BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS TA DELIVERY SYSTEM

    MDR report key: 7653134 · Received June 29, 2018

    Report

    Report Number
    2015691-2018-02559
    Event Type
    Death
    Date Received
    June 29, 2018
    Date of Event
    April 1, 2015
    Report Date
    June 7, 2018
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REF. RELATED MFGR. REPORT NUMBERS: 2015691-2018-02560, 2015691-2018-02578, 2015691-2018-02579, 2015691-2018-02582, 2015691-2018-02584, 2015691-2018-02586.

    Additional Manufacturer Narrative · 1

    THE PATIENT'S WERE TREATED BETWEEN APRIL 2015 AND SEPTEMBER 2017.  THE TYPE OF TRANSAPICAL DELIVERY SYSTEM IS UNKNOWN; HOWEVER, THESE ARE THE POSSIBLE PMA NUMBERS FOR THE ASCENDRA P110021 AND CERTITUDE P140031 DELIVERY SYSTEMS.    THE DELIVERY SYSTEMS WERE NOT RETURNED TO EDWARDS LIFESCIENCES AS THEY WERE DISCARDED BY THE SITE.   PER THE INSTRUCTIONS FOR USE (IFU), POTENTIAL RISKS ASSOCIATED WITH THE OVERALL PROCEDURE INCLUDE THROMBUS FORMATION, PLAQUE DISLODGMENT, AND EMBOLIZATION THAT MAY RESULT IN MYOCARDIAL INFARCTION, STROKE, DISTAL PERIPHERAL OCCLUSION, AND/OR DEATH.  IT IS THE NATURAL TENDENCY OF THE BODY TO FORM CLOT ON FOREIGN OBJECTS IN THE VASCULAR SPACE. THESE PATIENTS ARE ANTICOAGULATED FOR THE PROCEDURE AND INTERVENTIONAL BEST PRACTICES MANDATE METICULOUS WIPING AND FLUSHING OF THE DEVICES TO PREVENT AND/OR REMOVE CLOT. THE THV TRAINING MANUALS AND IFU INSTRUCT THE OPERATOR TO ADMINISTER HEPARIN AND MAINTAIN THE ACT AT = 250 SEC. THERE ARE MULTIPLE ETIOLOGIES FOR BOWEL ISCHEMIA / INFARCTION INCLUDING EMBOLIZATION OCCURRING AFTER DEVICE MANIPULATION, BAV OR VALVE DEPLOYMENT AND THESE EVENTS CAN RESULT IN VARYING DEGREES OF PERMANENT IMPAIRMENT. ADDITIONALLY, PROLONGED HYPOTENSION CAN CONTRIBUTE TO DECREASED BOWEL PERFUSION AND ISCHEMIA POTENTIALLY LEADING TO TISSUE NECROSIS.   IN THIS CASE, THE CAUSE OF THE ISCHEMIC BOWEL AND SUBSEQUENT DEATH FOR EITHER PATIENT COULD NOT BE DETERMINED; HOWEVER, IT IS POSSIBLE THE EVENTS WERE RELATED TO 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. A REVIEW OF EDWARDS LIFESCIENCES RISK MANAGEMENT DOCUMENTATION WAS PERFORMED FOR THIS CASE.  THE REPORTED EVENT IS AN ANTICIPATED RISK OF THE TRANSCATHETER HEART VALVE PROCEDURE, ADDITIONAL ASSESSMENT OF THE FAILURE MODE IS NOT REQUIRED AT THIS TIME.  NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED.   BIBLIOGRAPHY: PRAZ, FABIEN, ET AL. "TRANSATRIAL IMPLANTATION OF A TRANSCATHETER HEART VALVE FOR SEVERE MITRAL ANNULAR CALCIFICATION." THE JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY (2018).

    Description of Event or Problem · 1

    AS REPORTED THROUGH A JOURNAL ARTICLE TITLED, "TRANSATRIAL IMPLANTATION OF A TRANSCATHETER HEART VALVE FOR SEVERE MITRAL ANNULAR CALCIFICATION" POST TVR PROCEDURE, WHILE IN THE HOSPITAL (EXACT DATES UNKNOWN), TWO (2) PATIENT'S SUFFERED ACUTE MESENTERIC ISCHEMIA WITHIN 48 HOURS OF THE PROCEDURE AND EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493023 EDWARDS TA DELIVERY SYSTEM PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED NPU EDWARDS LIFESCIENCES TA DELIVERY SYSTEM UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| O