BEUDAMED
    FDA Adverse Event Death Summary report: N

    ON-X AORTIC VALVE UNKNOWN CONFIGURATION

    MDR report key: 6177946 · Received December 15, 2016

    Report

    Report Number
    1649833-2016-00079
    Event Type
    Death
    Date Received
    December 15, 2016
    Report Date
    February 22, 2017
    Manufacturer
    ON-X LIFE TECHNOLOGIES, INC.
    Product Code
    LWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLES ATTEMPTS WERE MADE TO OBTAIN THE FOLLOWING CLARIFYING INFORMATION WITHOUT SUCCESS: SPECIFIC PRODUCT CODE AND SERIAL NUMBER, DATE OF IMPLANT, DATE OF EVENT/DEATH, DATE OF INTERVENTION, HISTORIC RECORD OF INR PRECEDING AND AT TIME OF EVENT, PERTINENT PATIENT COMORBIDITIES. THE MANUFACTURING RECORDS FOR THE ON-X AORTIC VALVE WERE NOT PERFORMED AS THE PRODUCT CODE, SERIAL NUMBER, AND DEFINITIVE DATE OF IMPLANT WERE UNAVAILABLE. AS SUCH, THE SYSTEM COULD NOT BE QUERIED FOR POTENTIAL SERIAL NUMBERS SHIPPED TO THE DISTRIBUTOR AND ULTIMATELY TO THE HOSPITAL. THE CASE CANNOT BE VERIFIED AS AN ON-X CASE AS NO SERIAL NUMBER, DATE OF SURGERY, PATIENT INFORMATION OR OTHER IMPLANTING INFORMATION WAS PROVIDED. THE FIELD REPORT EMPHASIZES THAT ALTHOUGH THE PATIENT WAS NON-COMPLIANT WITH ANTICOAGULATION, INCLUDING NO ASPIRIN AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU), THE DEATH OF THE PATIENT WAS NOT VALVE-RELATED. YET, NO EXPLANATION WAS PROVIDED AS TO WHAT IT WAS ATTRIBUTED. SIMILARLY, CLOTTING WAS REPORTED, BUT AGAIN THIS WAS NOT ATTRIBUTED TO THE VALVE PER THE FIELD REPORT. TO WHAT IT WAS ATTRIBUTED INSTEAD WAS NOT STATED. THERE IS TOO LITTLE CLINICAL INFORMATION OR MEDICAL EVIDENCE PROVIDED TO DRAW ANY CONCLUSIONS FROM THIS CASE AND A DEFINITIVE CORRELATION BETWEEN THE VALVE AND THE REPORTED EVENTS CANNOT BE ESTABLISHED. THIS EVENT DOES NOT IDENTIFY ADDITIONAL HAZARDS OR MODIFY THE PROBABILITY AND SEVERITY OF EXISTING HAZARDS.

    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 THE INITIAL REPORT FROM THE REP, "WE WERE TOLD THAT MORE THAN TWO YEARS AGO, A PSYCHIATRIC PATIENT WAS ADMITTED WITH SEVERAL COMORBIDITIES AND THE SURGEON AGREED TO OPERATE AS A LAST RESORT TO TRY AND SAVE HER. THE PATIENT WAS NON COMPLIANT WITH WARFARIN AND THERE WAS SOME CLOTTING BUT THIS WAS NOT BECAUSE OF THE VALVE. THE PATIENT DIED LATER IN THE YEAR BUT THIS WAS ALSO NOT BECAUSE OF THE VALVE. ASPIRIN WAS NOT GIVEN EVEN FOR THE FIRST THREE MONTHS. THERE WAS NO OTHER INFORMATION THAT COULD BE GIVEN ABOUT THE INCIDENT, AS A COMPLAINT WAS NOT MADE AND IT HAD OCCURRED A LONG TIME AGO." PATIENT IMPACT REPORTED AS "THERE WAS NO PATIENT INJURY, THE PATIENT DIED LATER IN THE YEAR DUE TO OTHER ISSUES."

    Description of Event or Problem · 1

    ACCORDING TO THE INITIAL REPORT FROM THE REP, "WE WERE TOLD THAT MORE THAN TWO YEARS AGO, A PSYCHIATRIC PATIENT WAS ADMITTED WITH SEVERAL COMORBIDITIES AND THE SURGEON AGREED TO OPERATE AS A LAST RESORT TO TRY AND SAVE HER. THE PATIENT WAS NON COMPLIANT WITH WARFARIN AND THERE WAS SOME CLOTTING BUT THIS WAS NOT BECAUSE OF THE VALVE. THE PATIENT DIED LATER IN THE YEAR BUT THIS WAS ALSO NOT BECAUSE OF THE VALVE. ASPIRIN WAS NOT GIVEN EVEN FOR THE FIRST THREE MONTHS. THERE WAS NO OTHER INFORMATION THAT COULD BE GIVEN ABOUT THE INCIDENT, AS A COMPLAINT WAS NOT MADE AND IT HAD OCCURRED A LONG TIME AGO." PATIENT IMPACT REPORTED AS "THERE WAS NO PATIENT INJURY, THE PATIENT DIED LATER IN THE YEAR DUE TO OTHER ISSUES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    825366 ON-X AORTIC VALVE UNKNOWN CONFIGURATION HEART-VALVE, MECHANICAL LWQ ON-X LIFE TECHNOLOGIES, INC. ONX UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death