BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONX AORTIC CONFORM EXT 23

    MDR report key: 6439890 · Received March 28, 2017

    Report

    Report Number
    1649833-2017-00029
    Event Type
    Injury
    Date Received
    March 28, 2017
    Date of Event
    January 12, 2017
    Report Date
    May 16, 2017
    Manufacturer
    ONX LIFE TECHNOLOGIES, INC.
    Product Code
    LWQ
    PMA / PMN Number
    P000037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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

    ACCORDING TO OPERATIVE NOTES RECEIVED FROM THE SURGEON 03/03/2017, ¿IT NEEDS TO BE MENTIONED THAT A 21MM ON-X VALVE WAS SUTURED INTO PLACE. AT FIRST, A 23 WAS ATTEMPTED, BUT WOULD NOT INSERT TO THE INTERPORTION OF THE ANNULUS. EVALUATION FOR ANNULAR ENLARGEMENT WAS MADE, BUT DISCARDED. THE SUBVALV[UL]AR AND SINOTUBULAR AREAS WERE LIMITED, AND ENLARGING THE ANNULUS WOULD HAVE MINIMAL EFFECT ON OUTFLOW SIZE¿2-0 TI-CRON PLEDGETED SUTURES WERE PASSED AROUND THE ENTIRE CIRCUMFERENCE OF THE VALVE. THEY WERE THEN SUTURED INTO THE SEWING RING OF 23-MM ON-X PROSTHESIS; HOWEVER, THE INTRALUMINAL FLOW ASPECT OF THE VALVE COULD NOT BE PASSED INTO THE ANNULUS. THEREFORE, THE VALVE WAS SIMILARLY REPLACED WITH A 21[ON-X PROSTHETIC AORTIC VALVE WITH CONFORM-X SEWING RING AND EXTENDED HOLDER [ONXACE-21]]. ONCE THE VALVE WAS SEATED, THERE WAS EXCELLENT OPPOSITION OF TISSUES. THE AORTOTOMY WAS CLOSED USING A RUNNING 4-0 PROLENE SUTURE.¿ BASED ON THE INFORMATION OBTAINED FROM THE SURGEON, THERE IS NO ALLEGATION OF DEFICIENCY OR REPORT OF ADVERSE PATIENT IMPACT. THEREFORE, THIS COMPLAINT WILL BE VOIDED. IF SPECIFIC DETAILS BECOME AVAILABLE PERTAINING TO THE INITIALLY REPORTED INFORMATION, THEY WILL BE EVALUATED AND THE COMPLAINT WILL BE REOPENED. NO FURTHER ACTION REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    PROCEDURE PERFORMED: CORONARY ARTERY BYPASS GRAFTING X1 AND AORTIC VALVE REPLACEMENT. ACCORDING TO THE SURGEON, "A 21MM ON-X VALVE WAS SUTURED INTO PLACE. AT FIRST, A 23 WAS ATTEMPTED, BUT WOULD NOT INSERT TO THE INTERPORTION OF THE ANNULUS. EVALUATION FOR ANNULAR ENLARGEMENT WAS MADE, BUT DISCARDED. THE [SUBVALVULAR] AND SINOTUBULAR AREAS WERE LIMITED, AND ENLARGING THE ANNULUS WOULD HAVE MINIMAL EFFECT ON OUTFLOW SIZE.... ONCE THE VALVE WAS SEATED, THERE WAS EXCELLENT APPOSITION OF TISSUES."

    Description of Event or Problem · 1

    PROCEDURE PERFORMED: CORONARY ARTERY BYPASS GRAFTING X1 AND AORTIC VALVE REPLACEMENT. ACCORDING TO THE SURGEON, "A 21MM ONX VALVE WAS SUTURED INTO PLACE. AT FIRST, A 23 WAS ATTEMPTED, BUT WOULD NOT INSERT TO THE INTERPORTION OF THE ANNULUS. EVALUATION FOR ANNULAR ENLARGEMENT WAS MADE, BUT DISCARDED. THE [SUBVALVULAR] AND SINOTUBULAR AREAS WERE LIMITED, AND ENLARGING THE ANNULUS WOULD HAVE MINIMAL EFFECT ON OUTFLOW SIZE.... ONCE THE VALVE WAS SEATED, THERE WAS EXCELLENT APPOSITION OF TISSUES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223466 ONX AORTIC CONFORM EXT 23 HEART VALVE MECHANICAL LWQ ONX LIFE TECHNOLOGIES, INC. ONXACE23

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other