BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 10881300 · Received November 21, 2020

    Report

    Report Number
    2015691-2020-14599
    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, 2015691-2020-14586, 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 (B)(4) 2015691-2020-14600.

    Additional Manufacturer Narrative · 1

    THIS IS SIXTEEN 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, 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.   LVOT OBSTRUCTION IS USUALLY DUE TO INACCURATE DEPLOYMENT (TOO VENTRICULAR) AND IS GENERALLY A RESULT OF USE ERROR OR A COMBINATION OF PATIENT AND PROCEDURAL FACTORS. IN SOME CASES, THIS WOULD NOT CAUSE HEMODYNAMIC COMPROMISE BUT MAY RESULT IN AN INCREASED LVOT GRADIENT. IN OTHER CASES, THIS COULD RESULT IN CLINICALLY SIGNIFICANT HEMODYNAMIC COMPROMISE. 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 LVOT OBSTRUCTION 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. TABLE 5 IN THE ARTICLE REPORTED THE FOLLOWING: PATIENT 4 WAS A VIMAC PATIENT WHO HAD A LVOT OBSTRUCTION THAT WAS TREATED WITH ALCOHOL SEPTAL ABLATION. SUBSEQUENTLY, THE PATIENT EXPIRED POST OP DAY 12.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1346429 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| R