BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE

    MDR report key: 7470499 · Received April 27, 2018

    Report

    Report Number
    2015691-2018-01582
    Event Type
    Injury
    Date Received
    April 27, 2018
    Date of Event
    April 1, 2018
    Report Date
    April 7, 2018
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE VALVES WERE NOT RETURNED TO EDWARDS LIFESCIENCES AS THEY REMAIN IMPLANTED IN THE PATIENTS.   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 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 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 POSTPROCEDURE 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.   IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION A DEVICE MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENTS.  THE CAUSE OF THE STROKES IS UNKNOWN, HOWEVER, MAY BE DUE TO PATIENT FACTORS (NOT PROVIDED) OR THE MECHANISMS DESCRIBED 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.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT IS UNKNOWN, THEREFORE THE FIRST DAY OF THE MONTH THAT THE CONFERENCE WAS HELD WAS USED, 1-APR-2018.  INVESTIGATION IS ONGOING.  BIBLIOGRAPHY: C. PELLEGRINI, O. HUSSER, T. RHEUDE, T. TRENKWALDER, P. MAYR, M. JONER, A. KASTRATI, H. SCHUNKERT, M. KASEL, C. HENGSTENBERG.  ¿ONE YEAR VARC-2 DEFINED CLINICAL OUTCOMES AFTER TRANSCATHETER AORTIC VALVE IMPLANTATION WITH THE SAPIEN 3¿.  STUDY PRESENTED AT: DGK 2018. PROCEEDING S OF THE 84TH ANNUAL MEETING OF THE GERMAN SOCIETY OF CARDIOLOGY.  2018 APR-5-8, MANNHEIM, BADEN-WURTTEMBERG, GERMANY.

    Description of Event or Problem · 1

    AS REPORTED BY THE EDWARDS AFFILIATE IN (B)(6), DURING DGK 2018 ¿ 84TH ANNUAL MEETING OF THE GERMAN SOCIETY OF CARDIOLOGY ¿ IT WAS PRESENTED THE STUDY ¿ONE YEAR VARC-2 DEFINED CLINICAL OUTCOMES AFTER TRANSCATHETER AORTIC VALVE IMPLANTATION WITH THE SAPIEN 3¿. THIS WAS A SINGLE CENTER STUDY OF 402 CONSECUTIVE PATIENTS THAT UNDERWENT TF TAVI WITH THE SAPIEN 3 VALVE. ACCORDING TO THE PRESENTATION, THE 1-YEAR CUMULATIVE STROKE RATE WAS 5.0% (20 PATIENTS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310494 EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9600TFX

    Patients

    Seq Age Sex Outcome Treatment
    1 Other