BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 2922433 · Received January 18, 2013

    Report

    Report Number
    2015691-2013-19136
    Event Type
    Injury
    Date Received
    January 18, 2013
    Date of Event
    December 21, 2012
    Report Date
    December 21, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P100041
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS IT REMAINS IMPLANTED IN THE PATIENT; HOWEVER, THERE IS NO ALLEGATION OF DEVICE MALFUNCTION. PER THE INSTRUCTIONS FOR USE (IFU), PARAVALVULAR LEAK AND ARRHYTHMIAS ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH BIOPROSTHETIC HEART VALVE AND THE TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. THE EDWARDS SAPIEN RETROFLEX 3 TRANSFEMORAL DELIVERY SYSTEM TRAINING GUIDE INSTRUCTS THE OPERATOR ON PROPER POSITIONING AND DEPLOYMENT OF THE VALVE, INCLUDING ALL PROCEDURAL AND ANATOMICAL CONSIDERATIONS. IN ADDITION, THE PATIENT SCREENING MANUAL AND THE PROCEDURE DIDACTIC IDENTIFY SEVERAL PROCEDURAL AND ANATOMICAL FACTORS WHICH COULD CONTRIBUTE TO PARAVALVULAR LEAK, INCLUDING DEVICE MALPOSITIONING, INACCURATE MEASUREMENT OF THE NATIVE VALVE ANNULUS, IMPROPER VALVE SIZING, AND UNEVEN DISTRIBUTION OF CALCIUM ON THE NATIVE VALVE. DURING TAVR, VENTRICULAR FIBRILLATION (VF) IS TYPICALLY A COMPLICATION ASSOCIATED WITH POOR VENTRICULAR FUNCTION, ANNULAR RUPTURE/ AORTIC DISSECTION, AND/OR INADEQUATE CORONARY PERFUSION. THE THV TRAINING GUIDE CAUTIONS THAT VF CAN OCCUR DURING RAPID VENTRICULAR PACING (RVP) AND TO MINIMIZE MYOCARDIAL ISCHEMIA ADVISES THE OPERATOR TO ENSURE THAT THE PATIENT'S SYSTOLIC BLOOD PRESSURE IS MAINTAINED ABOVE 100MMHG BEFORE RVP. IN THIS CASE, DUE TO INADEQUATE VASCULAR ACCESS, A TOO SMALL VALVE WAS IMPLANTED FOR THE DIAMETER OF THE PATIENT'S NATIVE ANNULUS (23 MM VALVE INSTEAD OF A 26MM VALVE). PER THE IFU AND THV TRAINING MANUALS, THE 23MM SAPIEN VALVE IS INDICATED FOR NATIVE ANNULAR DIAMETERS BETWEEN 18-22MM, AND THE 26MM VALVE IS INDICATED FOR NATIVE ANNULAR DIAMETERS BETWEEN 21-25MM. IN ADDITION, THE PATIENT HAD SEVERE, BULKY CALCIFICATION OF THE NATIVE AORTIC VALVE, WHICH COULD HAVE CONTRIBUTED TO THE PVL. THE VENTRICULAR FIBRILLATION WAS LIKELY DUE TO A COMBINATION OF RVP IN A PATIENT WITH UNDERLYING CAD, ISCHEMIC CARDIOMYOPATHY, POOR VENTRICULAR FUNCTION (EF OF 10%), AND INTRA-PROCEDURAL MODERATE-SEVERE PVL POST VALVE DEPLOYMENT. PER THE IFU, THE BIOPROSTHESIS IS CONTRAINDICATED IN PATIENTS WITH SEVERE VENTRICULAR DYSFUNCTION WITH EJECTION FRACTION <20%. THE IFU AND TRAINING MANUALS HAVE BEEN REVIEWED AND NO INADEQUACIES HAVE BEEN IDENTIFIED WITH REGARDS TO WARNINGS, CONTRAINDICATIONS, AND THE DIRECTIONS/CONDITIONS FOR THE SUCCESSFUL USE OF THE DEVICE. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS ON A MONTHLY BASIS, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS MONTHLY REVIEW. NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    AS REPORTED BY THE EDWARDS FIELD CLINICAL SPECIALIST, MODERATE/SEVERE PARAVALVULAR LEAK (PVL) WAS NOTED POST DEPLOYMENT OF THE 23MM SAPIEN VALVE. THE PVL WAS REDUCED BY THE IMPLANTATION OF TWO AMPLATZER VASCULAR PLUGS. BY TEE, THE ANNULUS WAS 25MM WITH SEVERE, BULKY CALCIFICATION. FEMORAL ARTERY ACCESS WAS GAINED AND SERIAL DILATION WAS PERFORMED; HOWEVER, THE 28F DILATOR WOULD NOT PASS INTO THE DISTAL AORTA AND THE 24F SHEATH WAS ATTEMPTED UNSUCCESSFULLY. THE DECISION WAS MADE TO PLACE THE 22F SHEATH AND IMPLANT A 23MM VALVE. BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED WITH A 20X3 BALLOON. THE SAPIEN VALVE WAS PREPPED WITH 19CC'S, POSITIONED, AND DEPLOYED UNDER RAPID VENTRICULAR PACING (RVP). POST VALVE DEPLOYMENT THE PATIENT'S SYSTOLIC PRESSURE WAS LOW. CPR WAS STARTED AND EPI WAS ADMINISTERED WITH RAPID EFFECTS. MODERATE/SEVERE PVL WAS NOTED ON TEE, SO POST DILATATION WAS PERFORMED WITH 1CC ADDED TO THE DELIVERY BALLOON. AFTER POST DILATATION THE PATIENT DEVELOPED VENTRICULAR TACHYCARDIA (VT). THE PATIENT WAS DEFIBRILLATED AND EPI WAS ADMINISTERED FOR LOW BLOOD PRESSURE. THE PVL WAS CROSSED WITH A WIRE AND A CORONARY BALLOON WAS PLACED ACROSS. BY TEE THE LEAK APPEARED TO BE CRESCENT SHAPED. TWO AMPLATZER VASCULAR PLUGS WERE PLACED IN THE AREA OF THE PVL. THE PVL APPEARED TO HAVE BEEN REDUCED ON THE FINAL TEE. THE VALVE WAS EXAMINED AT UNDER CINE/FLUOROSCOPY AND APPEARED TO BE FUNCTIONING WELL. ADDITIONAL INVESTIGATION REVEALED THE FOLLOWING: THE NATIVE AORTIC VALVE WAS SEVERELY CALCIFIED WITH THE CALCIUM DISTRIBUTED IN BULKY CHUNKS. THE AORTIC ROOT WAS ALSO SEVERELY CALCIFIED. A PREEXISTING PROSTHETIC VALVE WAS PRESENT IN THE MITRAL POSITION. THE PATIENT'S EJECTION FRACTION (EF) WAS 10%. THE SAPIEN VALVE WAS POSITIONED AND DEPLOYED IN 60:40 AORTIC POSITION. THE COAXIAL ALIGNMENT OF THE VALVE AND DELIVERY SYSTEM WAS DESCRIBED AS POOR, AND THE IMAGE INTENSIFIER ANGLE WAS DESCRIBED AS FAIR. PER REPORT, THE PERCEIVED CAUSE OF THE PVL WAS THAT THE 23MM SAPIEN VALVE WAS TOO SMALL FOR THE NATIVE ANNULUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28459 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX23A 3053113

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention