BEUDAMED
    FDA Adverse Event Death Summary report: N

    ON-X PROSTHETIC AORTIC VALVE WITH ANATOMIC SEWING RING

    MDR report key: 8019030 · Received October 30, 2018

    Report

    Report Number
    1649833-2018-00161
    Event Type
    Death
    Date Received
    October 30, 2018
    Date of Event
    August 17, 2018
    Report Date
    December 28, 2018
    Manufacturer
    ON-X LIFE TECHNOLOGIES, INC.
    Product Code
    LWQ
    PMA / PMN Number
    P000037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED TO PRODUCT CODE LWQ, COMMON DEVICE NAME "HEART-VALVE, MECHANICAL." THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADDITIONAL INFORMATION WILL BE PROVIDED IN THE FOLLOW-UP REPORT.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    PRODUCT CODE - LWQ. COMMON DEVICE NAME - HEART-VALVE, MECHANICAL. THE MANUFACTURING RECORDS FOR THE ONXAN-21, SN: (B)(4) WERE REVIEWED AND IT WAS CONFIRMED THAT ALL RECORDS WERE CONTROLLED, AVAILABLE FOR REVIEW, AND MET ALL SPECIFICATIONS PER THE DEVICE MASTER RECORD. ALL LOTS PASSED FUNCTIONAL TESTING AND MET RELEASE SPECIFICATIONS. DURING THE INVESTIGATION NO NON-CONFORMANCES OR DEVIATIONS WERE NOTED. THE ONXAN-21, SN: (B)(4) WAS IMPLANTED (B)(6) 2018 IN THE AORTIC POSITION OF A (B)(6) YEAR-OLD MALE. THIS WAS HIS THIRD HEART OPERATION. HIS SPOUSE INDICATED HE HAD A CONGENITAL BICUSPID VALVE AND RECEIVED HIS FIRST "COAPTATION" AT THE AGE OF (B)(6). ABOUT 10.5 YEARS AGO, HE HAD A TISSUE VALVE IMPLANTED WHICH WAS REPLACED THIS PAST (B)(6) BY THE ON-X AORTIC PROSTHESIS. HE HAD BEEN DOING VERY WELL, WAS RECOVERED FROM HIS THERAPY, BUT DIED (B)(6) 2018 (137 DAYS POSTOP) AFTER SUDDENLY SLUMPING OVER, NOT BREATHING. ALTHOUGH THE HOSPITAL RULED THE CAUSE OF DEATH AS "V-FIB", ACCORDING TO THE SPOUSE'S RECOLLECTION, IT WOULD MORE LIKELY BE CLASSIFIED AS A LATE CARDIAC DEATH WHICH MAY OR MAY NOT BE VALVE-RELATED. IT SHOULD BE NOTED, HOWEVER, THAT DEATH CAUSED BY HEART FAILURE IN PATIENTS WITH ADVANCED MYOCARDIAL DISEASE AND SATISFACTORILY FUNCTIONING CARDIAC VALVES WOULD NOT BE COUNTED AS A VALVE-RELATED MORTALITY (AKINS 2008). AN E-MAIL FROM THE SPOUSE TO THE ON-X SURGEON WENT UNANSWERED, SO WE HAVE NO INSIGHT FROM THAT SOURCE. WHILE THE GUIDELINES FOR REPORTING MORTALITY MAY CLASSIFY SUDDEN, UNEXPLAINED DEATH AS VALVE-RELATED, WE DON'T KNOW IF THE PATIENT'S "V-FIB" WAS DUE TO ADVANCED MYOCARDIAL DISEASE AND, CONSEQUENTLY, DO NOT HAVE ENOUGH INFORMATION TO KNOW TO ANY DEGREE OF MEDICAL CERTAINTY WHAT, IF ANY, RELATIONSHIP THE DEATH HAD TO THE ON-X VALVE(S) . THE INSTRUCTIONS FOR USE FOR THE ON-X VALVE LISTS CARDIAC ARRHYTHMIA AS A POSSIBLE COMPLICATION OF MECHANICAL HEART VALVE REPLACEMENT WHICH MAY RESULT IN DEATH [IFU]. THE CAUSE OF SUCH ARRHYTHMIA IN THIS CASE IS UNKNOWN. THE DIAGNOSED CAUSE OF DEATH IS ARRHYTHMIA (VENTRICULAR FIBRILLATION). HOWEVER, THERE IS NOT ENOUGH INFORMATION PROVIDED TO TIE THIS TO THE VALVE AND SO WE DO NOT KNOW WHAT, IF ANY, RELATIONSHIP THE DEATH OF THE PATIENT HAS TO THE VALVE. NO FURTHER ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    ACCORDING TO INITIAL REPORTS, PATIENT WITH AN ON-X AORTIC VALVE IMPLANTED ON THE (B)(6) 2018 HAD SUDDENLY DIED ON (B)(6) 2018. THE CAUSE OF DEATH WAS "VFIB". THE PATIENT WAS DOING VERY WELL AND HAD JUST FINISHED THERAPY AT THE END OF JULY AND WAS WATCHING TV ON THE EVENING OF (B)(6), WHEN HE SUDDENLY SLUMPED OVER AND WAS NOT BREATHING. PATIENT'S WIFE PERFORMED CPR UNTIL THE AMBULANCE ARRIVED, THEN HE WAS DECLARED DECEASED ONCE THEY ARRIVED AT THE HOSPITAL. PATIENT HAD 3 HEART SURGERIES TOTAL IN HIS LIFE, HIS FIRST "COAPTATION" AT THE AGE OF (B)(6) SINCE HE WAS BORN WITH A BICUSPID AVR. A TISSUE VALVE WAS IMPLANTED ~10.5 YEARS AGO, AND THEN THE ON-X AORTIC VALVE IN 2018.

    Description of Event or Problem · 1

    ACCORDING TO INITIAL REPORTS, PATIENT WITH AN ON-X AORTIC VALVE IMPLANTED ON THE (B)(6) 2018 HAD SUDDENLY DIED ON (B)(6) 2018. THE CAUSE OF DEATH WAS "VFIB". THE PATIENT WAS DOING VERY WELL AND HAD JUST FINISHED THERAPY AT THE END OF (B)(6) AND WAS WATCHING TV ON THE EVENING OF (B)(6), WHEN HE SUDDENLY SLUMPED OVER AND WAS NOT BREATHING. PATIENT'S WIFE PERFORMED CPR UNTIL THE AMBULANCE ARRIVED, THEN HE WAS DECLARED DECEASED ONCE THEY ARRIVED AT THE HOSPITAL. PATIENT HAD 3 HEART SURGERIES TOTAL IN HIS LIFE, HIS FIRST "COAPTATION" AT THE AGE OF (B)(6) SINCE HE WAS BORN WITH A BICUSPID AVR. A TISSUE VALVE WAS IMPLANTED ~10.5 YEARS AGO, AND THEN THE ON-X AORTIC VALVE IN 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    861162 ON-X PROSTHETIC AORTIC VALVE WITH ANATOMIC SEWING RING HEART-VALVE, MECHANICAL LWQ ON-X LIFE TECHNOLOGIES, INC. ONXAN-21

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death