BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 3120936 · Received May 20, 2013

    Report

    Report Number
    2015691-2013-20137
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    April 24, 2013
    Report Date
    April 24, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE FOR ANALYSIS AS IT REMAINS IMPLANTED IN THE PATIENT; HOWEVER, THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. PER THE INSTRUCTIONS FOR USE, DEVICE MALPOSITION REQUIRING INTERVENTION AND VALVE REGURGITATION ARE KNOWN 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 OR 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 SAPIEN 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 THIS CASE THE ROOT CAUSE OF THE AORTIC MALPOSITION CANNOT BE DETERMINED; HOWEVER, PATIENT (SEVERE AORTIC VALVE CALCIFICATION, HORIZONTAL HEART, KYPHOSIS) AND PROCEDURAL FACTORS (POOR COAXIAL ALIGNMENT WITH DIFFICULTY ALIGNING THE VALVE, BORDERLINE TOO LARGE NATIVE ANNULUS FOR THE 26MM VALVE) LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. 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, DURING THE TRANSAORTIC TAVR PROCEDURE A 26MM SAPIEN VALVE WAS ALIGNED 50/50 IN THE NATIVE ANNULUS. REPORTEDLY THE PHYSICIAN EXPERIENCED DIFFICULTY ALIGNING THE VALVE DUE TO THE PATIENT¿S HORIZONTAL HEART AND ANGLE OF THE SHEATH. THE VALVE WAS DEPLOYED UNDER RVP; HOWEVER, THE POST DEPLOYMENT POSITION WAS CANTED 70 AORTIC/30 VENTRICULAR ON THE LEFT AND 90 AORTIC/10VENTRICULAR ON THE RIGHT. POST-DEPLOYMENT TEE SHOWED MODERATE PVL. THE PHYSICIANS DECIDED TO PLACE A SECOND VALVE. A SECOND VALVE WAS PREPARED AND DEPLOYED UNDER RVP, ONE CELL MORE VENTRICULAR THAN THE FIRST VALVE. POST-DEPLOYMENT TEE SHOWED MODERATE PVL; IT WAS DECIDED TO POST-DILATE, 1CC OF CONTRAST WAS ADDED TO THE DELIVERY SYSTEM AND POST-DILATION WAS PERFORMED. A SLIGHT IMPROVEMENT IN THE PVL WAS SEEN BUT WAS STILL GRADED AS MODERATE, NO CAI WAS NOTED. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER COMPLICATION AND THE PATIENT WAS TRANSFERRED TO CCU IN STABLE CONDITION. THE PATIENT¿S ANNULUS MEASURED 25MM ON TEE, THERE WAS SEVERE NATIVE VALVE / LEAFLET CALCIFICATION, NO ROOT CALCIFICATION, MILD MAC, NO SEPTAL HYPERTROPHY AND AN EF OF 60%. ADDITIONALLY IT WAS REPORTED THAT THERE WAS POOR COAXIAL ALIGNMENT OF THE DELIVERY SYSTEM AND VALVE, GOOD IMAGE INTENSIFIER ANGLE, VENTILATION WAS HELD AND THERE WAS NO LOSS OF PACING CAPTURE DURING VALVE DEPLOYMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222441 SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX26A

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention