BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 3210349 · Received July 8, 2013

    Report

    Report Number
    2015691-2013-20550
    Event Type
    Death
    Date Received
    July 8, 2013
    Date of Event
    June 11, 2013
    Report Date
    June 12, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE INSTRUCTIONS FOR USE (IFU), ARRHYTHMIAS AND DEATH ARE POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE OVERALL TAVR PROCEDURE, INCLUDING VASCULAR AND APICAL ACCESS, USE OF ANGIOGRAPHY, BALLOON VALVULOPLASTY, USE OF CONSCIOUS SEDATION AND/OR GENERAL ANESTHESIA, AND THE BIO-PROSTHESIS IMPLANTATION. IN ADDITION, THE SAFETY OF THE BIOPROSTHESIS IMPLANTATION HAS NOT BEEN ESTABLISHED IN PATIENTS WHO HAVE SEVERE VENTRICULAR DYSFUNCTION WITH EJECTION FRACTION < 20%. ARRHYTHMIAS OCCURRING DURING OR IMMEDIATELY POST PROCEDURE CAN BE ASSOCIATED WITH PATIENT FACTORS SUCH AS POOR VENTRICULAR FUNCTION, INADEQUATE CORONARY PERFUSION, TAMPONADE, HYPOVOLEMIA OR ELECTROLYTE DEFICIENCIES. ACCORDING TO THE VALVE ACADEMIC RESEARCH CONSORTIUM (VARC) GUIDELINES, THE CLOSE ANATOMICAL RELATIONSHIP BETWEEN THE AORTIC VALVE COMPLEX AND THE BRANCHING ATRIOVENTRICULAR BUNDLE MAY PROVIDE AN EXPLANATION FOR EVENTS OF HEART BLOCK DURING AND AFTER THE TAVR PROCEDURE. PHYSICIANS ARE EXTENSIVELY TRAINED BY EDWARDS BEFORE THEY ARE QUALIFIED TO USE THE TRANSCATHETER HEART VALVE (THV). TRAINING INCLUDES PATIENT SCREENING, DEVICE PREPARATION, APPROACH, DEPLOYMENT, IMAGING, PROCEDURE-SPECIFIC TRAINING MANUALS AND PROCTORED PROCEDURES. AS A PRECAUTION, THE THV TRAINING MANUALS INSTRUCT THE OPERATOR TO MINIMIZE THE NUMBER AND DURATION OF RAPID BURST PACING EPISODES, AND ALLOW SUFFICIENT HEMODYNAMIC RECOVERY BEFORE INITIATING ANOTHER EPISODE OF RAPID PACING. IN THIS CASE, IT IS POSSIBLE A COMBINATION OF PATIENT FACTORS (MULTIPLE CO-MORBIDITIES AND LOW EF) AND PROCEDURAL FACTORS (OVERSIGHT OF HEPARIN ADMINISTRATION, ANESTHESIA AND THE TAVR PROCEDURE ITSELF) MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENTS. WHILE THE AUTOPSY WAS INCONCLUSIVE THE PHYSICIANS INDICATED THIS PATIENT¿S HEART FAILURE WAS MUCH MORE ADVANCED THAN ORIGINALLY THOUGHT GOING INTO THE TAVR CASE. THE AUTOPSY RESULTS DID NOT INDICATE A STROKE, CORONARY OCCLUSION, OR RETROPERITONEAL BLEEDING. THERE IS NO EVIDENCE THE EVENTS WERE A RESULT OF SAPIEN VALVE DYSFUNCTION. 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 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.

    Description of Event or Problem · 1

    AS REPORTED BY THE EDWARDS TERRITORY MANAGER, DURING A TRANSFEMORAL TAVR PROCEDURE THE PATIENT DECOMPENSATED AND EXPIRED. AN AUTOPSY WAS PERFORMED, HOWEVER THE RESULTS WERE INCONCLUSIVE. THERE WAS NO INDICATION OF STROKE, RETROPERITONEAL BLEED, CORONARY OBSTRUCTION OR OTHER CLOT. THE PHYSICIANS SUSPECTED THE PATIENT WAS IN GREATER HEART FAILURE THAN THEY APPRECIATED GOING INTO THE CASE. THE PATIENT¿S EJECTION FRACTION WAS THOUGHT TO BE IN THE 40¿S WHEN TAKEN FOR TAVR, BUT TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) SHOWED AN INTRA-OPERATIVE EJECTION FRACTION OF 20 PERCENT PRIOR TO THE BALLOON VALVULOPLASTY. PER REPORT, A 26MM SAPIEN VALVE WAS IMPLANTED SUCCESSFULLY WITH GOOD HEMODYNAMICS POST IMPLANT. AFTER IMPLANT AND JUST BEFORE CLOSING THE GROINS, THE TEAM REALIZED THAT HEPARIN HAD NOT BEEN ADMINISTERED. A CEREBRAL ANGIOGRAM DEMONSTRATED GOOD FLOW; HOWEVER, FEMORAL ANGIOGRAM DEMONSTRATED BILATERAL CLOTS IN THE FEMORAL ARTERIES. ANGIOJET WAS PERFORMED ON BOTH SIDES AND FLOW WAS RESTORED SATISFACTORILY. THE PATIENT'S GROINS WERE CLOSED AND HE WAS UNDRAPED AND ABOUT TO BE TRANSPORTED OUT OF THE CATH LAB WHEN HIS CARDIAC RHYTHM BECAME IRREGULAR AND HEART BLOCK WAS ASSUMED. HE BECAME HYPOTENSIVE AND WAS RE-PREPPED FOR TEMPORARY PACER INSERTION BUT HE BECAME SO HYPOTENSIVE THAT CHEST COMPRESSIONS WERE NEEDED. MULTIPLE SHOCKS WERE ADMINISTERED BUT WAS SIGNIFICANT DIFFICULTY MAINTAINING A STABLE RHYTHM. AN IMPELLA LVAD WAS INSERTED BUT THE PATIENT COULD NOT BE STABILIZED. AT 6:45PM THE IMPELLA DEVICE AND PACER WERE TURNED OFF TO WAIT FOR THE PATIENT TO PASS AWAY SINCE THERE WAS NO SUSTAINABLE PROGRESS AND THE PHYSICIANS HAD DONE EVERYTHING THEY COULD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309643 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX23

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death| R