BEUDAMED
    FDA Adverse Event Death Summary report: N

    SAPIEN XT VALVE

    MDR report key: 12415022 · Received September 2, 2021

    Report

    Report Number
    2015691-2021-04973
    Event Type
    Death
    Date Received
    September 2, 2021
    Date of Event
    January 1, 2014
    Report Date
    September 2, 2021
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPU
    PMA / PMN Number
    P130009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATE OF THE EVENT(S) IS UNKNOWN. ACCORDING TO THE ARTICLE THIS EVENT OCCURRED IN 2014. FOR THIS REASON, THE FIRST DAY OF THE YEAR WAS USED AS THE OCCURRENCE DATE. ARTICLE REFERENCE: ENG, MARVIN H., FARAJ KARGOLI, DEE DEE WANG, TIBERIO M. FRISOLI, JAMES C. LEE, PEDRO S. VILLABLANCA, HASSAN NEMEH ET AL. SHORT AND MID TERM OUTCOMES IN PERCUTANEOUS MITRAL VALVE REPLACEMENT USING BALLOON EXPANDABLE VALVES. CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS (2021). PER THE INSTRUCTIONS FOR USE (IFU), VALVE MALPOSITION AND EMBOLIZATION ARE KNOWN POTENTIAL COMPLICATIONS ASSOCIATED WITH 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 MALPOSITION/EMBOLIZATION, INCLUDING, BUT NOT LIMITED TO, IMPROPER POSITIONING PRIOR TO DEPLOYMENT, POOR IMAGE INTENSIFIER ANGLE, POOR COAXIAL ALIGNMENT OF THE VALVE/DELIVERY SYSTEM, LOSS OF PACING CAPTURE, RAPID DEPLOYMENT AND MOVEMENT OF THE DELIVERY SYSTEM BY THE OPERATOR. THE EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE IS INDICATED FOR PATIENTS WITH SEVERE SYMPTOMATIC CALCIFIED NATIVE AORTIC VALVE STENOSIS. DEPLOYMENT OF THE SAPIEN XT VALVE IN A NATIVE MITRAL VALVE IS NOT INDICATED PER THE LABELING; THEREFORE THE LABELING (IFUS AND EW TRAINING MANUALS) DO NOT INSTRUCT THE OPERATOR HOW TO POSITION THE SAPIEN XT VALVE IN THIS SCENARIO. IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION A PRODUCT DEFICIENCY MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT. THE CAUSE FOR THE VALVE EMBOLIZATION COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED BY THE AUTHORS. IT IS POSSIBLE THAT PROCEDURAL FACTORS (DEPLOYMENT OF THE VALVE IN MAC) MAY HAVE CONTRIBUTED TO THE EVENT. 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

    PER THE ARTICLE, SHORT AND MIDTERM OUTCOMES IN PERCUTANEOUS MITRAL VALVE REPLACEMENT USING BALLOON EXPANDABLE VALVES, FROM AUGUST 2013 TO DECEMBER 2019, A TOTAL OF 88 CASES OF TRANSCATHETER MITRAL VALVE REPLACEMENT (TMVR) WERE PERFORMED AT SINGLE CENTER. A TOTAL OF 38, 31, AND 19 PATIENTS WERE TREATED WITH A VALVE IN VALVE, VALVE IN RING, OR VALVE IN NATIVE MITRAL ANNULUS, RESPECTIVELY. POST IMPLANT OF A 26MM SAPIEN XT VALVE IN THE NATIVE MITRAL POSITION WITH MITRAL ANNULAR CALCIFICATION (MAC), THE VALVE EMBOLIZED. THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1310294 SAPIEN XT VALVE PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED NPU EDWARDS LIFESCIENCES 9300TFX26 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death