISTORICALLY, THE CATEGORY OF "MAJOR HEMORRHAGE" OCCURS AT A RATE OF 1.5% PATIENT-YEAR FOR RIGID HEART VALVES. IN THE PROACT STUDY, IN A DIRECT COMPARISON, VALVE REPLACEMENT HIGH RISK CONTROL GROUPS (INR 1.5-2.0) MAJOR BLEEDING RATE OF 1.59% PATIENT-YEAR RATE COMPARED TO THE CONTROL GROUP (INR 2.0-3.0) MAJOR BLEEDING RATE OF 3.94% PATIENT-YEAR. OVER ANTICOAGULATION LIKELY WORSENED THE BLEEDING EVENT BUT THERE IS NO IDENTIFIED CAUSE FOR IT. THEREFORE, NO EVIDENCE THAT THE VALVE CONTRIBUTED TO THE CAUSE OF THE BLEED, THOUGH THE REQUIREMENT FOR ANTICOAGULATION MAY HAVE IMPACTED ITS MAGNITUDE. THE RISK MANAGEMENT FILE THOROUGHLY IDENTIFIES THE PROCESS AND PRODUCT HAZARDS FOR APPROVED INDICATIONS. EACH INDIVIDUAL HAZARD IS MITIGATED AND REDUCED AS LOW AS POSSIBLE BY DESIGN AND PROCESS. POST PRODUCTION RESIDUAL RISK IS COMMUNICATED IN THE PRODUCT'S LABELING AND IFU. NO ACTION NECESSARY. THIS EVENT DOES NOT IDENTIFY ADDITIONAL HAZARDS OR MODIFY THE PROBABILITY AND SEVERITY OF EXISTING HAZARDS. THIS REPORT IS BEING SUBMITTED AS REQUIRED BY FEDERAL REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. FURTHERMORE, THIS REPORT REFLECTS THE EVENT AS ALLEGED BY THE COMPLAINANT AND DOES NOT IMPLY THAT THE INFORMATION REPORTED TO CRYOLIFE IS ACCURATE OR HAS BEEN CONFIRMED BY CRYOLIFE.

    Additional Manufacturer Narrative · 0

    A REVIEW WAS MADE OF THE AVAILABLE INFORMATION. PRODUCT WAS IMPLANTED (B)(6) 2018, IN THE AORTIC POSITION OF A 70 YEAR OLD MALE REGISTERED IN A POST APPROVAL STUDY. THE PATIENT EXPERIENCED A BLEEDING EVENT LEADING TO "ANEMIA NYD" (NOT YET DIAGNOSED) FOR WHICH HE RECEIVED 2 UNITS OF PACKED RED BLOOD CELLS (PRBC'S) AT AN EMERGENCY DEPARTMENT AND WAS SENT HOME. THE EVENT IS CONSIDERED FULLY RESOLVED. IT SHOULD BE NOTED THAT THIS PATIENT IS IN THE CURRENT POST APPROVAL STUDY. ALL SUCH PATIENTS SHOULD BE ON THE RECOMMENDED INR THERAPY OF 1.5-2.0 PLUS A DAILY LOW DOSE ASPIRIN. WITH AN INR REPORTED AT 3.1 UPON ADMISSION, THE PATIENT WAS SIGNIFICANTLY HIGHER THAN THE RECOMMENDATION, AND EXCEEDS EVEN THE HIGH END OF THE STANDARD, INR 2.0-3.0. DESPITE THIS THERE IS NO EVIDENCE PRESENTED TO IDENTIFY A CAUSE OF THE BLEED. THE INSTRUCTIONS FOR USE (IFU) FOR THE PRODUCT LISTS BLEEDING AS A POSSIBLE COMPLICATION OF MECHANICAL HEART VALVE REPLACEMENT. HISTORICALLY, THE CATEGORY OF "MAJOR HEMORRHAGE" OCCURS AT A RATE OF 1.5% PATIENT-YEAR FOR RIGID HEART VALVES. IN THE PROACT STUDY, IN A DIRECT COMPARISON, VALVE REPLACEMENT HIGH RISK CONTROL GROUPS (INR 1.5-2.0) MAJOR BLEEDING RATE OF 1.59% PATIENT-YEAR RATE COMPARED TO THE CONTROL GROUP (INR 2.0-3.0) MAJOR BLEEDING RATE OF 3.94% PATIENT-YEAR. OVER ANTICOAGULATION LIKELY WORSENED THE BLEEDING EVENT BUT THERE IS NO IDENTIFIED CAUSE FOR IT. THEREFORE, NO EVIDENCE THAT THE VALVE CONTRIBUTED TO THE CAUSE OF THE BLEED, THOUGH THE REQUIREMENT FOR ANTICOAGULATION MAY HAVE IMPACTED ITS MAGNITUDE. THE RISK MANAGEMENT FILE THOROUGHLY IDENTIFIES THE PROCESS AND PRODUCT HAZARDS FOR APPROVED INDICATIONS. EACH INDIVIDUAL HAZARD IS MITIGATED AND REDUCED AS LOW AS POSSIBLE BY DESIGN AND PROCESS. POST PRODUCTION RESIDUAL RISK IS COMMUNICATED IN THE PRODUCT'S LABELING AND IFU. NO ACTION NECESSARY. THIS EVENT DOES NOT IDENTIFY ADDITIONAL HAZARDS OR MODIFY THE PROBABILITY AND SEVERITY OF EXISTING HAZARDS. THIS REPORT IS BEING SUBMITTED AS REQUIRED BY FEDERAL REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. FURTHERMORE, THIS REPORT REFLECTS THE EVENT AS ALLEGED BY THE COMPLAINANT AND DOES NOT IMPLY THAT THE INFORMATION REPORTED TO CRYOLIFE IS ACCURATE OR HAS BEEN CONFIRMED BY CRYOLIFE.

