BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS® PERIMOUNT MAGNA EASE¿ PERICARDIAL BIOPROSTHESIS

    MDR report key: 7601456 · Received June 14, 2018

    Report

    Report Number
    2015691-2018-02291
    Event Type
    Injury
    Date Received
    June 14, 2018
    Date of Event
    February 22, 2018
    Report Date
    May 23, 2018
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE WAS NOT RETURNED TO EDWARDS FOR EVALUATION AS IT REMAINS IMPLANTED. THE DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED AS A DEVICE SERIAL NUMBER WAS NOT PROVIDED. BIOPROSTHETIC TISSUE VALVES CAN DETERIORATE WITH TIME AND EVENTUALLY FAIL CONTRIBUTING TO REGURGITATION AND/OR STENOSIS. THERE CAN BE A NUMBER OF POTENTIAL KNOWN AND UNKNOWN PATIENT RELATED CONTRIBUTING FACTORS. STRUCTURAL VALVE DETERIORATION (SVD), A COMMON REASON FOR BIOPROSTHESIS EXPLANT OR REOPERATION, ENCOMPASSES MULTIPLE FAILURE MODES, INCLUDING CALCIFIC AND NON-CALCIFIC DEGENERATION, DEHISCENCE, CUSP THICKENING OR FIBROSIS, OR A COMBINATION OF THESE. SUCH FAILURE MODES, OCCURRING SINGULARLY OR CONCOMITANTLY, MAY CONTRIBUTE TO STENOSIS AND/OR REGURGITATION. ALTERNATIVELY, NONSTRUCTURAL DYSFUNCTION (NSVD) MAY ALSO PLAY A ROLE IN THE DEVELOPMENT OF VALVULAR STENOSIS. A MANUFACTURING RELATED ISSUE WAS NOT IDENTIFIED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED; HOWEVER, IT IS LIKELY THAT PATIENT RELATED FACTORS AND THE PROGRESSION OF THE UNDERLYING VALVULAR DISEASE PATHOLOGY CONTRIBUTED TO THE EVENT. EDWARDS LIFESCIENCES WILL CONTINUE TO MONITOR ALL REPORTED EVENTS. NO FURTHER ACTIONS ARE REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    ARTICLE "TRANSCAVAL VALVE-IN-VALVE-IN-VALVE AORTIC VALVE REPLACEMENT FOR BIOPROSTHETIC VALVE DEGENERATION," IN INNOVATIONS VOLUME 13, NUMBER 2, MARCH/APRIL 2018. ISSN: 1556-9845/18/1302-0132 PAGE 132-135. ABSTRACT: A (B)(6) MAN PRESENTED WITH PROGRESSIVE DYSPNEA ON EXERTION. HISTORY INCLUDED PERIPHERAL ARTERIAL DISEASE AND CORONARY ARTERY BYPASS GRAFTING WITH AORTIC VALVE REPLACEMENT 12 YEARS AGO. SUBSEQUENTLY, THE SURGICAL VALVE DEVELOPED SEVERE STENOSIS AND MODERATE INSUFFICIENCY. HE UNDERWENT A TRANSAPICAL VALVE-IN-VALVE TRANSCATHETER AORTIC VALVE REPLACEMENT 5 YEARS BEFORE PRESENTATION. THIS SECOND VALVE DEVELOPED A MEAN GRADIENT OF 66 MM HG WITH MILD INSUFFICIENCY. THE PATIENT WAS TREATED WITH A THIRD AORTIC VALVE USING AN ALTERNATIVE TRANSCAVAL APPROACH, SIGNIFICANTLY ALLEVIATING HIS SYMPTOMS. IN THIS CASE, MALE PATIENT WITH A 23MM VALVE IMPLANTED FOR APPROXIMATELY SEVEN YEARS UNDERWENT VALVE-IN-VALVE PROCEDURE WITH A 23MM TRANSCATHETER VALVE DUE TO SEVERE STENOSIS AND MODERATE INSUFFICIENCY. THIS MALE PATIENT HAS A HISTORY OF SEVERE CHRONIC OBSTRUCTIVE PULMONARY DISEASE, STEROID USE, DIABETES, STROKE, GASTROINTESTINAL BLEEDING, CORONARY ARTERY BYPASS GRAFTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445044 CARPENTIER-EDWARDS® PERIMOUNT MAGNA EASE¿ PERICARDIAL BIOPROSTHESIS HEART-VALVE, REPLACEMENT DYE EDWARDS LIFESCIENCES 3300TFX

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention