BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE, 26MM

    MDR report key: 5509458 · Received March 17, 2016

    Report

    Report Number
    2015691-2016-00837
    Event Type
    Injury
    Date Received
    March 17, 2016
    Date of Event
    February 23, 2016
    Report Date
    February 24, 2016
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE VALVE WAS RETURNED TO EDWARDS FOR EVALUATION. THE VALVE WAS RECEIVED MISSHAPEN TO SOME DEGREE AND A LIMITED PRODUCT EVALUATION WAS PERFORMED. THERE WAS NO POTENTIAL VALVE MANUFACTURING NON-CONFORMANCE THAT WAS IDENTIFIED. THE REPORTED EVENT OF 'REGURGITATION' CANNOT BE CONFIRMED DUE TO THE CONDITION OF THE RETURNED VALVE. PER REPORT, THE PHYSICIAN DID NOT SEE ANYTHING WRONG WITH THE SAPIEN VALVE. HOWEVER THE PROCEDURE TO REMOVE THE VALVE LIKELY CAUSED THE VALVE TO MISSHAPEN. THE IFU AND TRAINING MANUALS HAVE BEEN REVIEWED AND NO INADEQUACIES HAVE BEEN IDENTIFIED WITH REGARDS TO INSTRUCTIONS, ADVERSE EVENTS, AND ADDITIONAL POTENTIAL RISKS FOR THE SUCCESSFUL USE OF THE DEVICE. PER THE INSTRUCTIONS FOR USE, VALVE REGURGITATION IS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH BIOPROSTHETIC HEART VALVES AND THE TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. THERE ARE MULTIPLE PATIENT AND PROCEDURAL FACTORS THAT ALONE OR IN COMBINATION CAN CAUSE OR CONTRIBUTE TO VALVE REGURGITATION INCLUDING, BUT NOT LIMITED TO, MALPOSITION OF THE VALVE, INACCURATE MEASUREMENT OF THE NATIVE VALVE ANNULUS, UNEVEN DISTRIBUTION OF CALCIUM ON THE NATIVE VALVE, BULKY OR SEVERE CALCIFICATION, A SEVERELY ELLIPTICAL ANNULUS SHAPE, VALVE UNDER-SIZING. THE THV TRAINING MANUALS INSTRUCT THE OPERATOR ON PROPER POSITIONING AND DEPLOYMENT OF THE VALVE, INCLUDING ALL PROCEDURAL AND ANATOMICAL CONSIDERATIONS. THE PATIENT SCREENING MANUAL INSTRUCTS THE OPERATOR ON PROPER NATIVE VALVE LEAFLET ASSESSMENT, TAKING INTO CONSIDERATION THE LENGTH, BULKINESS AND DISTRIBUTION OF CALCIUM ON THE NATIVE LEAFLETS TO DETERMINE WHETHER VALVE PERFORMANCE WILL BE IMPAIRED. THE THV TRAINING MANUALS INSTRUCT THE OPERATOR ON PROPER POSITIONING AND DEPLOYMENT OF THE VALVE, INCLUDING ALL PROCEDURAL AND ANATOMICAL CONSIDERATIONS. THE PATIENT SCREENING MANUAL INSTRUCTS THE OPERATOR ON PROPER NATIVE VALVE LEAFLET ASSESSMENT, TAKING INTO CONSIDERATION THE LENGTH, BULKINESS AND DISTRIBUTION OF CALCIUM ON THE NATIVE LEAFLETS TO DETERMINE WHETHER VALVE PERFORMANCE WILL BE IMPAIRED. IN THIS CASE, THE CAUSE FOR THE REGURGITATION CANNOT BE DETERMINED; HOWEVER, PER REPORT, THERE WAS NOT ANYTHING WRONG WITH THE VALVE. THE COMPLAINT OF ¿REGURGITATION¿ CANNOT BE CONFIRMED. NO MANUFACTURING NON-CONFORMANCE OR IFU/LABELING DEFICIENCIES WERE IDENTIFIED DURING PRODUCT EVALUATION. A REVIEW OF COMPLAINT HISTORY DID NOT REVEAL THAT OCCURRENCE RATE EXCEEDS FEBRUARY 2016 CONTROL LIMITS FOR THIS FAILURE MODE. THEREFORE, NO PRODUCT RISK ASSESSMENT AND CORRECTIVE OR PREVENTATIVE ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    AS REPORTED BY OUR (B)(4) AFFILIATE, DURING VALVE POSITIONING AND AFTER DEPLOYMENT OF A 26MM SAPIEN 3 VALVE REGURGITATION WAS NOTED. AN ANGIO REVEALED "FLOW" WHICH WENT FROM THE ANNULUS TO THE LEFT VENTRICLE. THE PATIENT'S BLOOD PRESSURE DROPPED AND A STERNOTOMY WAS PERFORMED. THE SAPIEN 3 VALVE WAS REMOVED AND A SURGICAL VALVE WAS IMPLANTED WITH A GOOD RESULT. THE PATIENT PASSED AWAY DUE TO THIS COMPLICATION OF THE PROCEDURE. PER REPORT, THE PHYSICIAN DID NOT SEE ANYTHING WRONG WITH THE SAPIEN VALVE. AS PER MEDICAL OPINION, THE CAUSE OF THE EVENT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162906 EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE, 26MM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9600TFX26

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention