BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 7607612 · Received June 15, 2018

    Report

    Report Number
    2015691-2018-02315
    Event Type
    Injury
    Date Received
    June 15, 2018
    Date of Event
    March 31, 2013
    Report Date
    May 24, 2018
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE TYPE OF THV VALVE IS UNKNOWN; HOWEVER, THESE ARE THE POSSIBLE 510K NUMBER FOR SAPIEN, SAPIEN XT AND SAPIEN 3: P100041, P130009, AND P140031. PER THE INSTRUCTIONS FOR USE (IFU), PERMANENT OR TRANSIENT NEUROLOGICAL EVENTS INCLUDING STROKE ARE POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE TAVR PROCEDURE AND THE USE OF THE EDWARDS THV DEVICES. ACCORDING TO LITERATURE REVIEW, AND AS DOCUMENTED AND WRITTEN BY EDWARDS LIFESCIENCES IN A CLINICAL TECHNICAL SUMMARY, STROKE IS RECOGNIZED IN THE LITERATURE AS A WELL-KNOWN COMPLICATION IN A SMALL NUMBER OF PATIENTS UNDERGOING TAVR. 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 TAVR ARE UNDOUBTEDLY MULTIFACTORIAL, THE DOMINANT ETIOLOGY LIKELY BEING INTRA-PROCEDURE EMBOLIC EVENTS. A TRANSCRANIAL DOPPLER STUDY DURING TAVR DEMONSTRATED THAT THE MAJORITY OF PROCEDURAL EMBOLIC EVENTS OCCURRED DURING BALLOON VALVULOPLASTY, MANIPULATION OF CATHETERS ACROSS THE AORTIC 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 TAVR AND AVR PATIENTS. AFTER TAVR, THERE APPEARS TO BE A MORE SIGNIFICANT PROPORTION OF EARLY STROKES OCCURRING < 24 H POST-PROCEDURE, BUT TAVR PATIENTS WITH MULTIPLE CO MORBIDITIES ARE PROBABLY AT HIGHER RISK OF BOTH EARLY AND LATE STROKES. THERE WAS NO ALLEGATION OR INDICATION A DEVICE MALFUNCTION CONTRIBUTED TO THESE ADVERSE EVENTS. IN THIS CASE, THERE IS INSUFFICIENT INFORMATION TO CONFIRM THE CAUSE OF THE REPORTED STROKES. IT IS POSSIBLE THAT THE EVENTS WERE CAUSED BY THE MECHANISM EXPLAINED IN THE TECHNICAL SUMMARY MENTIONED 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. ROBERT J. MORACA, M. A. (2018). COMBINED CAROTID ENDARTERECTOMY AND TRANSCATHETER AORTIC VALVE REPLACEMENT: TECHNIQUE AND OUTCOMES. JOURNAL OF CARDIAC SURGERY, 265-269.

    Description of Event or Problem · 1

    A SINGLE-CENTER RETROSPECTIVE STUDY OF ALL TAVR PERFORMED FROM MARCH 2013 UNTIL NOVEMBER OF 2017 WAS PUBLISHED IN THE JOURNAL ARTICLE "COMBINED CAROTID ENDARTERECTOMY AND TRANSCATHETER AORTIC VALVE REPLACEMENT: TECHNIQUE AND OUTCOME". A TOTAL OF 753 TAVR PROCEDURES WERE PERFORMED WITH THE EDWARDS SAPIEN VALVE (MODEL UNSPECIFIED). THESE CASES WERE BOTH TRANSAPICAL AND TRANSFEMORAL. SIXTEEN OF THESE PATIENTS UNDERWENT A COMBINED CAROTID ENDARTERECTOMY (CEA) AND TAVR PROCEDURE FOR SEVERE CAROTID STENOSIS AND AORTIC STENOSIS. THE FOLLOWING EVENTS OCCURRED DURING THIS PERIOD: 4 PATIENTS SUFFERED A STROKE WITHIN 30 DAYS POST TAVR PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447861 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES SAPIEN VALVE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other