BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 3833821 · Received May 27, 2014

    Report

    Report Number
    2015691-2014-01240
    Event Type
    Death
    Date Received
    May 27, 2014
    Date of Event
    April 19, 2014
    Report Date
    May 1, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE INSTRUCTIONS FOR USE (IFU), THROMBOSIS AND EMBOLIZATION OF AIR, CALCIFICATION OR THROMBUS ARE POTENTIAL ADVERSE EVENTS ASSOCIATED WITH TRANSCATHETER AORTIC VALVE REPLACEMENT AND BIOPROSTHETIC HEART VALVES. ACCORDING TO (B)(6), SOME CAUSES FOR THROMBOEMBOLISM NOT ASSOCIATED WITH INVASIVE PROCEDURES INCLUDE ADVANCED AGE, ATHEROSCLEROSIS, CANCER, PREVIOUS MI, HEART FAILURE, DM, HTN, A SEDENTARY LIFESTYLE, CERTAIN MEDICATIONS, AND SMOKING. 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 LEADING TO MULTI-ORGAN FAILURE COULD NOT BE DETERMINED. IN ADDITION TO THE RECENT PROCEDURE, THE PATIENT HAD BEEN HAVING ABDOMINAL PAIN AND DIARRHEA IN THE DAYS PRECEDING THE TAVR. NO ALLEGATION HAS BEEN MADE RELATING THE PATIENT¿S DEATH TO THE SAPIEN VALVE OR OTHER EDWARDS DEVICE. 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 (B)(4) BASIS, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS (B)(4) REVIEW. NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    TWO DAYS AFTER A SUCCESSFUL TRANSFEMORAL TAVR PROCEDURE THE PATIENT STARTED HAVING SYMPTOMS OF ISCHEMIC BOWEL. THERE WERE NO COMPLICATIONS DURING THE CASE. THE PHYSICIAN REPORTED THAT THE PATIENT WAS DOING WELL ON THE FIRST 24 HOURS POST PROCEDURE, BUT THEN THE PATIENT DEVELOPED V-TACH AND NO BOWEL MOVEMENT. SUBSEQUENTLY THE PATIENT DIED OF MULTI-ORGAN FAILURE DUE TO ISCHEMIC BOWEL. THE PHYSICIAN THINKS THAT THE ARRHYTHMIA WAS RELATED TO THE METABOLIC ISSUES. NO ABNORMALITIES WERE NOTED WITH VALVE, AND THE DEATH WAS NOT THOUGHT TO BE VALVE RELATED. THE CAUSE OF THE ISCHEMIC BOWEL WAS NOT DETERMINED. THE PATIENT HAD BEEN HAVING ABDOMINAL PAIN AND DIARRHEA IN THE DAYS PRECEDING THE TAVR PROCEDURE, BECAUSE OF THOSE SYMPTOMS, IT IS IMPOSSIBLE TO KNOW WHETHER THE BOWEL WAS ALREADY BECOMING ISCHEMIC PRIOR TO THE PROCEDURE OR IF IT WAS CAUSED BY AN EMBOLIC EVENT DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311475 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX26A

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Death