BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 3863825 · Received June 10, 2014

    Report

    Report Number
    2015691-2014-01335
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    May 21, 2014
    Report Date
    May 21, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAPIEN INSTRUCTIONS FOR USE LIST ARRHYTHMIAS AND BLEEDING AS POTENTIAL RISKS ASSOCIATED WITH THE OVERALL PROCEDURE, AS WELL AS ADDITIONAL POTENTIAL RISKS OF CARDIAC ARREST AND DEVICE MIGRATION OR MALPOSITION ASSOCIATED WITH THE USE OF THE BIOPROSTHESIS. POST PROCEDURE AND LATE VENTRICULAR ARRHYTHMIAS CAN BE ASSOCIATED WITH PATIENT FACTORS SUCH AS POOR VENTRICULAR FUNCTION, INADEQUATE CORONARY PERFUSION, TAMPONADE, HYPOVOLEMIA OR ELECTROLYTE DEFICIENCIES (E.G. HYPOKALEMIA, HYPOCALCEMIA, HYPOMAGNESEMIA). VENTRICULAR ARRHYTHMIAS CAN ALSO BE ASSOCIATED WITH SIGNIFICANT POST PROCEDURAL BLEEDING FROM THE TA ACCESS SITE. THIS PATIENT POPULATION IS TYPICALLY ELDERLY, MAY BE NON-OPERATIVE OR HIGH RISK, HAVE COMPLEX MEDICAL HISTORIES, MULTIPLE CO-MORBIDITIES, AND LOWER CARDIAC RESERVE THAT CAN LIMIT THEIR ABILITY TO RECOVER FROM THE MEDICAL CONDITIONS ABOVE. IN THE ABSENCE OF VALVE DYSFUNCTION OR VALVE RELATED ISCHEMIA, POST-PROCEDURE AND LATE VENTRICULAR ARRHYTHMIAS ARE HIGHLY UNLIKELY TO BE RELATED TO THE IMPLANTED VALVE. IN THIS CASE, THE CAUSE OF THE INITIAL CARDIAC ARREST WAS NOT REPORTED; HOWEVER, THE PATIENT¿S COMPLEX MEDICAL HISTORY MAY HAVE CONTRIBUTED TO THE EVENT. THE SLIGHT VALVE MIGRATION MAY HAVE OCCURRED DURING THE RESUSCITATION EFFORTS; IT WAS NOT REPORTED TO HAVE AFFECTED FUNCTION. NO SPECIFIC INJURY RELATED TO THE VALVE WAS IDENTIFIED DURING THE EXPLORATORY SURGERY; THE BLEEDING APPEARS TO HAVE RESULTED FROM A RECENT SURGICAL PROCEDURE. 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 (B)(4) BASIS, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS (B)(4) REVIEW. NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    FOLLOWING THE SUCCESSFUL TRANSAPICAL DEPLOYMENT OF A 23 MM SAPIEN VALVE, THE PATIENT WAS TRANSFERRED TO CVICU IN STABLE CONDITION. FORTY-FIVE MINUTES POST TAVR, THE PATIENT CODED AND CPR WAS INITIATED. THE EKG SHOWED ST ELEVATION IN ALL LEADS. THE PATIENT WAS RETURNED TO THE OR AND CORONARY ANGIOGRAPHY SHOWED THAT THE CORONARY ARTERIES WERE PATENT, BUT THE VALVE HAD MIGRATED SLIGHTLY AORTIC AT THE LEFT CORONARY CUSP (LCC) AND WAS IN A CANTED POSITION. AN IABP WAS INSERTED DUE TO HYPOTENSION AND THE PATIENT WAS PACED VIA A TEMPORARY PACEMAKER. BLEEDING WAS NOTED AND THE PATIENT WAS GIVEN MULTIPLE UNITS OF BLOOD. THE PATIENT¿S CHEST WAS OPENED AND ADHESIONS WERE NOTED FROM A PREVIOUS STERNOTOMY PERFORMED 3 WEEKS PRIOR, WHICH LED TO ADDITIONAL BLEEDING AND FRIABLE TISSUE. TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) AND MULTIPLE CONTRAST INJECTIONS WERE USED TO DETERMINE THE SOURCE OF THE BLEEDING. THE CAUSE OF THE BLEEDING WAS NOT DETERMINED AND A PERICARDIAL WINDOW WAS PERFORMED. THE PATIENT¿S CHEST WAS CLOSED AND SHE WAS TRANSPORTED BACK TO CVICU. THE PATIENT¿S NATIVE ANNULUS DIAMETER WAS REPORTED AS 21.1 MM BY TEE WITH SEVERE NATIVE VALVE AND AORTIC ROOT CALCIFICATION. IT WAS REPORTED THAT THE ARREST POST PROCEDURE WAS NOT ATTRIBUTED TO THE VALVE MIGRATION OR CANTED POSITION (THIS MAY HAVE OCCURRED DURING CPR).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339162 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX23

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention