BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS TRANSFEMORAL BALLOON CATHETER

    MDR report key: 3010020 · Received March 18, 2013

    Report

    Report Number
    2015691-2013-19577
    Event Type
    Death
    Date Received
    March 18, 2013
    Date of Event
    February 19, 2013
    Report Date
    February 20, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P100041
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE EDWARDS TRANSFEMORAL BALLOON CATHETER'S INSTRUCTIONS FOR USE (IFU) COMPLICATIONS ASSOCIATED WITH STANDARD CATHETERIZATION, BALLOON VALVULOPLASTY, AND THE USE OF ANGIOGRAPHY INCLUDE, BUT ARE NOT LIMITED TO: THROMBUS FORMATION, VALVULAR TEARING OR TRAUMA, PLAQUE DISLODGMENT AND EMBOLIZATION THAT MAY RESULT IN MYOCARDIAL INFARCTION AND DEATH. UNDER CONTRAINDICATION, THE IFU STATES THE PATIENT'S MEDICAL CONDITION COULD AFFECT SUCCESSFUL USE OF THIS CATHETER. IN THIS CASE, THE CORONARY OCCLUSION AND PATIENT'S DEATH APPEAR TO BE RELATED TO A COMBINATION OF PATIENT AND PROCEDURAL FACTORS. PER MEDICAL RECORDS RECEIVED, THE CORONARY OCCLUSION WAS NOT ATTRIBUTED TO MALFUNCTION OF THE EDWARDS BAV OR FINAL VALVE POSITION, BUT RATHER TO EMBOLIC/THROMBOTIC MATERIAL AND PIECES OF THE NATIVE AORTIC VALVE; POSSIBLY DISLODGED DURING BAV AND VALVE DEPLOYMENT. IN ADDITION, THIS PATIENT HAD PRE-EXISTING 30-50% OCCLUSIONS IN THE RCA AND LCA WHICH LIKELY CONTRIBUTED TO THE EVENTS. 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 EDWARDS THV PATIENT SCREENING 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 PREVENTIVE ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    AS REPORTED BY THE (B)(4) EDWARDS CLINICAL SPECIALIST, DURING A TRANSFEMORAL TAVR PROCEDURE AFTER THE BALLOON VALVULOPLASTY (BAV) WAS PERFORMED WITH THE EDWARDS TRANSFEMORAL BALLOON CATHETER, THE LEFT MAIN BECAME OCCLUDED WITH "THROMBOTIC MATERIAL AND PIECES OF THE NATIVE VALVE." THROMBOSUCTION WAS PERFORMED AND THE PATIENT WAS STABILIZED. HOWEVER, ON THE AFTERNOON OF THE TAVR PROCEDURE, THE PATIENT EXPIRED FROM RIGHT HEART FAILURE. THE RIGHT VENTRICULAR FAILURE WAS ATTRIBUTED TO THE PROCEDURAL OCCLUSION OF THE LEFT MAIN AND RIGHT CORONARY ARTERIES. PER REPORT, AFTER THE LEFT MAIN OCCLUSION WAS TREATED, A 26MM SAPIEN XT TRANSCATHETER HEART VALVE WAS IMPLANTED, WHICH LED TO THE SAME TYPE OF OCCLUSION OF THE RIGHT CORONARY ARTERY. THROMBOSUCTION WAS REPEATED; HOWEVER, THIS TIME THE PATIENT REMAINED PACEMAKER (PM) DEPENDENT AND HYPOTENSIVE DESPITE INOTROPIC SUPPORT SO AN INTRA-AORTIC BALLOON PUMP (IABP) WAS UTILIZED. THE PATIENT REMAINED ON IABP AND PM SUPPORT AND STABILIZED POST-PROCEDURE; HOWEVER, THEY EXPIRED IN THE AFTERNOON. MEDICAL RECORDS RECEIVED CONFIRMED: THE CORONARY OCCLUSION DURING BAV AND AFTER VALVE IMPLANTATION WAS CAUSED BY EMBOLIC/THROMBOTIC MATERIAL AND PIECES OF THE NATIVE VALVE; THE NATIVE LEAFLETS WERE NOT BLOCKING THE CORONARIES AFTER VALVE DEPLOYMENT; THERE WAS NO VISIBLE EMBOLIZATION TO THE CEREBRUM; AND THERE WAS PERSISTENT HEMODYNAMIC INSTABILITY WITH EVIDENCE OF RIGHT VENTRICLE INFARCTION (POOR RV FUNCTION).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113026 EDWARDS TRANSFEMORAL BALLOON CATHETER AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9350BC23 59380510

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death| R