BEUDAMED
    FDA Adverse Event Death Summary report: N

    SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 3382364 · Received October 2, 2013

    Report

    Report Number
    2015691-2013-21197
    Event Type
    Death
    Date Received
    October 2, 2013
    Date of Event
    September 10, 2013
    Report Date
    September 10, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE INSTRUCTIONS FOR USE (IFU), CORONARY FLOW OBSTRUCTION IS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE TAVR PROCEDURE. THE IFU CAUTIONS THAT THE SAFETY AND EFFECTIVENESS HAVE NOT BEEN ESTABLISHED FOR PATIENTS WITH BULKY CALCIFIED AORTIC VALVE LEAFLETS IN CLOSE PROXIMITY TO CORONARY OSTIA. CORONARY OBSTRUCTION CAN RESULT IN MYOCARDIAL ISCHEMIA OR INFARCTION DUE TO OBSTRUCTION OF THE CORONARY BLOOD FLOW AND MAY REQUIRE INTERVENTION (E.G. PCI). THERE ARE MULTIPLE PATIENT FACTORS THAT COULD CONTRIBUTE TO CORONARY OBSTRUCTION BY THE PROSTHETIC VALVE OR NATIVE VALVE LEAFLETS, INCLUDING A MINIMAL DISTANCE BETWEEN THE NATIVE ANNULUS AND THE CORONARY OSTIA, BULKY CALCIFICATION, LONG NATIVE LEAFLETS, AND OBLITERATED CORONARY SINUSES. PROCEDURAL FACTORS SUCH AS DEPLOYMENT OF THE BIOPROSTHETIC HEART VALVE TOO AORTIC AND SIGNIFICANT VALVE OVER SIZING COULD ALSO CONTRIBUTE TO THIS COMPLICATION. THE EDWARDS THV MANUALS ADVISE THE OPERATOR ON PRE-PROCEDURE ASSESSMENT OF THE AORTIC VALVE, ROOT, AND CORONARY ANATOMY. 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. EVALUATION OF THE DISTANCE OF THE RIGHT AND LEFT CORONARY OSTIA FROM THE AORTIC ANNULUS IN RELATION TO THE THV FRAME HEIGHT IS EMPHASIZED. OPERATORS ARE INSTRUCTED TO USE CAUTION WITH: BULKY CALCIFICATION (> 4 MM THICKNESS), SEVERELY OBLITERATED SINUSES OF VALSALVA (SOV <5 MM LARGER THAN STJ), SIGNIFICANT VALVE OVERSIZING (= 4 MM). THE TRAINING ADVISES THAT PATIENTS THAT MEET ALL THREE OF THESE CONDITIONS SHOULD NOT BE TREATED: BULKY LEAFLET CALCIFICATION; SEVERELY OBLITERATED SOV; AND, SIGNIFICANT VALVE OVERSIZING. THE TRAINING MANUALS ALSO PROVIDE THE FOLLOWING TIPS FOR DETECTING RISK FOR LEFT MAIN OCCLUSION: AORTOGRAM OR TEE PRIOR TO THV IMPLANTATION TO REVEAL BULKY CALCIFIED LEAFLETS; DURING PRE-DILATATION, NOTE BULKY CALCIFICATION ON VALVE MOVING TOWARDS OSTIUM ON LEFT MAIN; AND CONSIDER AORTOGRAM DURING VALVULOPLASTY. IN THIS CASE THE EXACT CAUSE FOR THE EVENT COULD NOT BE DETERMINED; HOWEVER PATIENT (OBLITERATED SOV, CLOSE PROXIMITY OF LEFT CORONARY OSTIA TO THE NATIVE ANNULUS, AND SIGNIFICANT VALVE OVERSIZING) AND PROCEDURAL FACTORS COULD HAVE CAUSED OR CONTRIBUTED TO THE OCCLUSION OF THE LEFT CORONARY ARTERY. 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

    IT WAS REPORTED BY THE EDWARDS FIELD CLINICAL SPECIALIST THAT PRIOR TO THE DEPLOYMENT OF THE SAPIEN VALVE A DECISION WAS MADE TO PROPHYLACTICALLY PLACE A GUIDEWIRE IN THE LEFT MAIN CORONARY ARTERY. REPORTEDLY AFTER SUCCESSFUL TRANSAPICAL DEPLOYMENT OF A 23 MM SAPIEN VALVE IN A 50:50 POSITION, AN AORTIC ROOT INJECTION DEMONSTRATED PATENT RIGHT AND LEFT CORONARY ARTERIES . THE ASCENDRA 3 SHEATH WAS THEN REMOVED HOWEVER, APPROXIMATELY 15 MINUTES LATER THE PATIENT BECAME HEMODYNAMICALLY UNSTABLE AND WAS PLACED URGENTLY ON CORONARY PULMONARY BYPASS (CPB). AFTER APPROXIMATELY 14 MINUTES OF DIFFICULT ARTERIAL CANNULATION, WHILE UNDERGOING CPR AND PHARMACOLOGIC SUPPORT, THE PATIENT WAS PLACED ON CPB. ANGIOGRAPHY REVEALED REDUCED FLOW INTO THE LEFT CORONARY ARTERY (LCA) AND THIS WAS TREATED WITH A CORONARY BALLOON AND PLACEMENT OF A BARE METAL STENT. AFTER SUCCESSFUL STENT PLACEMENT AND RESTORATION OF FLOW INTO THE LCA, THE PATIENT¿S HEMATOCRIT WAS FALLING AND NOT STABILIZING DESPITE CONTINUED BLOOD AND VOLUME INFUSIONS. IT WAS NOTED THAT THE PATIENT'S ABDOMEN WAS GROWING AND BECOMING VERY TENSE. THE PATIENT WAS PLACED ON AN INTRA AORTIC BALLOON PUMP (IABP) AND THE PACEMAKER WAS REINSERTED. DESPITE THESE MEASURES THE PATIENT EXPIRED. A REVIEW OF PROCEDURAL IMAGES WITH THE PROCEDURE PROCTOR, SURMISED THAT DESPITE THE APPEARANCE OF PATIENT CORONARY ARTERIES WITH THE ROOT AORTOGRAM, A SELECTIVE CORONARY STUDY COULD HAVE BEEN PERFORMED REVEALING THE SLOW PERFUSION TO THE LEFT CORONARY SYSTEM. ADDITIONALLY THE CAUSE OF DEATH WAS PRESUMED TO BE DUE TO TRAUMA OF THE ILIO-FEMORAL ARTERIES, CAUSED BY THE CPB ARTERIAL CANNULATION THAT COULD NOT BE REPAIRED. ADDITIONAL INFORMATION NOTED THE PATIENT¿S NATIVE ANNULUS MEASURED 17MM IN DIAMETER. THERE WAS MODERATE NATIVE VALVE/LEAFLET CALCIFICATION, MODERATE AORTIC ROOT CALCIFICATION, AND MILD MITRAL ANNULAR CALCIFICATION (MAC). THE PATIENT¿S SINUS OF VALSALVA (SOV) DIAMETER MEASURED 21.7MM AND THE SINOTUBULAR JUNCTION (STJ) DIAMETER MEASURED 26.6MM. REPORTEDLY DURING PRE-CASE DISCUSSION IT WAS NOTED BOTH THE LEFT AND RIGHT CORONARY ARTERIES OF THE PATIENT WERE LOW WITH MEASUREMENTS OF 9.4 AND 9.9 MM RESPECTIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497543 SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX23

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death