BEUDAMED
    FDA Adverse Event Death Summary report: N

    OPTIFORM PROSTHETIC MITRAL HEART VALVE

    MDR report key: 12598202 · Received October 8, 2021

    Report

    Report Number
    3005687633-2021-00159
    Event Type
    Death
    Date Received
    October 8, 2021
    Date of Event
    September 8, 2021
    Report Date
    October 7, 2021
    Manufacturer
    CORCYM S.R.L.
    Product Code
    LWQ
    UDI-DI
    08022057012852
    PMA / PMN Number
    P900060/S019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLETE MANUFACTURING AND MATERIAL RECORDS REVIEW FOR THE DEVICE MODEL F7-027 AND SN (B)(4) HAS BEEN PERFORMED. THE RESULTS CONFIRMED THAT THE DEVICE SATISFIED ALL MATERIAL, VISUAL AND PERFORMANCE STANDARDS REQUIRED AT THE TIME OF MANUFACTURE AND RELEASE. SINCE THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER (NOT EXPLANTED), NO FURTHER INVESTIGATION IS POSSIBLE AT THIS TIME. BASED ON THE AVAILABLE INFORMATION, IT IS NOT POSSIBLE TO ESTABLISH A DEFINITIVE ROOT CAUSE FOR THE REPORTED EVENT. HOWEVER, FROM THE DOCUMENT REVIEW PERFORMED, NO MANUFACTURING DEFICIENCIES WERE IDENTIFIED. SINCE IT IS REPORTED THAT THE DEVICE MODEL F7-027 WAS CHECKED AT THE END OF THE SURGERY AND DURING THE EMERGENCY ULTRASOUND, AND NO ANOMALIES WERE IDENTIFIED, THERE IS NO EVIDENCE SUGGESTING A DEVICE MALFUNCTION WHICH COULD HAVE CONTRIBUTED TO THE EVENT. ULTIMATELY, SINCE NO FURTHER INFORMATION NOR MEDICAL JUDGMENT ON THE EVENT WAS PROVIDED, THE ROOT CAUSE REMAINS UNKNOWN AT THIS TIME. SHOULD THE MANUFACTURER RECEIVE ADDITIONAL INFORMATION IN THE FUTURE, A FOLLOW UP REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    ON (B)(6) 2021 THE PATIENT UNDERWENT AORTIC AND MITRAL VALVE REPLACEMENT WITH CORCYM DEVICES DUE TO LESIONS ON BOTH VALVES. THE PATIENT RECEIVED AN OPTIFORM SIZE 27 IN MITRAL POSITION AND A TOP HAT SIZE 21 IN AORTIC POSITION. THE DEVICES WERE SAFELY IMPLANTED DURING THE SURGERY AND PATIENT DID WELL DURING SURGERY. THERE WAS NO ABNORMALITY OR MALFUNCTION NOTED ON THE VALVE DURING SURGERY. THE VALVES WERE TESTED AFTER IMPLANTATION AND CONFIRMED THE POSITION AND OPENING AND CLOSING FUNCTION WAS GOOD. AFTER THE OPERATION, THE HEART RATE AND BLOOD PRESSURE WERE STABLE, SO THE PATIENT WAS THEN TRANSFERRED TO ICU FOR OBSERVATION. TWO HOURS POST-OPERATION, THE PATIENT HAD A SUDDEN LOSS OF BLOOD PRESSURE (BLOOD PRESSURE 0), BUT THE HEARTBEAT REMAINED. THEN, THE PATIENT DIED. THE EMERGENCY ULTRASOUND SHOWED INADEQUATE OPENING AND CLOSING MOTION FOR S5 VALVE. SINCE NO FURTHER INVESTIGATION ON THE PATIENT WAS POSSIBLE, THE SITE COULD NOT ASSESS THE RELATIONSHIP BETWEEN THE DEVICES AND THE EVENT, NOR IF THE DEVICES MALFUNCTIONED OR NOT. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1498645 OPTIFORM PROSTHETIC MITRAL HEART VALVE MECHANICAL HEART VALVE PROSTHESIS LWQ CORCYM S.R.L. CPHV 08022057012852

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death