BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CROWN PRT PERICARDIAL HEART VALVE

    MDR report key: 7579237 · Received June 7, 2018

    Report

    Report Number
    3004478276-2018-00212
    Event Type
    Injury
    Date Received
    June 7, 2018
    Date of Event
    May 11, 2018
    Report Date
    August 7, 2018
    Manufacturer
    LIVANOVA CANADA CORP
    Product Code
    LWR
    PMA / PMN Number
    P060038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER RECEIVED CONFIRMATION THAT THE SERIAL NUMBER OF THE DEVICE IS NOT AVAILABLE. AS SUCH, THE DEVICE MANUFACTURING RECORDS COULD NOT BE REVIEWED. GIVEN THE PATIENTS CLINICAL HISTORY (DIABETES, HYPERTENSION), IT IS LIKELY THAT THE PATIENTS SPECIFIC CLINICAL CONDITION CONTRIBUTED TO THE REPORTED EVENT. HOWEVER, AS THE DEVICE WAS NOT RECEIVED FOR ANALYSIS, NO DEVICE INVESTIGATION COULD BE PERFORMED AND THE ROOT CAUSE OF THE EVENT CANNOT BE DETERMINED. STRUCTURAL VALVE DETERIORATION IS LISTED AMONG THE POTENTIAL ADVERSE EVENTS ASSOCIATED WITH CARDIAC VALVE REPLACEMENT IN THE PERCEVAL INSTRUCTIONS FOR USE. AS SUCH, IT IS A KNOWN, THE EVENT IS A KNOWN RISK ASSOCIATED WITH THE PROCEDURE.

    Additional Manufacturer Narrative · 0

    BASED ON THE CLINICAL INFORMATION PROVIDED, PATIENT-PROSTHESIS MISMATCH WAS EXCLUDED AS A POSSIBLE CONTRIBUTING FACTOR. GIVEN THE PATIENT'S CLINICAL HISTORY (DIABETES, HYPERTENSION), THE PATIENT WAS AT INCREASED RISK OF STRUCTURAL VALVE DETERIORATION. THESE RISK FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THIS MDR WAS ALREADY SUBMITTED JULY 10, 2018 AND RESUBMITTED DUE TO MISSING 3RD ACKNOWLEDGMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CROWN CNA23 WAS IMPLANTED IN (B)(6) 2015 DUE TO MODERATE AR AND MODERATE RV IMPAIRMENT WITH PULMONARY HYPERTENSION. THE PRE-OPERATIVE EJECTION FRACTION WAS 35%. HISTOPATHOLOGY OF THE AORTA REVEALED MYXOID CHANGE, WITH THE POSSIBILITY OF CONNECTIVE TISSUE DISORDER. THE PATIENT'S CORONARIES WERE NORMAL AT THE TIME OF IMPLANT. POSSIBLE AORTIC ROOT DILATION WAS IDENTIFIED IN 2015 (42 MM AT SINUS OF VALSALVA (MAX)) PRIOR TO IMPLANT. ECHOCARDIOGRAPHY IN 2018 SHOWED DEGENERATIVE THICKENING/CALCIFICATION OF THE AORTIC BIOPROSTHESIS, WITH SEVERE STENOSIS, SEVERE TRANSVALVULAR AR AND MODERATE+ CENTRAL LEAK. THE LV WAS REPORTEDLY DILATED, WITH PRESERVED SYSTOLIC FUNCTION, AND RESTRICTIVE FILLING. MILD-MODERATE RV IMPAIRMENT AND MODERATE PULMONARY HYPERTENSION WERE ALSO REPORTED. THE PATIENT REQUIRED ADMISSION TO THE HOSPITAL FOR OFF-LOADING WITH IV DIURETICS, AND UNDERWENT A TRANSCATHETER AORTIC VALVE REPLACEMENT ON (B)(6) 2018. AORTIC ROOT DILATION WAS MEASURED TO BY 44 MM. THE PATIENT WAS REPORTED TO HAVE DIET-CONTROLLED DIABETES.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER IS IN THE PROCESS OF FOLLOWING UP TO OBTAIN ADDITIONAL INFORMATION ABOUT THIS EVENT. SHOULD THIS INFORMATION, INCLUDING THE DEVICE SERIAL NUMBER, BE RECEIVED, APPROPRIATE INVESTIGATIVE ACTION WILL BE TAKEN. DEVICE STILL IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CROWN CNA23 WAS IMPLANTED IN 2015. ECHOCARDIOGRAPHY IN 2018 SHOWED DEGENERATED TISSUE, WITH STENOSED LEAFLETS AND SEVERE TRANSVALVULAR AR. THE PATIENT REQUIRED ADMISSION TO THE HOSPITAL FOR OFF-LOADING WITH IV DIURETICS, AND UNDERWENT A TRANSCATHETER AORTIC VALVE REPLACEMENT ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421787 CROWN PRT PERICARDIAL HEART VALVE TISSUE HEART VALVE LWR LIVANOVA CANADA CORP CNA23

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention