BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 3102727 · Received May 9, 2013

    Report

    Report Number
    2015691-2013-20037
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 19, 2013
    Report Date
    April 19, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION AS IT WAS NOT EXPLANTED FROM THE PATIENT; HOWEVER, PER REPORT, THERE WAS NO DEVICE MALFUNCTION. A DEVICE HISTORY REVIEW (DHR) FOR THE VALVE WAS NOT COMPLETED/REQUIRED AS THERE WAS ALLEGATION OF A DEVICE MALFUNCTION. FURTHERMORE, ALL VALVES ARE 100% VISUALLY INSPECTED FOR DEFECTS AND 100% LEAK TESTED PRIOR TO TERMINATION. PER THE IFU, DEVICE MIGRATION OR MALPOSITION REQUIRING INTERVENTION IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE TAVR PROCEDURE. IN ADDITION, 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 BULKY NATIVE VALVE CALCIFICATION IN COMBINATION WITH THE REPORTED FAST INFLATION OF THE BALLOON LIKELY CAUSED OR CONTRIBUTED TO THE VALVE JUMPING AORTIC DURING DEPLOYMENT. 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. A COMPLAINT HISTORY FOR THIS TYPE OF EVENT IS 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 CLINICAL SPECIALIST (CS), DURING THE TRANSFEMORAL TAVR PROCEDURE, THE FIRST VALVE WAS PREPPED AND POSITIONED IN A 60:40 VENTRICULAR POSITION, HOWEVER, DURING DEPLOYMENT THE VALVE SHIFTED VENTRICULAR RESTING 80:20 WITHIN THE NATIVE ANNULUS RESULTING IN SEVERE AI. PER REPORT, THE VALVE WAS STABLE AND NO ROCKING WAS OBSERVED A SECOND VALVE WAS IMPLANTED ONE CELL MORE VENTRICULAR THAN THE FIRST VALVE WITH A FINAL RESULT OF NO AORTIC REGURGITATION. THE PATIENT WAS NOTED TO BE IN STABLE CONDITION AT THE END OF THE PROCEDURE. ADDITIONAL INFORMATION PROVIDED BY THE CLINICAL SPECIALIST (CS), INDICATED THE PATIENT'S EJECTION FRACTION WAS 60% AND THE AORTIC VALVE WAS SEVERELY (BULKY) CALCIFIED. ADDITIONALLY, THE IMAGE INTENSIFIER ANGLE AND COAXIAL ALIGNMENT WERE NOTED TO BE GOOD, VENTILATION WAS HELD DURING DEPLOYMENT, AND THERE WAS NO LOSS OF PACING CAPTURE DURING VALVE DEPLOYMENT. IT WAS NOTED THAT THE FAST INFLATION OF THE VALVE DURING DEPLOYMENT CAUSED THE VALVE TO "JUMP" AORTIC DURING DEPLOYMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204293 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX23 59372141

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention