BEUDAMED
    FDA Adverse Event Death Summary report: N

    COMMANDER DELIVERY SYSTEM WITH S3U

    MDR report key: 9948696 · Received April 10, 2020

    Report

    Report Number
    2015691-2020-11407
    Event Type
    Death
    Date Received
    April 10, 2020
    Date of Event
    February 20, 2020
    Report Date
    February 20, 2020
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED FROM THE FIELD FOUND THE CORRECT DEVICE USED WAS A COMMANDER DELIVERY SYSTEM WITH S3U NOT A CERTITUDE DELIVERY SYSTEM. THE FOLLOWING CORRECTIONS WERE MADE. D1: CHANGED FROM CERTITUDE DELIVERY SYSTEM TO COMMANDER DELIVERY SYSTEM WITH S3U  D4: MODEL NUMBER CHANGED FROM 9620TA29 TO 9610TF23U LOT NUMBER CHANGED FROM 62447996 TO 6842807 EXPIRATION DATE CHANGED FROM 17 JUL 2021 TO 11 NOV 2021 H4: DEVICE MANUFACTURER DATE CHANGED FROM 22 JUL 2019 TO 12 NOV 2019.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: F10, H6. REFERENCE CAPA-20-00141.

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF TWO MDR¿S PLEASE REFERENCE MANUFACTURER REPORT NUMBER 2015691-2020-10984. PER THE INSTRUCTIONS FOR USE (IFU) CARDIOVASCULAR INJURY, SUCH AS PERFORATION DISSECTION OF VESSELS, VENTRICLE, MYOCARDIUM OR VALVULAR STRUCTURES, IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH THE TAVR PROCEDURE. ACCORDING TO THE THV TRAINING MANUALS, RISK FACTORS FOR AORTIC DISSECTION, HEMATOMA OR ANNULAR RUPTURE DURING THE TAVR PROCEDURE INCLUDE SIGNIFICANT THV OVER SIZING, SEVERELY OBLITERATED SINUSES OF VALSALVA, PORCELAIN AORTA AND/OR PRESENCE OF BULKY CALCIFICATION AND NARROW CALCIFIED STJ.  IN ADDITION, ADVANCED AGE, FEMALE GENDER, SMALL BODY WEIGHT, AND STEROID DEPENDENCY CAN ALSO BE CONTRIBUTING FACTORS. ASCENDING AORTIC DISSECTION MAY OCCUR WHEN MULTIPLE ATTEMPTS ARE MADE TO CROSS THE STENOTIC NATIVE VALVE, AND/OR WHEN EXCESSIVE FORCE IS USED. PHYSICIANS ARE EXTENSIVELY TRAINED BY EDWARDS BEFORE THEY ARE QUALIFIED TO USE THE SAPIEN 3 TRANSCATHETER HEART VALVE (THV). THE THV TRAINING MANUALS PROVIDE GUIDANCE TO FACILITATE SAFE CROSSING OF THE NATIVE VALVE, INCLUDING CAMERA PROJECTIONS, HANDLING DURING ADVANCEMENT, AND TROUBLESHOOTING TECHNIQUES IF DIFFICULTY IS ENCOUNTERED. AS STATED, EXCESSIVE FORCE SHOULD NOT BE USED WHEN THE DEVICE HAS DIFFICULTY CROSSING THE STENOTIC VALVE. IN THIS CASE, THE CAUSE OF THE AORTIC ROOT RUPTURE CANNOT BE DETERMINED BASED ON THE LIMITED INFORMATION PROVIDED. ADDITIONAL DETAILS ARE NOT AVAILABLE, INCLUDING AT WHAT TIME OF THE PROCEDURE THE EVENT OCCURRED AND TO WHICH OF THE DEVICES BEING USED WAS THE INJURY RELATED.  HOWEVER, THERE WAS NO ALLEGATION OR INDICATION A DEVICE MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT.  PER REPORT, THE CAUSE OF THE AORTIC RUPTURE WAS DUE TO THE PATIENT¿S ADVANCED AGE, TISSUE FRAGILITY, AND OTHER COMORBIDITIES. 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

    AS REPORTED BY AN EDWARDS LIFESCIENCES AFFILIATE IN (B)(6), A 23 MM SAPIEN XT VALVE WAS IMPLANTED IN THE AORTIC VALVE. NINE YEARS POST IMPLANT THE PATIENT DEVELOPED SEVERE DYSPNEA AND ECHO SHOWED THAT THE VALVE WAS IN NORMAL POSITION WITH EVIDENT SCLEROALCIFIC DEGENERATION OF THE ¿FLAPS¿, HIGH TRANS-PROSTHETIC GRADIENTS AND REDUCED FUNCTIONAL AREA. A VALVE-IN-VALVE PROCEDURE WAS ATTEMPTED WITH A 29 MM SAPIEN 3 VALVE. HOWEVER, THE PATIENT EXPIRED DURING THE PROCEDURE.  PER REPORT, THE CAUSE OF DEATH WAS PROBABLE AN AORTIC ROOT RUPTURE DURING THE PROCEDURE DUE TO TISSUE FRAGILITY, ADVANCED AGE, AND COMORBIDITIES. THE CERTITUDE DELIVERY SYSTEM WAS STILL IN THE PATIENT AN AORTIC RUPTURE OCCURRED. ADDITIONAL PROCEDURAL DETAILS ARE NOT AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412093 COMMANDER DELIVERY SYSTEM WITH S3U AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9610TF23U 6842807

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death