BEUDAMED
    FDA Adverse Event Death Summary report: N

    SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 2912170 · Received January 11, 2013

    Report

    Report Number
    2015691-2013-19088
    Event Type
    Death
    Date Received
    January 11, 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
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION TO THE SERIAL NUMBER OF THE VALVE.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS IT WAS DISCARDED BY THE SITE. PER THE INSTRUCTIONS FOR USE (IFU), DEVICE MALPOSITION/EMBOLIZATION REQUIRING INTERVENTION 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/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, IT APPEARS THAT A COMBINATION OF PATIENT FACTORS AND PROCEDURAL FACTORS LIKELY CONTRIBUTED TO THE TOO VENTRICULAR POSITION OF THE VALVE AND SUBSEQUENT EMBOLIZATION. . THE PATIENT HAD A HORIZONTAL AORTA, AND THE COAXIAL ALIGNMENT OF THE SHEATH WAS FAIR. ON TEE THE NATIVE VALVE MEASURED 23MM, HOWEVER, BY CT WAS 22.4MM X28.7MM, INDICATING THAT THE LONG AXIS MEASUREMENT OF THE CT WAS POTENTIALLY LARGER THAN THE RECOMMENDED SIZE FOR A 26MM VALVE. IN THE SETTING OF MODERATE NATIVE VALVE/LEAFLET CALCIFICATION AND MILD AORTIC ROOT CALCIFICATION, THIS MAY HAVE CONTRIBUTED TO THE SEQUENCE OF EVENTS. 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 TRANSAPICAL TAVR PROCEDURE, A SAPIEN VALVE WAS POSITIONED 50:50 IN THE NATIVE ANNULUS, HOWEVER, POST DEPLOYMENT ENDED IN AN 80:20 VENTRICULAR POSITION. DURING DELIVERY OF SECOND SAPIEN VALVE, THE FIRST VALVE EMBOLIZED VENTRICULAR. MULTIPLE ATTEMPTS WERE MADE TO RECAPTURE THE EMBOLIZED VALVE BUT WERE UNSUCCESSFUL. THE SECOND DELIVERY SYSTEM WAS USED TO SNARE THE FIRST VALVE AND THEN THE SYSTEM WAS ADVANCED INTO THE ANNULUS. THE SECOND VALVE WAS SUCCESSFULLY DEPLOYED, AND THE FIRST VALVE WAS IN THE LVOT, HOWEVER, WHEN THE DELIVERY SYSTEM WAS PULLED BACK, THE FIRST VALVE AGAIN EMBOLIZED INTO THE VENTRICLE. THE EMBOLIZED VALVE WAS THEN RETRIEVED THROUGH A VENTRICULAR CUTDOWN. THE APEX WAS SUCCESSFULLY CLOSED. ADDITIONAL INFORMATION REVEALED: FEMORAL ACCESS WAS FIRST OBTAINED A&V ON BOTH SIDES. PHYSICIANS OBTAINED AN EXCELLENT COPLANAR VIEW, THORACOTOMY WAS PERFORMED, AND PURSE STRINGS SUCCESSFULLY PLACED. ON TEE THE VALVE MEASURED 23MM, BY CT 22.4MM X28.7MM. THE NATIVE VALVE/LEAFLET CALCIFICATION WAS MODERATE AND AORTIC ROOT CALCIFICATION WAS MILD. THE VALVE WAS PREPPED, SHEATH PLACED, AND PACER TESTED. IT TOOK SEVERAL ATTEMPTS TO GET A GOOD PULSE WIDTH PRESSURE BUT EVENTUALLY THEY DID. THE PATIENT HAD A HORIZONTAL AORTA WHICH LEAD TO FAIR COAXIAL ALIGNMENT OF THE SHEATH; HOWEVER, ON FLUORO IT LOOKED LIKE THE VALVE WAS GOING TO LAND WELL. THEY THEN PROCEEDED WITH SUCCESSFULLY PERFORMING BAV. THE 26MM VALVE/DELIVERY SYSTEM WAS ADVANCED AND AFTER TEST INJECTIONS AND PACER TEST, THEY CONFIRMED POSITIONING WAS GOOD. THE VALVE WAS DEPLOYED, BUT DURING POST DEPLOYMENT ASSESSMENT IT WAS DETERMINED THAT THE VALVE WAS TOO VENTRICULAR. THEY PREPPED A SECOND VALVE AND AS THE VALVE WAS EXITING THE SHEATH, THE FIRST VALVE WAS SEEN TO HAVE EMBOLIZED INTO THE VENTRICLE. AT THIS TIME THE PATIENT WAS PUT ON PUMP. THEY ATTEMPTED TO REMOVE THE SECOND VALVE SYSTEM THROUGH THE SHEATH, WHICH WAS UNSUCCESSFUL. THEY ATTEMPTED TO PLACE A LONG 14FR SHEATH IN THE LFA WITH THE THOUGHT TO DELIVER A BAV BALLOON TO GRAB AND PULL THE EMBOLIZED VALVE INTO THE LVOT, BUT COULD NOT OBTAIN ACCESS DUE TO EXTREME TORTUOSITY OF THE VESSEL. THEY ULTIMATELY USED THE SECOND VALVE SYSTEM TO SNARE THE EMBOLIZED VALVE, AND WERE ABLE TO PULL IT INTO THE LVOT, AND DEPLOYED THE 2ND VALVE INTO THE ANNULUS. THE FIRST VALVE THEN EMBOLIZED INTO THE VENTRICLE AGAIN. THE 2ND VALVE APPEARED WELL POSITIONED AND VIA ECHO ASSESSMENT HAD NO PVL AND MILD CENTRAL AI. THE EMBOLIZED VALVE WAS REMOVED THROUGH A VENTRICULAR CUTDOWN. THE VENTRICLE WAS REPAIRED SUCCESSFULLY. AFTER THE APEX WAS SUCCESSFULLY CLOSED AND THEY BEGAN REMOVING THE PERIPHERAL SHEATHS, IT WAS NOTED THAT THE SECOND VALVE HAD EMBOLIZED INTO THE AORTA AND HAD FLIPPED. THE VALVE WAS SNARED BY A BAV BALLOON AND PULLED INTO THE AORTIC ARCH WHERE A STENT WAS DEPLOYED WITHIN THE VALVE. POST PROCEDURE AN IABP WAS PLACED, ALL OTHER LINES REMOVED, AND THE PATIENT WENT TO THE UNIT. NO PROSTHETIC VALVE REMAINED IN THE PATIENT'S NATIVE AORTIC VALVE. THE PATIENT LATER EXPIRED. ON DISCUSSION WITH THE CS, IT WAS INDICATED THAT THE SEQUENCE OF EVENTS RESULTING IN THE 2 VALVE EMBOLIZATIONS MAY HAVE BEEN RELATED TO THE BORDERLINE SIZE OF THE VALVE/ OUTER EDGE OF THE SIZE ANNULUS FOR A 26MM VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16418 SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX26

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Death