BEUDAMED
    FDA Adverse Event Death Summary report: N

    CROWN PRT PERICARDIAL HEART VALVE

    MDR report key: 5685896 · Received May 27, 2016

    Report

    Report Number
    3004478276-2016-00058
    Event Type
    Death
    Date Received
    May 27, 2016
    Date of Event
    April 27, 2016
    Report Date
    April 29, 2016
    Manufacturer
    LIVANOVA CANADA CORP.
    Product Code
    DYE
    PMA / PMN Number
    P060038/S026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LIVANOVA FOLLOWED UP TO OBTAIN MORE INFORMATION ON THE DEVICE, DETAILS ABOUT THE SURGERY AND RETURN OF THE DEVICE. IT WAS INDICATED DURING THE FOLLOW UP THAT DEVICE WILL NOT BE RETURNED AND NO ANALYSIS REPORT IS EXPECTED. DUE TO THE FACT THAT NO INFORMATION ABOUT THE SERIAL NUMBER OF THE DEVICE AND DEVICE IS NOT GOING TO BE RETURNED FOR ANALYSIS, IT IS NOT POSSIBLE TO PERFORM DEVICE HISTORY RECORD REVIEW AND ANY INVESTIGATION OF THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    NARRATIVE: THE COMPLETE MANUFACTURING AND MATERIAL RECORDS FOR THE CROWN PRT AORTIC PERICARDIAL HEART VALVE, CNA23(SN# (B)(4)), WERE PULLED AND REVIEWED BY QUALITY CONTROL AT LIVANOVA (B)(4) CORP. THE RESULTS CONFIRMED THAT EACH MANUFACTURING AND INSPECTION OPERATIONS WERE FOLLOWED AND THIS VALVE SATISFIED ALL MATERIAL, VISUAL, AND PERFORMANCE STANDARDS REQUIRED FOR A CROWN PRT AORTIC PERICARDIAL HEART VALVE AT THE TIME OF MANUFACTURE AND RELEASE. PRE-SHIPMENT FUNCTION TEST VIDEO WAS REVIEWED TO QUALITATIVELY EVALUATE VALVE IN 4 PHASES: CLOSED, OPENING, OPEN AND CLOSING. VIDEO SHOWED SYNCHRONOUS OPENING AND CLOSING WITH SMOOTH, CONTINUOUS MOTION AND NO LEAFLET FLUTTERING. MEETS ALL FUNCTION TEST CRITERIA OBSERVABLE ON VIDEO FOR A SIZE 23 MODEL CNA. THE VALVE PERFORMED AS EXPECTED AND MET ALL FUNCTION TEST QUALITY CONTROL CRITERIA THAT CAN BE OBSERVED DURING VIDEO PLAYBACK. NO STENT DEFORMATION WAS OBSERVED IN THE REVIEW OF THE RECORD AT THE TIME OF RELEASE OF THE CROWN PRT VALVE. CORRECTIONS: OUTCOMES ATTRIBUTED TO ADVERSE EVENTS, TYPE OF REPORTABLE EVENTS, DATE RECEIVED BY MFR, EVALUATION CODES, SEX. ADDITIONAL INFORMATION: DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    THE MANUFACTURER WAS NOTIFIED ON 29 APRIL 2016 THAT A CROWN VALVE IMPLANTED ON (B)(6) 2016 SHOWED STENO- INSUFFICIENCY WITH HIGH GRADIENT. THE VALVE WAS THEN EXPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: ON JULY 15, 2016, MANUFACTURER WAS NOTIFIED THAT THE CROWN VALVE DID NOT OPEN PROPERLY AND STENT SEEMS NOT TO BE STRAIGHT ANYMORE AFTER THE IMPLANTATION AND WAS CURVED TO THE MIDDLE. CROWN VALVE WAS EXPLANTED. PATIENT WAS IMPLANTED WITH PERIMOUNT VALVE. AFTERWARDS, PATIENT HAD A MYOCARDIAL INFARCTION AND PATIENT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340955 CROWN PRT PERICARDIAL HEART VALVE TISSUE HEART VALVE DYE LIVANOVA CANADA CORP. CNA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R