BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN XT TRANSCATHETER HEARRT VALVE, 26MM

    MDR report key: 3951300 · Received July 22, 2014

    Report

    Report Number
    2015691-2014-01654
    Event Type
    Injury
    Date Received
    July 22, 2014
    Date of Event
    July 7, 2014
    Report Date
    July 7, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P130009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE INSTRUCTIONS FOR USE, VALVE REGURGITATION IS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH BIOPROSTHETIC HEART VALVES AND THE TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. THERE ARE MULTIPLE PATIENT AND PROCEDURAL FACTORS THAT ALONE OR IN COMBINATION CAN CAUSE OR CONTRIBUTE TO VALVE REGURGITATION INCLUDING MALPOSITION OF THE VALVE, IMPINGEMENT OF A LEAFLET DUE TO THE GUIDE WIRE, OVER INFLATION OF THE DEPLOYMENT BALLOON, POST DILATION OF THE IMPLANTED VALVE, AND SLOW RECOVERY OF ADEQUATE VENTRICULAR FLOW POST VALVE DEPLOYMENT AND RAPID PACING. ALL OF THESE FACTORS HAVE THE POTENTIAL TO CONTRIBUTE TO SUBOPTIMAL COAPTATION OF THE SAPIEN VALVE LEAFLETS AND CAUSE CENTRAL AORTIC INSUFFICIENCY. OCCASIONALLY THERE ARE CASES WHERE THE ROOT CAUSE OF THE REGURGITATION CANNOT BE DETERMINED. THE THV TRAINING MANUALS INSTRUCT THE OPERATOR ON PROPER POSITIONING AND DEPLOYMENT OF THE VALVE, INCLUDING ALL PROCEDURAL AND ANATOMICAL CONSIDERATIONS. THE PATIENT SCREENING MANUAL INSTRUCTS THE OPERATOR ON PROPER NATIVE VALVE LEAFLET ASSESSMENT, TAKING INTO CONSIDERATION THE LENGTH, BULKINESS AND DISTRIBUTION OF CALCIUM ON THE NATIVE LEAFLETS TO DETERMINE WHETHER VALVE PERFORMANCE WILL BE IMPAIRED. DURING THE MANUFACTURING PROCESS, ALL SAPIEN VALVES ARE 100% VISUALLY INSPECTED FOR DEFECTS AND 100% TESTED FOR COAPTATION PRIOR TO RELEASE FOR DISTRIBUTION. THIS MAKES IT HIGHLY UNLIKELY THAT A MANUFACTURING DEFECT OR DEVICE MALFUNCTION WOULD CONTRIBUTE TO THE EVENT. IN THIS CASE, THE VENTRICULAR TACHYCARDIA WAS ATTRIBUTED TO A ¿SICK VENTRICLE¿ AND THE CALCIUM DISTRIBUTION ON THE NATIVE VALVE WAS THOUGHT TO BE A CONTRIBUTOR TO THE INITIAL CENTRAL AI. 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.

    Description of Event or Problem · 1

    AFTER DEPLOYMENT OF A 26MM SAPIEN XT VALVE 50:50 AORTIC/VENTRICULAR TO THE NATIVE VALVE, THE PATIENT IMMEDIATELY WENT INTO VENTRICULAR TACHYCARDIA (VT), CPR WAS INITIATED AND THE PATIENT WAS PLACED ON PERIPHERAL BYPASS. ONCE THE PATIENT STABILIZED, TEE REVEALED SEVERE CENTRAL AORTIC INSUFFICIENCY (CAI) AND MILD TO MODERATE PARAVALVULAR (PVL). A BALLOON VALVULOPLASTY (BAV) WAS PERFORMED WITH A 26MM ZMED BALLOON WITH NO IMPROVEMENT. A SECOND VALVE WAS PLACED WITHIN THE FIRST VALVE, RESULTING IN MILD CAI AND MILD PVL. AS OF THE LAST REPORT, THE PATIENT WAS EXTUBATED AND SITTING UP IN BED. THE NATIVE AORTIC ANNULAR DIAMETER WAS 20MM X 30MM WITH AN AREA OF 510MM2 BY CT. PER REPORT, THERE WAS NO VENTRICULAR SEPTAL HYPERTROPHY AND NO MITRAL ANNULAR CALCIFICATION (MAC) AND THE EF WAS 30%. THE COAXIAL ALIGNMENT OF THE VALVE AND DELIVERY SYSTEM DURING DEPLOYMENT WAS REPORTED AS GOOD, AS WAS THE IMAGE INTENSIFIER ANGLE. THE NATIVE VALVE WAS SEVERELY CALCIFIED AND THE AORTIC ROOT WAS MILDLY CALCIFIED. DURING DEPLOYMENT VENTILATION WAS HELD AND PACING CAPTURE WAS NOT LOST. PER REPORT, IT WAS THOUGHT THAT A SHELF OF CALCIUM PREVENTED VALVE FROM COMPLETELY OPENING AND A "SICK VENTRICLE" MAY HAVE CAUSED THE VT. AS PER POST PROCEDURE DISCUSSION, IT COULD NOT BE DETERMINED IF THE 20 MINUTES OF CPR MAY HAVE ALSO CONTRIBUTED TO THE CAI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428635 EDWARDS SAPIEN XT TRANSCATHETER HEARRT VALVE, 26MM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9300TFX26

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention