BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS SAPIEN 3 TRANSCATHETER HEATH VALVE

    MDR report key: 11646292 · Received April 9, 2021

    Report

    Report Number
    2015691-2021-02403
    Event Type
    Death
    Date Received
    April 9, 2021
    Date of Event
    March 15, 2021
    Report Date
    April 10, 2021
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPU
    UDI-DI
    00690103194364
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE INSTRUCTIONS FOR USE (IFU) CARDIOVASCULAR INJURY, SUCH AS PERFORATION DISSECTION OF VESSELS, VENTRICLE, MYOCARDIUM OR VALVULAR STRUCTURES, IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH THE TRANSCATHETER VALVE REPLACEMENT PROCEDURE. ACCORDING TO THE THV TRAINING MANUALS, RISK FACTORS FOR AORTIC DISSECTION, HEMATOMA OR ANNULAR RUPTURE DURING THE PROCEDURE INCLUDE SIGNIFICANT THV OVER SIZING, PRESENCE OF BULKY CALCIFICATION. IN ADDITION, ADVANCED AGE, FEMALE GENDER, SMALL BODY WEIGHT, AND STEROID DEPENDENCY CAN ALSO BE CONTRIBUTING FACTORS. BULKY CALCIUM CAN INCREASE THE RISK OF CALCIFIC NODULE DISPLACEMENT INTO THE VASCULATURE, WHICH CAN LEAD TO VASCULAR INJURY. AT TIMES THE EXTENT AND DISTRIBUTION OF CALCIUM CAN IMPAIR EASE OF DELIVERY OF THE VALVE, CORRECT POSITIONING OF THE VALVE, DEPLOYMENT OF THE VALVE AND PROCEDURAL SUCCESS. THE THV TRAINING MANUALS INSTRUCT THE OPERATOR ON PROPER POSITIONING AND DEPLOYMENT OF THE VALVE, INCLUDING ALL PROCEDURAL AND ANATOMICAL CONSIDERATIONS. PHYSICIANS ARE EXTENSIVELY TRAINED BY EDWARDS BEFORE THEY ARE QUALIFIED TO USE THE SAPIEN 3 THV. TRAINING INCLUDES PATIENT SCREENING, DEVICE PREPARATION, APPROACH, DEPLOYMENT, IMAGING, PROCEDURE-SPECIFIC TRAINING MANUALS AND PROCTORED PROCEDURES. THE PATIENT SCREENING MANUAL INSTRUCTS THE OPERATOR ON PROPER VALVE LEAFLET ASSESSMENT, TAKING INTO CONSIDERATION THE LENGTH, BULKINESS AND DISTRIBUTION OF CALCIUM ON THE MITRAL BIOPROSTHESIS LEAFLETS. IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION A DEVICE MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT. INVESTIGATION RESULTS SUGGEST/INDICATE THAT PATIENT AND PROCEDURE RELATED FACTORS CONTRIBUTED TO THE EVENT. 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. THIS IS ONE OF TWO MANUFACTURER REPORTS BEING SUBMITTED FOR THIS CASE. PLEASE REFERENCE RELATED MANUFACTURER REPORT NO: 2015691-2021-02402.

    Description of Event or Problem · 1

    EDWARDS RECEIVED NOTIFICATION FROM A SALES REP THAT DURING TRANSCATHETER VALVE REPLACEMENT OF A STENOSED NATIVE MITRAL VALVE A 29MM SAPIEN 3 VALVE WAS DEPLOYED TOO ATRIAL LEAKING TO A SIGNIFICANT JET OF MITRAL REGURGITATION (MR). AS REPORTED, A LAMPOON PROCEDURE WAS DONE TO LACERATE THE ANTERIOR LEAFLET OF HER MITRAL VALVE PRIOR TO VALVE REPLACEMENT, CREATING SEVERE MR. A 29 S3 WITH +3 CC'S OF VOLUME WAS DEPLOYED BUT APPEARED TO BE TOO ATRIAL IN DEPTH (A SIGNIFICANT JET OF MR WAS VISUALIZED ON TEE). A SECOND 29 S3 WITH +3 CC'S VOLUME WAS DEPLOYED INSIDE THE FIRST AND THE MR JET WAS RESOLVED. HOWEVER, DURING DEPLOYMENT A LARGE PERICARDIAL EFFUSION WAS VISUALIZED ON TEE AS WELL. THE TEAM ATTEMPTED TO TAP THE EFFUSION AND PULLED A SIGNIFICANT AMOUNT OF BLOOD BUT IT DID NOT RESOLVE THE EFFUSION. THE PHYSICIAN OPENED THE CHEST AND ATTEMPTED TO SAVE THE PATIENT BUT EVENTUALLY IT WAS DECIDED THAT NOTHING COULD BE DONE. THE CAUSE OF THE EVENT WAS LIKELY AN INJURY TO THE ATRIO-VENTRICULAR (AV) GROOVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541713 EDWARDS SAPIEN 3 TRANSCATHETER HEATH VALVE PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED NPU EDWARDS LIFESCIENCES 9600TFX29A 7780356 00690103194364

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death| R