BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 3160212 · Received June 10, 2013

    Report

    Report Number
    2015691-2013-20301
    Event Type
    Injury
    Date Received
    June 10, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 14, 2013
    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 EDWARDS SAPIEN TRANSCATHETER HEART VALVE IS INDICATED FOR TRANSFEMORAL DELIVERY IN PATIENTS WITH SEVERE SYMPTOMATIC CALCIFIED NATIVE AORTIC VALVE STENOSIS WITHOUT SEVERE AORTIC INSUFFICIENCY. PER THE INSTRUCTIONS FOR USE, DEVICE EMBOLIZATION IS A KNOWN POTENTIAL ADVERSE EVENT 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 AORTIC EMBOLIZATION, INCLUDING IMPROPER POSITIONING PRIOR TO DEPLOYMENT, POOR IMAGE INTENSIFIER ANGLE, POOR COAXIAL ALIGNMENT OF THE VALVE AND DELIVERY SYSTEM, SEVERE SEPTAL HYPERTROPHY, MINIMALLY CALCIFIED AORTIC LEAFLETS, PRESERVED EJECTION FRACTION, AND LOSS OF PACING CAPTURE. 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 AORTIC EMBOLIZATION (I.E. MINIMAL LEAFLET CALCIFICATION, SEVERE SEPTAL HYPERTROPHY), 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, PRE-PROCEDURAL IMAGING CONFIRMED THE PATIENT DID NOT HAVE SUFFICIENT AORTIC CALCIFICATION TO IMPLANT AND ANCHOR THE SAPIEN VALVE TO THE ANNULUS. HOWEVER, AS THERE WERE NO OTHER MEDICAL OPTIONS, THE MEDICAL TEAM DETERMINED THAT THE POSSIBLE BENEFITS TO THE PATIENT OUTWEIGHED THE RISK AND THE TAVR PROCEDURE WAS ATTEMPTED IN AN OFF-LABEL MANNER. 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 (B)(4) BASIS, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS (B)(4)Y REVIEW. NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    AS REPORTED BY THE EDWARDS FIELD CLINICAL SPECIALIST, DURING A TRANSFEMORAL TAVR CASE THE 26 MM SAPIEN VALVE EMBOLIZED INTO THE AORTA. THE RETROFLEX 3 BALLOON WAS INFLATED WITHIN THE VALVE AND THE VALVE WAS PULLED AROUND THE AORTIC ARCH INTO THE DESCENDING AORTA. THE VALVE CAME TO REST DISTAL TO THE LEFT SUBCLAVIAN. THE BALLOON WAS EXPANDED FURTHER AND THE VALVE WAS CONFIRMED TO BE ANCHORED INTO THE THORACIC AORTA. TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) EVALUATION SHOWED GOOD AORTIC WALL APPOSITION AND THE LEAFLETS REMAINED IN THE OPEN POSITION. THERE WAS DISCUSSION ABOUT GOING IN WITH A SECOND VALVE AND REATTEMPTING VALVE DEPLOYMENT, BUT IT WAS DECIDED NOT TO DO THIS. THE WIRE AND THE SHEATH WERE REMOVED, FEMORAL ACCESS WAS CLOSED AND CASE WAS COMPLETED. THIS EVENT WAS ATTRIBUTED TO THE PATIENT¿S LACK OF AORTIC CALCIFICATION. THE IMPLANT TEAM WAS AWARE OF THIS RISK PRIOR TO THE CASE AND WAS PREPARED TO DEAL WITH THIS LIKELY SCENARIO. THEY PROCEEDED WITH THE CASE BECAUSE THEY FELT THAT THE PATIENT DID NOT HAVE ANY OTHER OPTIONS. PER REPORT, ONE WEEK PRIOR TO THE CASE, ECHO AND CT IMAGES WERE REVIEWED WITH THE TEAM AND IT WAS DETERMINED THAT THIS PATIENT WAS NOT A GOOD CANDIDATE FOR A SAPIEN VALVE DUE TO LACK OF CALCIFICATION. PRIOR TO VALVE DEPLOYMENT A PLANNED CORONARY INTERVENTION WAS PERFORMED, A FOCAL RIGHT CORONARY ARTERY LESION WAS STENTED AS WELL AS A FOCAL LESION AT THE 2ND OBTUSE MARGINAL. INITIALLY THE TAVR PROCEEDED UNEVENTFULLY. THE SHEATH WAS INSERTED, COAXIAL ANGLE WAS OBTAINED, THE VALVE WAS CROSSED AND THE STIFF WIRE WAS POSITIONED IN THE LEFT VENTRICLE. THE 26 MM SAPIEN VALVE WAS POSITIONED ACROSS THE ANNULUS AND DEPLOYED UNDER RAPID VENTRICULAR PACING. ALMOST IMMEDIATELY THE VALVE MOVED AORTIC AND CAME TO REST IN THE ASCENDING AORTA. THE PATIENT REMAINED HEMODYNAMICALLY STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260223 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX26 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention