BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS THV VALVE UNKNOWN

    MDR report key: 12562117 · Received October 1, 2021

    Report

    Report Number
    2015691-2021-05454
    Event Type
    Death
    Date Received
    October 1, 2021
    Date of Event
    April 13, 2021
    Report Date
    October 1, 2021
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE REFERENCE RELATED MANUFACTURER REPORT NOS: 2015691-2021-05450, 2015691-2021-05451, 2015691-2021-05452, 2015691-2021-05453, 2015691-2021-05456, AND 2015691-2021-05458.

    Additional Manufacturer Narrative · 1

    CITATION: URENA, MARINA, ET AL. 'CAUSES AND PREDICTORS OF MORTALITY AFTER TRANSCATHETER MITRAL VALVE IMPLANTATION IN PATIENTS WITH SEVERE MITRAL ANNULUS CALCIFICATION.' CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS (2021). THIS IS ONE OF SEVEN MANUFACTURER REPORTS BEING SUBMITTED FOR THIS ARTICLE. THE IMPLANTED VALVE MODEL AND SIZE IS UNKNOWN. POSSIBLE VALVES USED: EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE - PMA P130009 OR EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE - PMA P140031. PER THE INSTRUCTIONS FOR USE (IFU), PERMANENT OR TRANSIENT NEUROLOGICAL EVENTS INCLUDING STROKE ARE POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE TRANSCATHETER VALVE REPLACEMENT PROCEDURE AND THE USE OF THE EDWARDS THV DEVICES. ACCORDING TO LITERATURE REVIEW, AND AS DOCUMENTED IN A CLINICAL TECHNICAL SUMMARY WRITTEN BY EDWARDS LIFESCIENCES, STROKE IS RECOGNIZED IN THE LITERATURE AS A WELL-KNOWN COMPLICATION IN A SMALL NUMBER OF PATIENTS UNDERGOING TRANSCATHETER VALVE REPLACEMENT. RISK FACTORS CORRELATING WITH A NUMBER OF PATIENT CO-MORBIDITIES HAVE BEEN IDENTIFIED. ALTHOUGH IN MANY CASES THE ROOT CAUSE OF THE EVENT IS UNABLE TO BE DETERMINED, STROKES DURING THE PROCEDURE ARE UNDOUBTEDLY MULTIFACTORIAL, THE DOMINANT ETIOLOGY LIKELY BEING INTRA-PROCEDURE EMBOLIC EVENTS. A TRANSCRANIAL DOPPLER STUDY DURING TRANSCATHETER VALVE REPLACEMENT DEMONSTRATED THAT THE MAJORITY OF PROCEDURAL EMBOLIC EVENTS OCCURRED DURING BALLOON VALVULOPLASTY, MANIPULATION OF CATHETERS ACROSS THE VALVE, AND VALVE IMPLANTATION. AN ANALYSIS IN PATIENTS UNDERGOING VALVE SURGERY REVEALED FOUR BASELINE CHARACTERISTICS AND TWO PROCEDURAL EVENTS THAT WERE ASSOCIATED WITH EARLY POST-PROCEDURE STROKE: FEMALE SEX, EF < 30%, DIABETES, AGE OLDER THAN 70 YEARS, BYPASS PROCEDURE TIME> 120 MIN, AND CALCIFICATION OF THE ASCENDING AORTA. PREDICTORS OF LATE STROKE HAVE INCLUDED FEMALE SEX, AGE OLDER THAN 75 YEARS, ATRIAL FIBRILLATION, AND A HISTORY OF OR CURRENT SMOKING. THERE WERE NO IMPORTANT DIFFERENCES IN THE FREQUENCY OF LATE STROKES BETWEEN TRANSCATHETER AND SURGICAL VALVE REPLACEMENT PATIENTS. AFTER TRANSCATHETER VALVE REPLACEMENT, THERE APPEARS TO BE A MORE SIGNIFICANT PROPORTION OF EARLY STROKES OCCURRING < 24 H POST-PROCEDURE, BUT TRANSCATHETER VALVE REPLACEMENT PATIENTS WITH MULTIPLE CO-MORBIDITIES ARE PROBABLY AT HIGHER RISK OF BOTH EARLY AND LATE STROKES. IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION A DEVICE MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT. WITH THE LIMITED INFORMATION PROVIDED THE CAUSE OF THE STROKES IS UNKNOWN BUT MAY BE RELATED TO THE MECHANISMS ABOVE. 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

    THROUGH REVIEW OF THE ARTICLE: 'CAUSES AND PREDICTORS OF MORTALITY AFTER TRANSCATHETER MITRAL VALVE IMPLANTATION IN PATIENTS WITH SEVERE MITRAL ANNULUS CALCIFICATION', THREE PATIENTS WHO RECEIVED EITHER A SAPIEN XT OR SAPIEN 3 IN THEIR NATIVE MITRAL VALVE AND PRESENTED WITH STROKES BY THEIR 30 DAY FOLLOW UPS. ONE WAS PREVIOUSLY CAPTURED IN REPORTED IN MFR REPORT NO. 2015691-2016-02531. THIS REPORT WILL CAPTURE THE OTHER TWO, ONE OF WHOM EXPIRED BY THE 30 DAY FOLLOW UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1462001 EDWARDS THV VALVE UNKNOWN AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES EDWARDS THV VALVE UNKNOWN NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R