BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 9512362 · Received December 23, 2019

    Report

    Report Number
    2015691-2019-04884
    Event Type
    Death
    Date Received
    December 23, 2019
    Date of Event
    November 15, 2019
    Report Date
    December 5, 2019
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPU
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: F10, H6. REFERENCE CAPA-20-00141.

    Additional Manufacturer Narrative · 1

    THE IMPLANTED VALVE MODEL AND SIZE IS UNKNOWN. POSSIBLE VALVE USED: EDWARDS SAPIEN TRANSCATHETER HEART VALVE: PMA P110021, EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE: PMA P130009, OR EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE: PMA P140031. PER THE INSTRUCTIONS FOR USE (IFU), ACCESS SITE COMPLICATIONS/CARDIOVASCULAR INJURY, INCLUDING PERFORATION OF THE VENTRICLE OR MYOCARDIUM, BLEEDING, AND INJURY AT THE SITE OF VENTRICULAR ACCESS THAT MAY REQUIRE REPAIR ARE POTENTIAL COMPLICATIONS ASSOCIATED WITH THE TRANSAPICAL TAVR PROCEDURE. PER LITERATURE REVIEW, RISK FACTORS FOR APICAL LACERATION AND BLEEDING INCLUDE FRIABLE TISSUE, FATTY APEX, CHRONIC STEROID USE, DILATED LV WITH THINNED WALLS, AND HYPERTENSION DURING REMOVAL OF THE SHEATH. WHILE PATIENT CHARACTERISTICS ARE IMPORTANT, ACHIEVING GOOD HEMOSTATIC CONTROL OF THE LV APEX IS ONE OF THE MOST CRITICAL STEPS IN ENSURING THE SUCCESS OF THE TRANSAPICAL PROCEDURE, PARTICULARLY IN THE ELDERLY WITH FRIABLE TISSUE. ADDITIONAL LITERATURE REVIEW CONFIRMS THERE IS A HIGHER INCIDENCE OF APICAL BLEEDING IN FEMALE PATIENTS AND PATIENTS OVER 80 YEARS OLD. THIS INFORMATION CORRELATES WITH REVIEW OF COMPLAINT HISTORY, REVEALING THAT THE MAJORITY OF APICAL BLEEDING COMPLICATIONS APPEAR TO BE RELATED TO SURGICAL TECHNIQUE AND/OR DISEASED VENTRICLES DURING THE INSERTION OR REMOVAL OF THE SHEATH. THE THV TRAINING MANUALS NOTE THAT REMOVAL OF THE SHEATH AND ATTEMPTED CLOSURE OF THE APICAL INCISION MAY BE ASSOCIATED WITH BLOOD LOSS. RAPID BURST PACING CAN BE USED TO LOWER THE SYSTEMIC BLOOD PRESSURE DURING SHEATH REMOVAL AND APICAL CLOSURE. THE THV TRAINING MANUALS ALSO RECOMMEND THE PHYSICIAN CONSIDER PERFORMING THE PROCEDURE UNDER FULL CPB SUPPORT FOR CERTAIN PATIENTS, INCLUDING THOSE WITH CARDIOGENIC SHOCK (CARDIAC INDEX < 2 L/MIN PER SQUARE METER) DESPITE VOLUME CHALLENGE AND INOTROPIC SUPPORT, PROFOUND LV, RV, OR BIVENTRICULAR DYSFUNCTION, AND NOTABLY FRIABLE APEX. IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION A DEVICE MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT. INVESTIGATION RESULTS SUGGEST/INDICATE IN ADDITION TO THE PROCEDURE ITSELF, PATIENT FACTORS AND CO-MORBIDITIES MAY HAVE CONTRIBUTED TO THE POST PROCEDURAL APICAL BLEEDING AND SUBSEQUENT PATIENT DEATH. 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. REFERENCE FOR THE ARTICLE: OKOH AK, SHAH A, KANG N, ALMAZ B, RESNICK J, GHAFFAR A, CHEN C, HAIK B, COHEN M, RUSSO MJ. OUTCOMES AFTER TRANSCATHETER MITRAL VALVE-IN-VALVE REPLACEMENT IN PATIENTS WITH DEGENERATED BIOPROSTHESIS: A SINGLE-CENTER EXPERIENCE. J INVASIVE CARDIOL. (2019) HTTPS://WWW.NCBI.NLM.NIH.GOV/PUBMED/31724535. THIS IS ONE OF TWO MANUFACTURER REPORTS BEING SUBMITTED FOR THIS CASE. PLEASE REFERENCE RELATED MANUFACTURER REPORT NO: 2015691-2019-04880 AND RELATED MANUFACTURER REPORT NO: 2015691-2019-04881.

    Description of Event or Problem · 1

    AS REPORTED THROUGH AN ARTICLE, "OUTCOMES AFTER TRANSCATHETER MITRAL VALVE-IN-VALVE REPLACEMENT IN PATIENTS WITH DEGENERATED BIOPROSTHESIS: A SINGLE-CENTER EXPERIENCE", BETWEEN JULY 2013 AND SEPTEMBER 2016, A TOTAL OF 15 PATIENTS HAD TRANSCATHETER MITRAL VALVE IN VALVE (TM-VIV) DUE TO DEGENERATIVE BIOLOGICAL VALVE PROSTHESIS AT A SINGLE US CENTER. OPERATIVE OUTCOMES WERE ASSESSED BOTH IN-HOSPITAL AND AT 30 DAYS. THE PRIMARY MECHANISM OF BIOPROSTHETIC VALVE FAILURE WAS STENOSIS IN 7 PATIENTS (47%) AND REGURGITATION IN 8 PATIENTS (53%). MEAN DURATION BETWEEN MITRAL VALVE REPLACEMENT (MVR) AND TRANSCATHETER MVR WAS 89 MONTHS (RANGE, 66-72 MONTHS). FAILED BIOPROSTHETIC VALVES WERE REPLACED WITH SAPIEN XT (N = 10; 67%), SAPIEN (N = 4; 26%), OR SAPIEN 3 VALVES (N = 1; 7%). PROCEDURAL SUCCESS WAS 100%. NO INTRAOPERATIVE DEATHS WERE RECORDED. AT 30-DAY FOLLOW-UP, NO REPORTS OF DEATH, DISABLING STROKE, OR REHOSPITALIZATION FOR CARDIAC REASONS WAS RECORDED. A PATIENT DEATH DUE TO CANNULATION-RELATED APICAL BLEED OCCURRED WITHIN 30 DAYS OF THE VIV PROCEDURE IN ONE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1306648 EDWARDS SAPIEN TRANSCATHETER HEART VALVE PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED NPU EDWARDS LIFESCIENCES THV VALVE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R