BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 3141122 · Received June 3, 2013

    Report

    Report Number
    2015691-2013-20226
    Event Type
    Injury
    Date Received
    June 3, 2013
    Date of Event
    May 10, 2013
    Report Date
    May 10, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE INSTRUCTIONS FOR USE (IFU), DEVICE MALPOSITION REQUIRING INTERVENTION IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH THE TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. THERE ARE MULTIPLE PATIENT AND PROCEDURAL FACTORS THAT ALONE OR IN COMBINATION CAN CAUSE OR CONTRIBUTE TO VENTRICULAR MALPOSITION, INCLUDING IMPROPER POSITIONING PRIOR TO DEPLOYMENT, POOR IMAGE INTENSIFIER ANGLE, POOR COAXIAL ALIGNMENT OF THE VALVE/DELIVERY SYSTEM, A NARROW, CALCIFIED SINOTUBULAR JUNCTION, MINIMALLY CALCIFIED AORTIC LEAFLETS, AND LOSS OF PACING CAPTURE. PARAVALVULAR LEAK CAN OCCUR AS A RESULT OF A LACK OF APPROPRIATE SEALING OF THE VALVE TO THE TARGET SITE WHICH CAN OCCUR DUE TO UNEVEN DISTRIBUTION OF CALCIUM. IN SOME CASES, PLACEMENT OF THE VALVE IN A TOO VENTRICULAR POSITION CAN CONTRIBUTE TO NATIVE LEAFLET OVERHANG AND CAUSE CENTRAL AORTIC INSUFFICIENCY. THE THV TRAINING MANUALS INSTRUCT 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 PATIENT SCREENING, 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. OPERATORS ARE ALSO INSTRUCTED TO USE FLUOROSCOPY AS THE PRIMARY METHOD OF VISUALIZATION FOR POSITIONING AND DEPLOYMENT. IN PATIENTS WITH HIGH-RISK ANATOMICAL FEATURES FOR VENTRICULAR MALPOSITION (I.E. SMALL, CALCIFIED STJ, MINIMAL LEAFLET CALCIFICATION), BAV MAY PROVIDE INDICATION OF POTENTIAL BALLOON MOVEMENT DURING VALVE DEPLOYMENT. IN THIS CASE, A COMBINATION OF PATIENT AND PROCEDURAL FACTORS LIKELY CAUSED OR CONTRIBUTED TO THE EVENT. PER REPORT, THE PATIENT WAS DESCRIBED AS HAVING SEVERE AORTIC STENOSIS THUS IT IS LIKELY THE NATIVE VALVE/LEAFLETS WERE SIGNIFICANTLY CALCIFIED. THE IMPLANT TEAM ALSO INDICATED THAT ALTHOUGH THE VALVE APPEARED TO BE POSITIONED WITHIN THE ANNULUS IT MIGHT HAVE BEEN ACTUALLY TOO LOW (TOO VENTRICULAR); THUS IT IS POSSIBLE THE IMAGE INTENSIFIER ANGLE DURING THE CASE WAS SUBOPTIMAL. 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

    AS REPORTED BY THE EDWARDS FIELD CLINICAL SPECIALIST, ONE DAY POST TRANSFEMORAL TAVR PROCEDURE TRANSTHORACIC ECHOCARDIOGRAM (TTE) SHOWED 3+ TO 4+ AORTIC INSUFFICIENCY. THE VALVE TEAM DECIDED TO IMPLANT ANOTHER 23MM SAPIEN VALVE VIA TRANSAPICAL APPROACH. THE SECOND VALVE WAS PLACED ACROSS THE FIRST VALVE. FOLLOWING DEPLOYMENT THE PARAVALVULAR AND CENTRAL LEAKS WERE REDUCED TO TRACE. THE PATIENT WAS TRANSFERRED TO THE UNIT FOR POST-OP MANAGEMENT. PER REPORT, AT THE END OF THE FIRST TAVR PROCEDURE THE INTRAOPERATIVE TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) SHOWED 1+ AORTIC INSUFFICIENCY. THE PRE-DEPLOYMENT POSITION OF THE FIRST VALVE WAS APPROXIMATELY 50:50 AND THE FINAL VALVE POSITION WAS 60:40 VENTRICULAR. THE DEGREE OF NATIVE VALVE/LEAFLET AND AORTIC ROOT CALCIFICATION WAS NOT AVAILABLE; HOWEVER THE PATIENT WAS DESCRIBED AS HAVING SEVERE AORTIC STENOSIS. COAXIAL ALIGNMENT OF THE DELIVERY SYSTEM AND THE VALVE WAS DESCRIBED AS GOOD; THE IMAGE INTENSIFIER ANGLE WAS ALSO APPROPRIATE; THERE WAS NO LOSS OF PACING CAPTURE DURING VALVE DEPLOYMENT AND VENTILATION WAS HELD. THE PERCEIVED ROOT CAUSE OF THIS EVENT WAS DISCUSSED BY THE IMPLANT TEAM AND IT WAS DETERMINED THAT ALTHOUGH THE FIRST VALVE WAS PLACED WITHIN THE ANNULUS, IT MIGHT HAVE BEEN PLACED TOO LOW (TOO VENTRICULAR).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243442 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX23

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention