BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 2974245 · Received February 22, 2013

    Report

    Report Number
    2015691-2013-19352
    Event Type
    Death
    Date Received
    February 22, 2013
    Date of Event
    January 31, 2013
    Report Date
    January 31, 2013
    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

    THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS IT WAS NOT EXPLANTED AFTER THE PATIENT¿S EXPIRATION. IN ADDITION, A DESIGN HISTORY RECORD (DHR) REVIEW WAS NOT REQUIRED/PERFORMED AS THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. PER THE INSTRUCTIONS FOR USE, VALVE REGURGITATION IS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH BIOPROSTHETIC HEART VALVE AND THE TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. THE EDWARDS SAPIEN RETROFLEX 3 TRANSFEMORAL DELIVERY SYSTEM TRAINING GUIDE INSTRUCTS THE OPERATOR ON PROPER POSITIONING AND DEPLOYMENT OF THE VALVE, INCLUDING ALL PROCEDURAL AND ANATOMICAL CONSIDERATIONS. IN ADDITION, THE PATIENT SCREENING MANUAL AND THE PROCEDURE DIDACTIC IDENTIFY SEVERAL PROCEDURAL AND ANATOMICAL FACTORS WHICH COULD CONTRIBUTE TO PARAVALVULAR LEAK, INCLUDING DEVICE MALPOSITIONING, INACCURATE MEASUREMENT OF THE NATIVE VALVE ANNULUS, IMPROPER VALVE SIZING, AND UNEVEN DISTRIBUTION OF CALCIUM ON THE NATIVE VALVE. FACTORS THAT COULD CAUSE CENTRAL REGURGITATION INCLUDE OVER EXPANSION OR ASYMMETRICAL DEPLOYMENT OF THE DELIVERY BALLOON, AND INADEQUATE COAPTATION OF PROSTHESIS LEAFLETS. IN THIS CASE THE ROOT CAUSE FOR THE MODERATE CENTRAL AI CANNOT BE CONFIRMED. THE VALVE WAS NOTED TO BE DEPLOYED IN GOOD POSITION, WITH GOOD LEAFLET FUNCTION ON TEE AND MODERATE VALVE CALCIFICATION. PER THE INSTRUCTIONS FOR USE, CARDIAC ARREST IS A POTENTIAL RISK ASSOCIATED WITH AORTIC VALVE REPLACEMENT AND BIOPROSTHETIC HEART VALVES. THE IMMEDIATE CAUSE OF SUDDEN CARDIAC ARREST IS USUALLY AN ABNORMAL HEART RHYTHM (ARRHYTHMIA). SOME OTHER HEART CONDITIONS THAT CAN LEAD TO SUDDEN CARDIAC ARREST INCLUDE CAD, MI, CARDIOMYOPATHY, VALVULAR HEART DISEASE, AND CONGENITAL HEART DISEASE. FACTORS THAT INCREASE A PATIENT¿S RISK OF CARDIAC ARREST INCLUDE SMOKING, ADVANCED AGE, GENDER, HTN, LOW BLOOD PRESSURE, OBESITY, DIABETES, A SEDENTARY LIFESTYLE, A HISTORY OF ARRHYTHMIA, AND NUTRITIONAL IMBALANCES. IN THIS CASE, THE CAUSE OF THE CARDIAC ARREST CANNOT BE CONFIRMED; HOWEVER, IT IS POSSIBLE THAT IN ADDITION TO THE PROCEDURE ITSELF, THE PATIENT¿S UNDERLYING CO-MORBIDITIES MAY HAVE CONTRIBUTED TO THE EVENT. IN ADDITION, THERE IS NO EVIDENCE OR SUGGESTION OF A DEVICE MALFUNCTION. SINCE THERE IS NO ALLEGATION OF DEVICE MALFUNCTION, OR LABELING ISSUES, AND THE DEVICE WAS NOT RETURNED FOR PHYSICAL EVALUATION, NO FURTHER INVESTIGATIONAL ACTIVITIES WILL BE PERFORMED. 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 PREVENTIVE ACTIONS ARE REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    AS REPORTED BY THE EDWARDS CLINICAL SPECIALIST (CS), DURING THE TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE, THE VALVE WAS POSITIONED AND DEPLOYED IN A 50/50 POSITION ACROSS THE NATIVE ANNULUS. POST DEPLOYMENT ANGIOGRAM DEMONSTRATED MODERATE AI. PER REPORT, THE PATIENT'S BLOOD PRESSURE AND LV FUNCTION DID NOT RECOVER POST DEPLOYMENT. A TRANSOPHAGEAL ECHOCARDIOGRAM (TEE) SHOWED GOOD VALVE LEAFLET MOVEMENT; HOWEVER, THE PATIENT PROCEEDED TO GO INTO V-FIB AND COULD NOT BE RESUSCITATED DESPITE NUMEROUS DEFIBRILLATION ATTEMPTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78494 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX26A 59103963

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR