BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 2871300 · Received December 13, 2012

    Report

    Report Number
    2015691-2012-18834
    Event Type
    Injury
    Date Received
    December 13, 2012
    Date of Event
    November 14, 2012
    Report Date
    November 14, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS IN PROCESS.

    Additional Manufacturer Narrative · 1

    FOR THE REPORTED ANNULAR RUPTURE EVENT, CINE IMAGES WERE SUBMITTED FOR REVIEW BY EDWARDS LIFESCIENCES. NO ECHO IMAGERY WAS PROVIDED. OBSERVATIONS AND IMPRESSIONS WERE MADE BASED ON THE REVIEWED IMAGES. THE OBSERVATIONS OF THE CINE IMAGES SHOWED THAT THE PATIENT HAS SEVERE AORTIC VALVE CALCIFICATION, SEVERE AORTIC ROOT CALCIFICATION, NO PORCELAIN AORTA, AND NO MITRAL ANNULAR CALCIFICATION (MAC). THE FIRST VALVE WAS POSITIONED 60/40 AORTIC AND DEMONSTRATED AORTIC REGURGITATION (AR) WITHOUT CLEAR PRESENCE OF DYE EXTRAVASATION INDICATIVE OF ANNULAR RUPTURE. DURING DEPLOYMENT THERE WAS NO LOSS IN PACING CAPTURE, AND VENTILATION WAS HELD. THE BALLOON INFLATION SUSTAINED FOR GREATER THAN 3 SECONDS AND THE FINAL ROOT AORTOGRAM SUGGESTED THE PRESENCE OF THE AORTIC ROOT RUPTURE WITH DYE EXTRAVASATION. THE IMPRESSIONS FROM THE REVIEW SHOWED, THAT THERE WAS NO SIGNIFICANT VALVE OVERSIZING (23MM SAPIEN WAS IMPLANTED WITHIN A 22MM ANNULUS, MEASURED VIA ECHO). THERE IS A POSSIBILITY OF BULKY LEAFLET CALCIFICATION INVOLVING THE RIGHT AND NON CORONARY CUSPS. ACCORDING TO THE IFU, CARDIOVASCULAR INJURY, SUCH AS PERFORATION OR DAMAGE (DISSECTION) OF VESSELS, ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE TAVR PROCEDURE, BALLOON VALVULOPLASTY, AORTIC VALVE REPLACEMENT AND BIOPROSTHETIC HEART VALVES. ANNULAR/AORTIC RUPTURE IS TYPICALLY A COMBINATION OF FACTORS, INCLUDING ANATOMIC FACTORS (SEVERELY CALCIFIED AORTIC ROOT. OBLITERATED SINUSES OF VALSALVA [SOV]), AND PROCEDURAL FACTORS (SIGNIFICANT VALVE OVERSIZING (=4MM)). IN THIS CASE, IN ADDITION TO THE PROCEDURAL FACTORS, THE PATIENT FACTORS OF BULKY CALCIFIED LEAFLETS AND SEVERELY CALCIFIED AORTIC VALVE COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE PHYSICIANS UNDERGO EXTENSIVE TRAINING BY EDWARDS LIFESCIENCES IN ORDER TO PERFORM THV PROCEDURES. TRAINING INCLUDES DEVICE PREPARATION, APPROACH, POSITIONING AND DEPLOYMENT, IMAGING, TRAINING MANUALS AND PROCTORED PROCEDURES. THE PHYSICIAN'S TRAINING MANUALS INSTRUCT THE PHYSICIAN ON THE PROPER STEPS AND TECHNIQUES FOR SUCCESSFUL VALVE DEPLOYMENT. THE IFUS 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 EDWARDS DEVICES. 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 VIA THE EDWARDS CLINICAL SPECIALIST, DURING A TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE, POST DEPLOYMENT OF A SAPIEN VALVE, THE PATIENT'S BLOOD PRESSURE DROPPED AND AN ANGIOGRAM REVEALED AN ANNULAR RUPTURE. THE PATIENT WAS CONVERTED TO OPEN HEART SURGERY TO REPAIR THE RUPTURE. ACCORDING TO THE CASE SUMMARY, BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED SUCCESSFULLY WITH A NON-EDWARDS BALLOON. THE RETROFLEX3 DELIVERY SYSTEM WITH THE SAPIEN VALVE (23MM) WAS POSITIONED 50:50 ACROSS THE AORTIC VALVE ANNULUS. AFTER A SATISFACTORY DEPLOYMENT, IT WAS NOTICED THAT THE PATIENT'S BLOOD PRESSURE WAS DROPPING. INITIALLY, AN ANGIOGRAM OF THE AORTIC ROOT REVEALED MORE THAN MODERATE AORTIC INSUFFICIENCY. WHILE A 2ND SAPIEN VALVE WAS BEING RINSED, A SECOND ANGIOGRAM REVEALED AN ANNULAR RUPTURE THAT WAS CAUSING A CARDIAC TAMPONADE. A SURGICAL WINDOW WAS PREFORMED TO REDUCE THE BLOOD IN THE PERICARDIUM AND THE DECISION WAS MADE TO CONVERT THE PATIENT TO OPEN HEART REPAIR OF THE RUPTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX23 59067452, 59232127

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention