BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT® PLUS PERICARDIAL BIOPROSTHESIS

    MDR report key: 4090515 · Received September 15, 2014

    Report

    Report Number
    2015691-2014-02156
    Event Type
    Injury
    Date Received
    September 15, 2014
    Date of Event
    July 14, 2014
    Report Date
    August 19, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO EDWARDS FOR ANALYSIS. DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. REGURGITATION IS CONSIDERED TO BE A PERIVALVULAR LEAK (PVL) IF A TURBULENT ECCENTRIC JET ORIGINATES BETWEEN THE BIOPROSTHETIC SEWING RING AND THE ANNULUS. WHILE THE MAJORITY OF AFFECTED PATIENTS ARE ASYMPTOMATIC, PVL, WHEN SEVERE, CAN LEAD TO SIGNIFICANT MORBIDITY INCLUDING HEART FAILURE AND HEMOLYTIC ANEMIA. PVL CAN OCCUR IN THE MITRAL AND AORTIC POSITION FOR SIMILAR REASONS, INCLUDING TECHNIQUE AND PATIENT RELATED FACTORS. EDWARDS IS UNABLE TO CONFIRM THE CLINICAL OBSERVATION. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL EVENTS. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    IN THIS CASE, A 25MM PERICARDIAL MITRAL VALVE, IMPLANTED APPROXIMATELY FOUR (4) DAYS, WAS EXPLANTED DUE TO PERIVALVULAR LEAK (PVL). ON THE DATE OF IMPLANT, POST OPERATIVE TEE REVEALED SOME PERIVALVULAR LEAKING AT THE POSTERIOR ANNULUS WHERE SEVERE CALCIFICATION HAD EXISTED. PATIENT SHOWED WORSENING PVL ON DAY THREE POST-IMPLANT IN THE AREA OF CALCIFICATION. AFTER REPLACEMENT IMPLANT OF 25MM PERICARDIAL VALVE, THERE WAS NO PVL AND SATISFACTORY HEMOSTASIS WAS ACHIEVED. PATIENT TOLERATED THE PROCEDURE WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569637 CARPENTIER-EDWARDS PERIMOUNT® PLUS PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 6900PTFX25

    Patients

    Seq Age Sex Outcome Treatment
    1 82 Required Intervention