BEUDAMED
    FDA Adverse Event Death Summary report: N

    ON-X AORTIC HEART VALVE WITH ANATOMICAL SEWING RING AND EXTENDED HOLDER

    MDR report key: 6295963 · Received February 2, 2017

    Report

    Report Number
    1649833-2017-00015
    Event Type
    Death
    Date Received
    February 2, 2017
    Date of Event
    December 28, 2016
    Report Date
    April 7, 2017
    Manufacturer
    ON-X LIFE TECHNOLOGIES, INC.
    Product Code
    LWQ
    PMA / PMN Number
    P000037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    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

    <P CLASS="">ADDITIONAL INFORMATION FROM THE SURGEON'S NURSE INDICATED THAT THE PATIENT'S CAUSE OF DEATH WAS DUE TO CARDIAC ARREST AND INABILITY TO WEAN FROM BYPASS AND WAS "NOT CAUSED BY THE VALVE." PRE-OPERATIVE COMORBIDITIES INCLUDE CORONARY ARTERY DISEASE (CAD), SEVERE OBESITY, AND AORTIC STENOSIS. OPERATIVE NOTES WERE NOT AVAILABLE TO SEND. </P><P CLASS="">THE MANUFACTURING RECORDS FOR THE ONXANE-19, 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.</P><P CLASS="">THE ONXANE-19 (SN (B)(4)) WAS IMPLANTED (B)(6) 2016. FIELD REPORTS INDICATE PATIENT DIED DAY OF SURGERY DUE TO CARDIAC ARREST AND INABILITY TO WEAN FROM BYPASS "NOT CAUSED BY THE VALVE." PREOPERATIVE COMORBIDITIES INCLUDE CAD, SEVERE OBESITY, AND AORTIC STENOSIS. IN AN ANALYSIS OF AORTIC VALVE OPERATIONS IN THE STS DATABASE FROM 2002 TO 2010, 80% OF PATIENTS HAD A PREDICTED RISK OF MORTALITY (PROM) OF <4% AND AN ACTUAL MEAN MORTALITY RATE OF 1.4%. FOURTEEN PERCENT HAD A PROM OF 4% TO 8% AND AN ACTUAL MEAN MORTALITY RATE OF 5.1%, AND 6% OF PATIENTS HAD A PROM OF >8% AND AN ACTUAL MORTALITY RATE OF 11.1% [NISHIMURA ET AL. 2014]. DEATHS IN THIS EVALUATION ARE UNRELATED TO THE DEVICE IMPLANTED AND REPRESENT OUTCOMES DUE TO THE TRAUMA OF SURGERY. IN ADDITION, WHILE THESE ARE GENERAL EVALUATIONS, THE PRESENCE OF MULTIPLE COMORBIDITIES IN THE PRESENT CASE INCREASED THE RISK OF A NEGATIVE OUTCOME. IT IS LIKELY THAT THE TRAUMA OF SURGERY COMBINED WITH PREOPERATIVE COMORBIDITIES RESULTED IN A SURGICAL DEATH UNRELATED TO THE VALVE.</P><P CLASS="">THIS EVENT DOES NOT IDENTIFY ADDITIONAL HAZARDS OR MODIFY THE PROBABILITY AND SEVERITY OF EXISTING HAZARDS.&NBSP;

    Description of Event or Problem · 1

    IMPLANT REGISTRATION CARD RECEIVED STATED FEMALE PATIENT RECEIVED ONXANE-19 (SN (B)(4)) ON (B)(6) 2016 AND ¿PT EXPIRED AFTER IMPLANT.¿ OBITUARY CONFIRMS DATE OF DEATH AS (B)(6) 2016.

    Description of Event or Problem · 1

    IMPLANT REGISTRATION CARD RECEIVED STATED FEMALE PATIENT RECEIVED ONXANE-19 (SN (B)(4)) ON (B)(6) 2016 AND ¿PT EXPIRED AFTER IMPLANT.¿ OBITUARY CONFIRMS DATE OF DEATH AS (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81102 ON-X AORTIC HEART VALVE WITH ANATOMICAL SEWING RING AND EXTENDED HOLDER HEART-VALVE, MECHANICAL LWQ ON-X LIFE TECHNOLOGIES, INC. ONXANE-19

    Patients

    Seq Age Sex Outcome Treatment
    1 65 DA Death