BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLACEMENT HEART VALVE

    MDR report key: 6749536 · Received July 27, 2017

    Report

    Report Number
    2015691-2017-02259
    Event Type
    Injury
    Date Received
    July 27, 2017
    Date of Event
    March 1, 2014
    Report Date
    July 6, 2017
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PARAVALVULAR LEAK (PVL) REFERS TO BLOOD FLOWING THROUGH A CHANNEL BETWEEN THE STRUCTURE OF THE IMPLANTED VALVE AND THE CARDIAC TISSUE. IT MAY OCCUR AS A RESULT OF A LACK OF APPROPRIATE SEALING OF THE VALVE AT THE ANNULUS. THE MOST COMMON REASON FOR PVL IS INADEQUATE DEBRIDEMENT OF A CALCIFIED ANNULUS AND IS NOT A RESULT OF DEVICE MALFUNCTION. THERE MAY BE SMALL PVLS IDENTIFIED INTRA-OPERATIVELY OR POST-OPERATIVELY WHICH DO NOT REQUIRE ANY INTERVENTION. MOST CASES OF PVL NOTED INTRA-OPERATIVELY ARE CORRECTED WITH STANDARD SURGICAL TECHNIQUES DURING THE INITIAL IMPLANT PROCEDURE AND DO NOT LEAD TO SERIOUS INJURY OR DEATH. IN THIS CASE, THE PATIENT IS REPORTEDLY BEING ASSESSED FOR INTERVENTION TO CORRECT A WORSENING PVL (FROM 1 TO 2). HOWEVER, THERE IS NO INFORMATION MADE AVAILABLE REGARDING THE PATIENT'S CONDITION OR COMORBIDITIES NOR IS THERE INFORMATION REGARDING THE CONDITION OF THE DEVICE THAT WOULD ASSIST IN DETERMINE ROOT CAUSE FOR THIS PROGRESSION OF PVL. THE DEVICE IS NOT AVAILABLE FOR RETURN AND EVALUATION BECAUSE IT REMAINS IMPLANTED IN THE PATIENT. NO DEVICE HISTORY RECORD (DHR) REVIEW CAN BE DONE WITHOUT THE SERIAL NUMBER OF THE DEVICE. NO FURTHER CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED WITH THE AVAILABLE INFORMATION. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL EVENTS THROUGH THE USE OF EDWARDS QUALITY SYSTEMS. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    THROUGH REVIEW OF ARTICLE "RAPID-DEPLOYMENT AORTIC VALVE REPLACEMENT VERSUS STANDARD BIOPROSTHESIS IMPLANTATION", AUTHORS ENRICO FERRARI ET AL, EDWARDS LEARNT OF THE FOLLOWING COMPARATIVE ANALYSIS: METHODS: BETWEEN MARCH 2014 AND MAY 2015, 32 PATIENTS UNDERWENT AORTIC VALVE REPLACEMENT WITH THE INTUITY VALVE (INTUITY-GROUP). THESE PATIENTS WERE COMPARED TO A MATCHED POPULATION OF PERIMOUNT VALVES IMPLANTED DURING THE SAME PERIOD OF TIME (PERIMOUNT-GROUP). CLINICAL DATA WERE COMPARED AND ECHOCARDIOGRAPHIC 1-YEAR FOLLOW-UP WAS PERFORMED OBJECTIVE: TO COMPARE THE OUTCOME AND THE 1-YEAR HEMODYNAMIC RESULTS OF THE RAPID DEPLOYMENT INTUITY VALVE VERSUS THE PERIMOUNT MAGNA BIOPROSTHESIS IN MATCHED POPULATIONS WITHIN THE CONTEXT OF THIS ARTICLE, THE FOLLOWING EVENTS WERE IDENTIFIED AS PERTAINING TO AN EDWARDS DEVICE: 2 CASES OF PVL IN THE INTUITY VALVES GROUP (1 PVL GRADE 3. PLANS WERE BEING MADE FOR REINTERVENTION TO TREAT THE ISSUE + 1 PVL GRADE 1 WHICH PROGRESSED TO 2+ AT 1 ONE YEAR FOLLOW-UP. THIS PATIENT WAS REPORTED AS TO BE ASYMPTOMATIC ) THE RAPID DEPLOYMENT INTUITY VALVE CAN BE RELEASED SAFELY AND EFFICACIOUSLY AT FIRST ATTEMPT WITH A LOW RATE OF COMPLICATIONS AND PACEMAKER IMPLANTATION. CROSS-CLAMP AND CARDIOPULMONARY BYPASS TIMES CAN BE REDUCED, ESPECIALLY IN COMBINED PROCEDURES. PARAVALVULAR LEAKS AFTER INTUITY VALVE IMPLANTATION MUST BE ADDRESSED AT THE TIME OF SURGERY TO AVOID THE NEED FOR EARLY VALVE REINTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528490 REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES

    Patients

    Seq Age Sex Outcome Treatment
    1