BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MASTERS SERIES HEART COATED AORTIC VALVED GRAFT

    MDR report key: 20929042 · Received December 13, 2024

    Report

    Report Number
    2135147-2024-06380
    Event Type
    Malfunction
    Date Received
    December 13, 2024
    Date of Event
    November 5, 2024
    Report Date
    May 5, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LWQ
    UDI-DI
    05415067044099
    PMA / PMN Number
    P810002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 0

    AN EVENT OF LEAFLETS NOT OPENING/CLOSING SMOOTHLY, AND STAINS OBSERVED ON THE VALVE GRAFT WAS REPORTED. THE DEVICE WAS RETURNED TO ABBOTT FOR INVESTIGATION. NO ANOMALIES WERE FOUND WITH THE VALVE LEAFLETS WITH BOTH LEAFLETS ABLE TO FULLY OPEN AND CLOSE WITHOUT RESISTANCE. THE VALVE WAS ABLE TO BE ROTATED WITHOUT DIFFICULTY. THE VALVE WAS SENT FOR FUNCTIONAL TESTING AT THE ENGINEERING TEST LAB, WHICH ENSURES PROPER LEAFLET COAPTATION, WHERE IT MET FUNCTIONAL SPECIFICATIONS. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED, INCLUDING FUNCTIONAL TESTING, AND THE PRODUCT MET ALL SPECIFICATIONS. ADDITIONALLY, THE DEVICE WAS SENT TO THE SCIENCE AND TECHNOLOGY (S&T) LAB FOR FURTHER TESTING WHICH REVEALED THAT THE CONTROL REGION AND FOREIGN MATERIAL SPECTRA SHOWED SIMILAR CHEMICAL COMPOSITIONS BY FOURIER TRANSFORM INFRARED SPECTROSCOPY (FTIR), INDICATING THE FOREIGN MATERIAL (FM) IS LIKELY THE COATING MATERIAL. AS A RESULT OF THIS FINDING, THE REPORTED FOREIGN MATERIAL WAS DETERMINED TO BE A POTENTIAL PRODUCT QUALITY ISSUE. EXCEPTION (ISSUE) IS INITIATED TO FURTHER INVESTIGATE THIS COMPLAINT. THE ISSUE IS BEING ADDRESSED PER INTERNAL OPERATING PROCEDURES. ABBOTT WILL CONTINUE TO TREND THE PERFORMANCE OF THESE DEVICES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2024, A 25MM SJM MASTERS SERIES COATED AORTIC VALVED GRAFT WAS SELECTED FOR IMPLANT. DURING THE PROCEDURE, WHILE SUTURING THE VALVE, THE PHYSICIAN NOTICED STAINS ON THE AORTIC VALVE GRAFT TUBE. THE DEVICE WAS REMOVED AND REPLACED. IT WAS ALSO NOTED THAT THE LEAFLETS DIDN'T OPEN AND CLOSE SMOOTHLY. THERE WERE NO ADVERSE HEALTH CONSEQUENCES TO THE PATIENT. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. THE PATIENT HAS BEEN DISCHARGED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON 05 NOV. 2024, A 25MM SJM MASTERS SERIES COATED AORTIC VALVED GRAFT WAS SELECTED FOR IMPLANT. DURING THE PROCEDURE, WHILE SUTURING THE VALVE, THE PHYSICIAN NOTICED STAINS ON THE AORTIC VALVE GRAFT TUBE. THE DEVICE WAS REMOVED AND REPLACED. IT WAS ALSO NOTED THAT THE LEAFLETS DIDN'T OPEN AND CLOSE SMOOTHLY. THERE WERE NO ADVERSE HEALTH CONSEQUENCES TO THE PATIENT. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. THE PATIENT HAS BEEN DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1857702 MASTERS SERIES HEART COATED AORTIC VALVED GRAFT HEART-VALVE, MECHANICAL LWQ ABBOTT MEDICAL 25CAVGJ-514 00 9202060 05415067044099

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown