BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 2905576 · Received January 9, 2013

    Report

    Report Number
    2015691-2013-19067
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    December 19, 2012
    Report Date
    December 19, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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), DEVICE MALPOSITION/EMBOLIZATION REQUIRING INTERVENTION IS A KNOWN POTENTIAL ADVERSE EVENT 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. IN THIS CASE IT WAS REPORTED THAT EXCESS TENSION ON THE WIRE CONTRIBUTED TO THE AORTIC MOVEMENT OF THE VALVE. THERE ARE NO OTHER OBVIOUS CAUSES FOR THE AORTIC MOVEMENT OF THE VALVE. 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 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 PER THE EDWARDS CLINICAL SPECIALIST (CS), DURING A TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE, DURING DEPLOYMENT THE VALVE MOVED 80:20 AORTIC. SUBSEQUENTLY A SECOND VALVE WAS DEPLOYED. ADDITIONAL INFORMATION REVEALED THE NATIVE VALVE/LEAFLET CALCIFICATION WAS MODERATE AND THE AORTIC ROOT CALCIFICATION WAS CONSIDERED MODERATE. THE IMAGE INTENSIFIER ANGLE WAS DESCRIBED AS GOOD, AND THE COAXIAL ALIGNMENT WAS DESCRIBED AS GOOD. THERE WAS NO SEVERE SEPTAL HYPERTROPHY. DURING SAPIEN VALVE DEPLOYMENT, VENTILATION WAS HELD, BALLOON INFLATION WAS HELD FOR THREE OR MORE SECONDS, AND PACING CAPTURE WAS NOT LOST. DURING THE SECOND 26MM VALVE WAS POSITIONED MORE VENTRICULAR RESULTING IN A SATISFACTORY FINAL RESULT. THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE. THE IMPLANTING TEAM STATED THAT THEY FELT, IN RETROSPECT, THAT THERE WAS EXCESS TENSION ON THE WIRE AND THIS RESULTED IN THE AORTIC MIGRATION OF THE VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10809 SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX26

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Required Intervention