BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 10881284 · Received November 21, 2020

    Report

    Report Number
    2015691-2020-14586
    Event Type
    Death
    Date Received
    November 21, 2020
    Date of Event
    September 1, 2015
    Report Date
    November 4, 2020
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE REFERENCE RELATED MANUFACTURER REPORT NO: 2015691-2020-14584, 2015691-2020-14585, 2015691-2020-14587, 2015691-2020-14588, 2015691-2020-14589, 2015691-2020-14590, 2015691-2020-14591, 2015691-2020-14592, 2015691-2020-14593, 2015691-2020-14594, 2015691-2020-14595, 2015691-2020-14596, 2015691-2020-14597, 2015691-2020-14598, 2015691-2020-14599, 2015691-2020-14600.

    Additional Manufacturer Narrative · 1

    THIS IS THREE OF SEVENTEEN MANUFACTURER REPORTS BEING SUBMITTED FOR THIS CASE. PLEASE REFERENCE ARTICLE: TIWANA, JASLEEN, ET AL. "CONTEMPORARY TRANSCATHETER MITRAL VALVE REPLACEMENT FOR MITRAL ANNULAR CALCIFICATION OR RING." CARDIOVASCULAR INTERVENTIONS 13.20 (2020): 2388-2398.   THE DATES OF THE EVENTS ARE UNKNOWN; HOWEVER, ACCORDING TO THE ARTICLE THE STUDY PERIOD WAS FROM SEPTEMBER 2015 TO APRIL 2020. FOR THIS REASON, THE FIRST DAY OF THE REPORTED STUDY PERIOD (01-SEPTEMBER 2015) WAS USED AS THE OCCURRENCE DATE. IN THIS CASE, THE EXACT VALVE MODEL NUMBER IS NOT AVAILABLE. THEREFORE, OF THIS REPORT WILL REFLECT AN UNKNOWN EDWARDS SAPIEN TRANSCATHETER HEART VALVE. THE POSSIBLE PMA NUMBERS ASSOCIATED WITH AN EDWARDS SAPIEN TRANSCATHETER HEART VALVES ARE:  P110021- EDWARDS SAPIEN TRANSCATHETER HEART VALVE; P130009 - EDWARDS SAPIEN XT¿ TRANSCATHETER HEART VALVE; P140031- EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE AND EDWARDS SAPIEN 3 ULTRA HEART VALVE. THE EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE, MODEL 9600TFX, AND ACCESSORIES ARE INDICATED FOR RELIEF OF AORTIC STENOSIS IN PATIENTS WITH SYMPTOMATIC HEART DISEASE DUE TO SEVERE NATIVE CALCIFIC AORTIC STENOSIS WHO ARE JUDGED BY A HEART TEAM, INCLUDING A CARDIAC SURGEON, TO BE AT LOW RISK FOR OPEN SURGICAL THERAPY (I.E., PREDICTED RISK OF SURGICAL MORTALITY >=1% AT 30 DAYS, BASED ON THE SOCIETY OF THORACIC SURGEONS (STS) RISK SCORE AND OTHER CLINICAL CO-MORBIDITIES UNMEASURED BY THE STS RISK CALCULATOR). THE EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE, MODEL 9750TFX, AND ACCESSORIES ARE INDICATED FOR PATIENTS WITH SYMPTOMATIC HEART DISEASE DUE TO FAILURE (STENOSED, INSUFFICIENT, OR COMBINED) OF A SURGICAL BIOPROSTHETIC AORTIC OR MITRAL VALVE WHO ARE JUDGED BY A HEART TEAM, INCLUDING A CARDIAC SURGEON, TO BE AT LOW RISK FOR OPEN SURGICAL THERAPY (I.E., PREDICTED RISK OF SURGICAL MORTALITY = 8% AT 30 DAYS, BASED ON THE STS RISK SCORE AND OTHER CLINICAL CO-MORBIDITIES UNMEASURED BY THE STS RISK CALCULATOR). PER REPORT, THE DEVICE WAS USED IN AN OFF-LABEL IMPLANTATION IN THE MITRAL POSITION.  AS THERE ARE NO SPECIFIC IFU OR TRAINING MATERIALS RELATED TO MITRAL PROCEDURES, THE AVAILABLE TRAINING MATERIALS WERE REVIEWED ONLY FOR INFORMATION POTENTIALLY RELEVANT TO THE DEVICE USE. 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 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.   IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION A PRODUCT DEFICIENCY MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT. BASED ON THE LIMITED INFORMATION PROVIDED IN THE ARTICLE, THE CAUSE OF THE STROKE IS UNKNOWN. 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 THROUGH ARTICLE ¿CONTEMPORARY TRANSCATHETER MITRAL VALVE REPLACEMENT FOR MITRAL ANNULAR CALCIFICATION OR RING¿ REGARDING A  SINGLE-CENTER STUDY WAS CONDUCTED OF VALVE¿IN¿MITRAL ANNULAR CALCIFICATION (VIMAC) AND VALVE-IN-RING (VIRING) TMVR FROM SEPTEMBER 2015 TO APRIL 2020. IN-HOSPITAL AND 30-DAY OUTCOMES WERE ASSESSED. THE FOLLOWING OBSERVATIONS WERE MADE:   DURING THE 30 DAY HOSPITALIZATION, THERE WERE 4 PATIENTS THAT HAS A STROKE WITH 1 OF THE 4 PATIENTS EXPIRING. DETAILS OF THE EVENTS WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1346348 UNKNOWN EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES UNKNOWN EDWARDS SAPIEN TRANSCATHETER HEART VALVE N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| O N/A.