BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 2968005 · Received February 19, 2013

    Report

    Report Number
    2015691-2013-19326
    Event Type
    Injury
    Date Received
    February 19, 2013
    Date of Event
    October 22, 2012
    Report Date
    January 22, 2013
    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 INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INVESTIGATION REVEALED THE FOLLOWING: PER THE IMPLANTING PHYSICIAN, THE AORTIC REGURGITATION WAS CLEARLY A PARAVALVULAR LEAK (NOT A CENTRAL LEAK AS INITIALLY REPORTED), LIKELY RELATED TO BULKY CALCIUM ON THE NATIVE LEAFLETS. THERE WERE NO OBVIOUS STRUCTURAL PROBLEMS WITH THE SAPIEN VALVE. DURING THE TAVR PROCEDURE, THE NATIVE ANNULAR DIAMETER WAS BETWEEN 20-21.3MM ON TEE, DENSE CALCIUM WAS NOTED ON THE NATIVE AORTIC VALVE, AND MITRAL ANNULAR CALCIFICATION (MAC) WAS NOTED. THE PATIENT HAD A PRESERVED EJECTION FRACTION (EF). POST VALVE DEPLOYMENT, THE SAPIEN VALVE WAS POSITIONED 70:30 TO 80:20 AORTIC. ON TEE PVL WAS NOTED TOWARDS THE ANTERIOR LEAFLETS, ONE JET OF PVL ON EACH SIDE. A POST DILATATION WAS PERFORMED WITH 1CC ADDED TO THE DELIVERY SYSTEM, WHICH YIELDED A FINAL RESULT OF MILD PVL AT THE COMMISURE. POST PROCEDURE, THE PATIENT DEVELOPED MODERATE TO SEVERE PVL WITH HEMODYNAMIC COMPROMISE, SO A SURGICAL VALVE WAS IMPLANTED. THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS IT REMAINS IMPLANTED IN THE PATIENT. PER THE INSTRUCTIONS FOR USE, DEVICE MALPOSITION REQUIRING INTERVENTION AND VALVE REGURGITATION ARE POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. THERE ARE SEVERAL PATIENT AND PROCEDURAL FACTORS THAT ALONE OR IN COMBINATION CAN CAUSE OR CONTRIBUTE TO AORTIC MALPOSITION, INCLUDING IMPROPER POSITIONING PRIOR TO DEPLOYMENT, POOR IMAGE INTENSIFIER ANGLE, POOR COAXIAL ALIGNMENT OF THE VALVE/DELIVERY SYSTEM, SEVERE SEPTAL HYPERTROPHY, MINIMAL VALVE CALCIFICATION, AND LOSS OF PACING CAPTURE. THE PROCEDURAL DIDACTIC INSTRUCTS THE OPERATOR ON PROPER POSITIONING AND DEPLOYMENT OF THE VALVE, INCLUDING ALL PROCEDURAL AND ANATOMICAL CONSIDERATIONS. PHYSICIANS ARE EXTENSIVELY TRAINED BY EDWARDS BEFORE THEY ARE QUALIFIED TO USE THE TRANSCATHETER HEART VALVE (THV). TRAINING INCLUDES DEVICE PREPARATION, APPROACH, DEPLOYMENT, IMAGING, PROCEDURE-SPECIFIC TRAINING MANUALS AND PROCTORED PROCEDURES. THE CORRECT ALIGNMENT AND POSITIONING OF THE DEVICE AT THE POINT OF DEPLOYMENT IS EMPHASIZED AS A KEY FACTOR TO THE PLACEMENT AND FIXATION OF THE DEVICE. 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. IN THIS CASE, PER THE IMPLANTING PHYSICIAN, THE PVL WAS LIKELY RELATED TO BULKY CALCIFICATION ON THE NATIVE LEAFLETS. NO STRUCTURAL PROBLEMS WERE NOTED WITH THE SAPIEN VALVE. IN ADDITION, THE 70:30 TO 80:20 AORTIC POSITIONING OF THE SAPIEN VALVE MAY HAVE ALSO CONTRIBUTED TO THE EVENT. ALTHOUGH THE ROOT CAUSE OF THE AORTIC MALPOSITION CANNOT BE CONFIRMED, A COMBINATION OF PATIENT FACTORS (BULKY NATIVE LEAFLET CALCIFICATION, MAC AND A PRESERVED EF) MAY HAVE CONTRIBUTED.

    Description of Event or Problem · 1

    THE EDWARDS IMPLANT PATIENT REGISTRY (IPR) DEPARTMENT WAS NOTIFIED THAT THE SAPIEN VALVE WAS EXPLANTED 41 DAYS POST TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR). A SURGICAL HEART VALVE WAS IMPLANTED. UPON INVESTIGATION, IT WAS LEARNED THAT THE VALVE WAS EXPLANTED DUE TO MODERATE TO SEVERE CENTRAL AORTIC INSUFFICIENCY (CAI).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72096 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX23

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention