BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE

    MDR report key: 4103330 · Received September 19, 2014

    Report

    Report Number
    2015691-2014-02193
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    August 27, 2014
    Report Date
    August 27, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P130009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    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 TRAINING 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. THE MANUALS ADVISE THAT A SHORTER DISTANCE BETWEEN THE ANNULUS AND THE CORONARY OSTIA INCREASES THE RISK OF OCCLUSION. INCREASED RISK OF CORONARY OCCLUSION CAN OCCUR WITH DISTANCE LESS THAN 10MM FOR A 23MM VALVE AND LESS THAN 11MM FOR A 26MM VALVE. 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, (3) 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 AS REPORTED THE CAUSE OF THE MALPOSTION WAS REPORTEDLY DUE TO AN ACUTE COPLANAR VIEW AND THE PHYSICIAN MISJUDGING THE ANGLE. THIS MALPOSITION IN COMBINATION WITH THE LOW CORONARY OSTIA HEIGHT CONTRIBUTED TO THE CORONARY OBSTRUCTION. 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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION PROVIDED AS DOCUMENTED IN A JOURNAL ARTICLE RECEIVED, STATED THE PATIENT REMAINED HYPOTENSIVE ON IMPELLA SUPPORT, AND TEE SHOWED A SEVERELY REDUCED RIGHT VENTRICULAR FUNCTION AND AN UNDER FILLED LEFT VENTRICULAR CAVITY AFTER CORONARY INTERVENTION. THE DECISION WAS TAKEN TO INSERT A TANDEM HEART DEVICE FOR RIGHT VENTRICULAR SUPPORT. THE OUTPUT OF THE TANDEM HEART WAS MATCHED WITH THE IMPELLA CP TO DELIVER A CARDIAC OUTPUT OF APPROXIMATELY 3.5 L/MIN. THE PATIENT WAS WEANED OFF VASOPRESSORS OVER THE NEXT 12 H. SERIAL ECHOCARDIOGRAPHY CONFIRMED AN IMPROVED BIVENTRICULAR FUNCTION, SUCH THAT BOTH SUPPORT DEVICES WERE REMOVED AFTER 24 H AND THE PATIENT WAS DISCHARGED HOME TWO DAYS LATER. AT THE 30-DAY FOLLOW UP EXAMINATION, ECHOCARDIOGRAPHY DEMONSTRATED A NORMAL BIVENTRICULAR FUNCTION. BIBLIOGRAPHY: SINGH, V., HELDMAN, A. (2015). EMERGENT PERCUTANEOUS BIVENTRICULAR SUPPORT DURING TRANSCATHETER AORTIC VALVE REPLACEMENT: THE JOURNAL OF HEART VALVE DISEASE 24:313-315.

    Description of Event or Problem · 1

    DURING THE TRANSFEMORAL DEPLOYMENT OF A SAPIEN XT IT WAS DEPLOYED IN 90/10 AORTIC/VENTRICULAR POSITION, THE MALPOSITION WAS REPORTEDLY DUE TO AN ACUTE COPLANAR VIEW AND THE PHYSICIAN MISJUDGING THE ANGLE. THE TOO AORTIC DEPLOYMENT FOR THE VALVE RESULTED IN THE OCCLUSION OF THE LEFT MAIN CORONARY ARTERY. PRIOR TO VALVE DEPLOYMENT A GUIDE WIRE WAS INSERTED INTO THE CORONARY ARTERY. IT WAS NOTED THE NATIVE LEAFLET WAS BEING PUSHED ONTO THE CORONARY OSTIA BY THE STENT STRUTS. A STENT WAS PLACED IN THE CORONARY ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584283 EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9300TFX26

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention