BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS TRANSFEMORAL BALLOON CATHETER

    MDR report key: 3080765 · Received April 26, 2013

    Report

    Report Number
    2015691-2013-19932
    Event Type
    Death
    Date Received
    April 26, 2013
    Date of Event
    March 17, 2013
    Report Date
    April 2, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P100041
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE EDWARDS TRANSFEMORAL BALLOON CATHETER'S INSTRUCTIONS FOR USE (IFU), DEATH IS A COMPLICATION ASSOCIATED WITH STANDARD CATHETERIZATION, BALLOON VALVULOPLASTY, AND THE USE OF ANGIOGRAPHY. UNDER THE CONTRAINDICATION SECTION OF THE IFU, IT IS INDICATED THAT PATIENT'S MEDICAL CONDITIONS COULD AFFECT SUCCESSFUL USE OF THIS CATHETER. THESE PATIENTS CAN BE NON-OPERATIVE OR HIGH RISK, HAVE COMPLEX MEDICAL HISTORIES AND MULTIPLE COMORBIDITIES. THEY ARE ROUTINELY ADMINISTERED MULTIPLE VASOACTIVE DRUGS DURING THE PROCEDURE AND ARE INTENTIONALLY MADE HYPOTENSIVE, UTILIZING RAPID VENTRICULAR PACING TO FACILITATE ACCURATE VALVE DEPLOYMENT. AS A RESULT OF THESE FACTORS, INTRA-OPERATIVE ARRHYTHMIAS AND HYPOTENSION ARE VERY COMMON DURING THE TAVR PROCEDURE. IN THIS CASE, THE EXACT CAUSE FOR THE ADVERSE EVENTS IS UNKNOWN, HOWEVER, PER REPORT, THERE IS NO ALLEGATION OF A DEVICE MALFUNCTION, AND IT IS LIKELY RELATED TO A COMBINATION OF SIGNIFICANT PATIENT CO-MORBIDITIES IN ADDITION TO THE PROCEDURE ITSELF. SINCE THERE IS NO ALLEGATION OF DEVICE MALFUNCTION, OR LABELING ISSUES, AND THE DEVICE WAS NOT RETURNED FOR PHYSICAL EVALUATION, NO FURTHER INVESTIGATIONAL ACTIVITIES WILL BE PERFORMED. THE IFU AND EDWARDS THV PATIENT SCREENING 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 PREVENTIVE ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    AS REPORTED BY THE EDWARDS CLINICAL SPECIALIST FROM THE (B)(4), A PATIENT EXPIRED FIVE DAYS POST TAVR PROCEDURE. DURING THE TAVR PROCEDURE, THE PATIENT ARRESTED FOLLOWING THE INITIAL BALLOON VALVULOPLASTY (BAV) AND THEN WENT ON BYPASS. THE TAVR PROCEDURE WAS SUCCESSFUL AND OTHERWISE STRAIGHTFORWARD WITHOUT ANY VALVE RELATED PROBLEM BUT THE PATIENT'S MYOCARDIUM DID NOT RECOVER AFTER RAPID PACING WHICH IS LIKELY ASSOCIATED WITH AN UNDERLYING COMPROMISED CARDIAC CONDITION. PER THE IMPLANTING PHYSICIAN, THE PATIENT DIED OF CARDIAC FAILURE. THERE WAS NO INDICATION THE PATIENT'S DEATH WAS RELATED TO AN EDWARDS DEVICE. ADDITIONAL DETAILS OF THIS EVENT AND THE PATIENT'S MEDICAL HISTORY WERE REQUESTED, HOWEVER, THE FACILITY/PHYSICIAN DECLINED TO PROVIDE ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180764 EDWARDS TRANSFEMORAL BALLOON CATHETER AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9350BC23 59318875

    Patients

    Seq Age Sex Outcome Treatment
    1 Death