BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 2830331 · Received November 13, 2012

    Report

    Report Number
    2015691-2012-18642
    Event Type
    Injury
    Date Received
    November 13, 2012
    Date of Event
    October 17, 2012
    Report Date
    October 17, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    PMA / PMN Number
    P100041
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS IT REMAINS IMPLANTED IN THE PATIENT. PER THE INSTRUCTIONS FOR USE (IFU), EMBOLIZATION: AIR, CALCIFICATION OR THROMBUS ARE POTENTIAL ADVERSE EVENTS ASSOCIATED WITH BIOPROSTHETIC HEART VALVES AND THE TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. IN THIS CASE, THE PERFORATIONS OF THE LV WERE REPORTED TO BE CAUSED BY THE EXCHANGE OF CATHETERS AND GUIDEWIRES PRIOR TO THE INTRODUCTION OF ANY EDWARDS DEVICES. THE CORONARY OBSTRUCTION APPEARS TO HAVE RESULTED FROM THROMBUS/SPASM DUE TO A STATE OF LOW FLOW FOR AN EXTENDED PERIOD OF TIME DURING THE PROCEDURE. THERE WAS NO REPORT OF VALVE THROMBOSIS OR THROMBOSIS EMANATING FROM THE VALVE. 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 PREVENTATIVE ACTIONS ARE REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    AS REPORTED BY THE EDWARDS FIELD CLINICAL SPECIALIST, THE PATIENT DEVELOPED ANTEROLATERAL ISCHEMIA DURING THE TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE, AND WAS NOTED TO HAVE DEVELOPED CORONARY ARTERY THROMBOSIS. PRIOR TO DEPLOYMENT OF THE SAPIEN VALVE, THERE WERE SOME PROCEDURAL COMPLICATIONS. ONCE THE PHYSICIAN HAD EXCHANGED THE 0.035 260 STRAIGHT WIRE FOR THE .035 260 3CM EXTRA STIFF J WIRE, A LARGE PERICARDIAL EFFUSION WAS NOTED ON ECHO. IT WAS ALSO NOTED AT THIS TIME THAT THE RIGHT ATRIUM AND RIGHT VENTRICLE WERE NOT MOVING NORMALLY. IT WAS DECIDED TO PROCEED WITH THE PROCEDURE AND THEN ADDRESS THE EFFUSION. A BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED WITH A 22 X 4CM ZMED BALLOON. AT THIS TIME, THE PATIENT'S AO PRESSURE WAS 55/40 WITH A HEART RATE (HR) OF 129 BEATS PER MINUTE (BPM). THE SAPIEN VALVE WAS DEPLOYED 50:50 ACROSS THE NATIVE AORTIC ANNULUS UTILIZING RAPID VENTRICULAR PACING (RVP). POST VALVE DEPLOYMENT, NO CENTRAL AORTIC INSUFFICIENCY (CAI) OR PARAVALVULAR LEAK (PVL) WAS NOTED. SUBSEQUENTLY THE PHYSICIANS PROCEEDED TO ADDRESS THE EFFUSION AND PERFORMED A PERICARDIAL WINDOW. THE BLOOD WAS NOTED TO BE BRIGHT RED AND DEEMED TO BE ARTERIAL. CARDIAC MASSAGE WAS PERFORMED AND THE PATIENT WAS PLACED ON CPB; 564CC OF BLOOD WAS RECOVERED THROUGH THE CELL SAVER, 2 UNITS OF BLOOD WERE GIVEN, AND THE PATIENT WAS STABILIZED WITH AN AO PRESSURE OF 112/55, PA: 35/22 AND A HR OF 96BPM. THE PATIENT'S CORONARY ARTERIES WERE THEN VISUALIZED THROUGH ANGIOGRAPHY TO CONFIRM PATENCY. THE PHYSICIAN IDENTIFIED THREE PERFORATIONS IN THE LEFT VENTRICLE (LV) AND ATTEMPTED TO REPAIR THEM. THE LV CONTINUED TO DETERIORATE AND A HEMATOMA FORMED ALONG THE ATRIOVENTRICULAR GROOVE ABOUT 6 INCHES LONG. A PERICARDIAL PATCH WAS THEN PLACED ON THE LV WITH GLUE. THE PATIENT WAS WEANED OFF OF CPS AND GIVEN PROTAMINE. THE PATIENT THEN DEVELOPED ANTEROLATERAL ISCHEMIA. A JL4 GUIDING CATHETER WAS INTRODUCED AND THE MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WAS STENTED. THE PATIENT CONTINUED TO BE ISCHEMIC AND THE RIGHT CORONARY ARTERY (RCA) WAS IMAGED AND NOTED TO BE OCCLUDED DISTALLY AND HAD CLOT IN THE MID-PORTION. THE RCA WAS ALSO STENTED. THE PATIENT THEN BECAME MODERATELY STABLE, HER CHEST WAS PACKED AND SHE WAS MOVED TO THE SICU WITH AN OPEN CHEST. THE PATIENT RECEIVED 7 UNITS OF BLOOD AND 2 UNITS OF PLATELETS IN THE OPERATING ROOM. ADDITIONAL INVESTIGATION REVEALED THE FOLLOWING: PER REPORT, THE LV PERFORATIONS WERE CAUSED BY THE INITIAL CROSSING OF THE NATIVE VALVE, INTRODUCTION OF THE DIAGNOSTIC AL-1 CATHETER, AND THEN THE EXCHANGE OF THE INITIAL STANDARD WIRE FOR THE EXTRA-SUPPORT GUIDEWIRE. THIS OCCURRED PRIOR TO THE INTRODUCTION OF THE EDWARDS DELIVERY SYSTEM. NO CORONARY LESIONS WERE NOTED PRIOR TO THE PROCEDURE. THE CORONARY STATUS CHANGE WAS ATTRIBUTED TO A STATE OF LOW FLOW FOR AN EXTENDED PERIOD OF TIME,RESULTING IN THROMBUS/SPASM. DURING THE PROCEDURE, THE ACT WAS MAINTAINED GREATER THAN 250 SECONDS. WHEN THE PATIENT WAS PLACED ON CPS HER ACT WAS MAINTAINED GREATER THAN 450 SECONDS. HOWEVER, WHEN CPS WAS TERMINATED PROTAMINE WAS ADMINISTERED. IT WAS UNKNOWN HOW MUCH TOTAL HEPARIN WAS GIVEN DURING THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EDWARDS SAPIEN TRANSCATHETER HEART VALVE TRANSCATHETER HEART VALVE LWR EDWARDS LIFESCIENCES 9000TFX23

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention