BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 12575969 · Received October 5, 2021

    Report

    Report Number
    12575969
    Event Type
    Malfunction
    Date Received
    October 5, 2021
    Date of Event
    September 3, 2021
    Report Date
    September 9, 2021
    Manufacturer
    ON-X LIFE TECHNOLOGIES, INC.
    Product Code
    LWQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    GA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DOCTOR ASKED FOR 23MM AORTIC VALVE. I SHOWED THE BOX TO HIM BEFORE OPENING IT AND CAREFULLY HANDED IT TO THE SCRUB TECH'S STERILE FIELD. I GAVE SCRUB TECH AN ON-X PROSTHETIC HEART VALVE (AORTIC) 23MM, EXPIRATION: 09/29/2026. I PROCEEDED TO CHART THE IMPLANT AND FILL UP THE INSERTS FROM THE BOX WHEN THEY ASKED FOR ANOTHER VALVE (21MM). I SHOWED THE BOX TO DOCTOR BEFORE OPENING IT AND ASKED THE TECH WHY THEY NEEDED ANOTHER ONE. SCRUB TECH VERBALIZED: "[DOCTOR] WAS TRYING TO INSERT/REPOSITION THE VALVE WHEN IT BROKE." THEN HE SHOWED ME VALVE WITH THE BROKEN PIECES IN A BOWL. BEFORE THE CASE ENDED, WE SUGGESTED TO DO AN X-RAY BUT DOCTOR REFUSED. HE SAID HE GOT ALL THE PIECES OUT. MECHANICAL HEART VALVE BROKE DURING SURGERY. THIS WAS AN ON-X PROSTHETIC HEART VALVE WITH CONFORM-X SEWING RING SIZE 23MM, REF ONXACE-23, EXP DATE: 2026-09-29. THE VALVE PIECES WERE SAVED, AS WAS THE ORIGINAL PACKAGING. RISK WAS NOTIFIED THE DAY IT HAPPENED. INFORMATION PROVIDED TO REGULATORY AFFAIRS FOR REPORTING TO FDA. SUPPLY CHAIN TO FOLLOW UP WITH VENDOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1475945 ON-X AORTIC HEART VALVE WITH CONFORM-X SEWING RING AND EXTENDED HOLDER HEART-VALVE, MECHANICAL LWQ ON-X LIFE TECHNOLOGIES, INC. ONXACE-23

    Patients

    Seq Age Sex Outcome Treatment
    1 15330 DA