BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON-X PROSTHETIC HEART VALVE

    MDR report key: 5366279 · Received January 14, 2016

    Report

    Report Number
    1649833-2016-70002
    Event Type
    Injury
    Date Received
    January 14, 2016
    Date of Event
    November 18, 2013
    Report Date
    January 14, 2016
    Manufacturer
    ON-X LIFE TEHCNOLOGIES, INC.
    Product Code
    DYE
    UDI-DI
    00851788001464
    PMA / PMN Number
    P000037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE PRESUMABLY DISCARDED AT HOSPITAL, CANNOT FULLY INVESTIGATE. REVIEW OF DEVICE HISTORY RECORDS INDICATES THE VALVE WAS BUILT PER SPECIFICATIONS.

    Description of Event or Problem · 1

    OCCURRED IN THE US. DURING INPUT OF IMPLANT REGISTRATION CARD INFORMATION INTO THE TRACKING SYSTEM, IT WAS NOTED THAT THERE WERE 2 AORTIC VALVES FOR THE SAME PATIENT. THE SURGEON'S OFFICE WAS CONTACTED TO INQUIRE ABOUT MORE INFORMATION. WE RECEIVED THE OPERATIVE NOTES FOR THE 2ND VALVE IMPLANT, DESCRIBING THE REASON FOR RE-OPERATION AS ENDOCARDITIS. (POST-OPERATIVE - LATE). PER OPERATIVE NOTES, PATIENT HAD COMPLAINED OF NIGHT SWEATS. EVIDENCE OF CONGESTIVE HEART FAILURE UPON ADMISSION. ECHO REVEALED SEVERE AORTIC INSUFFICIENCY. RE-OP'D WITH ONXAE-23MM ON-X VALVE. PER OPERATIVE NOTES: "THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TRANSFERRED TO ICU IN CRITICAL BUT STABLE CONDITION". PER AATS/STS GUIDELINES, ENDOCARDITIS IS DEFINED AS "VALVE-RELATED", AND IS THUS REPORTABLE. THIS IS AN EXPECTED ADVERSE EVENT, OCCURRING WELL-WITHIN EXPECTED FREQUENCY (N=39, 0.02%/PTYR PER P000037/R014 ANNUAL REPORT). NO TREND IS SEEN. RE-OPERATION OCCURRED WHICH IS CLASSIFIED AS A "SERIOUS INJURY". THE VALVE IS UNAVAILABLE FOR RETURN, PRESUMABLY DISCARDED AT THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24733 ON-X PROSTHETIC HEART VALVE MECHANICAL HEART VALVE DYE ON-X LIFE TEHCNOLOGIES, INC. ONXACE 00851788001464

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention