BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON-X CONFORM-X AORTIC PROSTHETIC HEART VALVE

    MDR report key: 4260745 · Received November 14, 2014

    Report

    Report Number
    1649833-2014-00014
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Date of Event
    September 26, 2014
    Report Date
    November 14, 2014
    Manufacturer
    ON-X LIFE TECHNOLOGIES, INC.
    Product Code
    LWQ
    PMA / PMN Number
    P000037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    VALVE HAS BEEN RETURNED, INVESTIGATION NOT YET COMPLETED. IN ALL PAST CASES OF CARBON PART BREAKAGE, THE INVESTIGATION CONCLUSION WAS "IATROGENIC", IE, SOME SORT OF IMPROPER, ROUGH TREATMENT OF THE VALVE. THERE HAS BEEN NO STRUCTURAL DYSFUNCTION OF FAILURE OF THE ON-X PROSTHETIC OF THE INVESTIGATION IS EXPECTED TO BE SIMILAR TO THAT IN THE PAST. WHEN RELEVANT FURTHER INFORMATION BECOMES AVAILABLE, A FOLLOW-UP MDR WILL BE FILED.

    Description of Event or Problem · 1

    DURING IMPLANTATION, A 2 MM PIECE OF THE CARBON HOUSING WAS BROKEN. THE 2 MM PIECE WAS REMOVED. THE VALVE WAS EXPLANTED AND A NEW/DIFFERENT VALVE WAS IMPLANTED IN ITS PLACE. THE 2 MM PIECE WAS DISCARDED AT THE HOSPITAL. THE VALVE HOUSING IS BEING INVESTIGATED FOR FRACTURE ANALYSIS AT AN INDEPENDENT LAB TO DETERMINE THE ORIGIN AND POTENTIAL CAUSE OF THE CRACK. THIS IS AN INITIAL REPORT. CARBON PART BREAKAGE IS SEPARATELY TRACKED TO ENSURE NO TRENDS OR SYSTEMIC ASSIGNABLE CAUSE. CURRENTLY, ALL HAVE OCCURRED INTRA-OPERATIVELY AND ROOT CAUSE FOR ALL HAVE BEEN KNOWN OR SHOWN TO BE IATROGENIC IN NATURE, AND NOT DUE TO PRODUCT DEFECT OR MALFUNCTION. SUCH BREAKAGE HAS OCCURRED AT A RECURRENCE RATE OF ABOUT 65 PPM. THERE WILL BE A FOLLOW UP AFTER MANUFACTURER'S INVESTIGATION. PER DISTRIBUTOR-PROVIDED INFORMATION, THE PATIENT IS IN GOOD CONDITION AFTER THE SURGERY, WITHOUT ANY COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738826 ON-X CONFORM-X AORTIC PROSTHETIC HEART VALVE MECHANICAL HEART VALVE LWQ ON-X LIFE TECHNOLOGIES, INC. ONXACE

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other