    Description of Event or Problem · 0

    ACCORDING TO AN EMAIL ON 11/23/2018: "PATIENT IN THE STUDY HAS EXPERIENCED A COMPLICATION WHICH WAS REGISTERED IN THE DATABASE ON 23 NOVEMBER 2018. THE COMPLICATION ENTERED IS BLEEDING EVENT." ADDITIONAL INFORMATION WAS RECEIVED ON 11/26/2018 VIA EMAIL: "ADDITIONAL INFORMATION WAS RECEIVED FROM THE SITE. INR AT TIME OF EVENT WAS 3.1. PATIENT TREATED IN 'EMERGENCY DEPARTMENT WITH 2 UNITS OF PRBCS AND THEN SENT HOME.' THIS IS ALL OF THE INFORMATION WE HAVE FOR THE EVENT."

    Description of Event or Problem · 0

    ACCORDING TO AN EMAIL ON (B)(6) 2018, : "PATIENT IN THE STUDY HAS EXPERIENCED A COMPLICATION WHICH WAS REGISTERED IN THE DATABASE ON (B)(6) 2018, THE COMPLICATION ENTERED IS BLEEDING EVENT." ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2018, VIA EMAIL: "ADDITIONAL INFORMATION WAS RECEIVED FROM THE SITE. INR AT TIME OF EVENT WAS 3.1. PATIENT TREATED IN 'EMERGENCY DEPARTMENT WITH 2 UNITS OF PRBCS AND THEN SENT HOME.' THIS IS ALL OF THE INFORMATION WE HAVE FOR THE EVENT."

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADDITIONAL INFORMATION WILL BE PROVIDED IN THE FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    ACCORDING TO AN EMAIL ON (B)(6) 2018: "PATIENT IN THE 'SYUDY' HAS EXPERIENCED A COMPLICATION WHICH WAS REGISTERED IN THE DATABASE ON (B)(6) 2018. THE COMPLICATION ENTERED IS BLEEDING EVENT." ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2018 VIA EMAIL: "ADDITIONAL INFORMATION WAS RECEIVED FROM THE SITE. INR AT TIME OF EVENT WAS 3.1. PATIENT TREATED IN 'EMERGENCY DEPARTMENT WITH 2 UNITS OF PRBCS AND THEN SENT HOME.' THIS IS ALL OF THE INFORMATION WE HAVE FOR THE EVENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1015128 ONX AORTIC STANDARD 23 HEART-VALVE, MECHANICAL LWQ ON-X LIFE TECHNOLOGIES, INC. ONXA-23

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| O