BEUDAMED
    FDA Adverse Event Death Summary report: N

    ON-X AORTIC PROSTHETIC HEART VALVE

    MDR report key: 7728876 · Received July 27, 2018

    Report

    Report Number
    1649833-2018-00132
    Event Type
    Death
    Date Received
    July 27, 2018
    Report Date
    October 24, 2018
    Manufacturer
    ON-X LIFE TECHNOLOGIES, INC.
    Product Code
    LWQ
    PMA / PMN Number
    P000037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    DATE OF SURGERY FOR THE FOLLOWING EVENTS IS UNKNOWN, THEREFORE MANUFACTURING RECORDS WERE NOT REVIEWED. A JOURNAL ARTICLE DESCRIBING THE RESULTS OF EXAMINING SUBCLINICAL HEMOLYSIS ATTRIBUTED TO ISOLATED ON-X PROSTHETIC HEART VALVES IMPLANTED IN THE AORTIC POSITION OF 84 CONSECUTIVE PATIENTS WHO WERE RETROSPECTIVELY GROUPED INTO THOSE WITH FACTORS ASSOCIATED WITH PROSTHESIS-RELATED HEMOLYSIS (GROUP H, N=12) AND THOSE WITHOUT SUCH FACTORS (GROUP C, N=72). ALTHOUGH BOTH GROUPS IMPROVED THEIR NEW YORK HEART ASSOCIATION (NYHA) CLASSIFICATION COMPARED TO THEIR PREOPERATIVE ASSESSMENT, GROUP H WAS LESS IMPROVED THAN GROUP C AFTER A FOLLOW-UP PERIOD OF 66.7 ± 10.2 MONTHS. IT WAS NOTED THAT AMONG GROUP H, THE HIGHER INCIDENCES OF HEMOLYSIS CORRESPONDED TO SMALLER VALVE SIZES, I.E. THE SMALLER THE VALVE, THE MORE PRONOUNCED THE HEMOLYSIS. THE ARTICLE CONCLUDES THAT WHILE THE HEMOLYSIS GENERATED BY SOME CASES INVOLVING THE ON-X VALVES ARE DEEMED NOT CLINICALLY SIGNIFICANT, THE LONG-TERM EFFECTS DO SHOW LESS IMPROVEMENT FOR THIS GROUP THAN THOSE CASES WITHOUT THE PRESENCE OF DETECTIBLE HEMOLYSIS. IT WAS NOTED IN THE ARTICLE THAT 3 PATIENTS IN THE ORIGINAL GROUP OF 93 POTENTIAL PARTICIPANTS DIED DURING THE FOLLOW-UP PERIOD AND WERE NOT INCLUDED IN THE FINAL COHORT OF 84. NO EXPLANATION FOR THE DEATHS WAS PROVIDED IN THE ARTICLE, BUT SUBSEQUENT CORRESPONDENCE WITH THE LEAD AUTHOR RESULTED IN THE FOLLOWING: "I WOULD LIKE TO STRESS THAT 3 PATIENTS DIED NOT DUE TO PROSTHESIS-RELATED REASONS." FROM THIS STATEMENT WE CAN CONCLUDE THAT THE ON-X VALVE IS NOT IMPLICATED IN THE DEATHS OF THESE THREE. NEVERTHELESS, WHILE THE ON-X VALVE MAY NOT BE IMPLICATED HERE, THE INSTRUCTIONS FOR USE DO RECOGNIZE AND LIST DEATH AS A POTENTIAL COMPLICATION ASSOCIATED WITH THE USE OF THIS PROSTHETIC HEART VALVE. CORRESPONDENCE WITH THE LEAD AUTHOR INDICATES THE ON-X VALVE IS NOT TO BE CONSIDERED RESPONSIBLE FOR THE DEATHS OF THREE ON-X RECIPIENTS. THE CAUSE(S) ARE NOT OTHERWISE IDENTIFIED. NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    ACCORDING TO THE PUBLICATION, "LATE SUBCLINICAL HEMOLYSIS AND LONG-TERM OUTCOMES AFTER AORTIC VALVE REPLACEMENT WITH ON-X MECHANICAL PROSTHESES - A PRELIMINARY SINGLE-CENTER REPORT", THE PROSPECTIVE STUDY INCLUDED 84 CONSECUTIVE PATIENTS AGED 58.3 ±10.3 YEARS WHO UNDERWENT AVR. THEY WERE RETROSPECTIVELY SPLIT INTO GROUP H (N = 12; 14.3%) WITH PROSTHESIS-RELATED SUBCLINICAL HEMOLYSIS AND A CONTROL GROUP (C; N = 72; 85.7%). ALL OPERATIONS WERE PERFORMED VIA MEDIAN STERNOTOMY USING CARDIO-PULMONARY BYPASS. AT THE END OF FOLLOW-UP, ECHOCARDIOGRAPHY WAS CARRIED OUT AND BLOOD SAMPLES FOR MORPHOLOGY AND BIOCHEMISTRY (LACTATE DEHYDROGENASE (LDH), BILIRUBIN, HAPTOGLOBIN) WERE TAKEN. THREE PATIENTS DIED DURING THE FOLLOW-UP PERIOD THAT LASTED 66.7 ± 10.2 MONTHS.

    Description of Event or Problem · 1

    ACCORDING TO THE PUBLICATION, "LATE SUBCLINICAL HEMOLYSIS AND LONG-TERM OUTCOMES AFTER AORTIC VALVE REPLACEMENT WITH ON-X MECHANICAL PROSTHESES - A PRELIMINARY SINGLE-CENTER REPORT", THE PROSPECTIVE STUDY INCLUDED 84 CONSECUTIVE PATIENTS AGED 58.3 ±10.3 YEARS WHO UNDERWENT AVR. THEY WERE RETROSPECTIVELY SPLIT INTO GROUP H (N = 12; 14.3%) WITH PROSTHESIS-RELATED SUBCLINICAL HEMOLYSIS AND A CONTROL GROUP (C; N = 72; 85.7%). ALL OPERATIONS WERE PERFORMED VIA MEDIAN STERNOTOMY USING CARDIO-PULMONARY BYPASS. AT THE END OF FOLLOW-UP, ECHOCARDIOGRAPHY WAS CARRIED OUT AND BLOOD SAMPLES FOR MORPHOLOGY AND BIOCHEMISTRY (LACTATE DEHYDROGENASE (LDH), BILIRUBIN, HAPTOGLOBIN) WERE TAKEN. THREE PATIENTS DIED DURING THE FOLLOW-UP PERIOD THAT LASTED 66.7 ± 10.2 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570953 ON-X AORTIC PROSTHETIC HEART VALVE HEART-VALVE, MECHANICAL LWQ ON-X LIFE TECHNOLOGIES, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death