BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDWARDS TF DELIVERY SYSTEM UNKNOWN

    MDR report key: 12656397 · Received October 19, 2021

    Report

    Report Number
    2015691-2021-05767
    Event Type
    Malfunction
    Date Received
    October 19, 2021
    Date of Event
    September 27, 2021
    Report Date
    November 19, 2021
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMMANDER DELIVERY SYSTEM WAS NOT RETURNED TO EDWARDS FOR EVALUATION. WITHOUT THE DEVICE, VISUAL INSPECTION, FUNCTIONAL TESTING AND DIMENSIONAL ANALYSIS COULD NOT BE PERFORMED. REVIEW OF THE PROVIDED DEVICE PHOTOGRAPHS REVEALED AN INFLATION BALLOON BURST. PROCEDURAL PHOTOS INDICATED THE VALVE WAS FULLY INFLATED. A COMPLAINT HISTORY REVIEW FROM SEPTEMBER 2020 TO AUGUST 2021 FOR THE EDWARDS COMMANDER DELIVERY SYSTEM (ALL MODELS AND SIZES) REVEALED SIMILAR EVENTS FOR THE ASSOCIATED COMPLAINT CODES. NO EDWARDS DEVICE DEFECTS WERE IDENTIFIED IN THE EVALUATIONS. AVAILABLE INFORMATION SUGGESTS THAT PROCEDURAL FACTORS (OVER INFLATION OF THE BALLOON) AND / OR PATIENT FACTORS (CALCIFICATION) MAY HAVE CONTRIBUTED TO THE COMPLAINT EVENT. SINCE NO EDWARDS DEFECT WAS IDENTIFIED, NO CORRECTIVE OR PREVENTATIVE ACTION IS REQUIRED. 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. IN THIS CASE, THE COMPLAINT WAS ABLE TO BE CONFIRMED BASED ON REVIEW OF THE PROVIDED CASE IMAGERY. SINCE THE DEVICE WAS NOT RETURNED, ENGINEERING WAS UNABLE TO PERFORM ANY VISUAL, FUNCTIONAL, OR DIMENSIONAL ANALYSIS, AND THEREFORE NO MANUFACTURING NON-CONFORMANCES WERE ABLE TO BE IDENTIFIED. DHR AND LOT HISTORY REVIEW WERE UNABLE TO BE PERFORMED AS THE DEVICE LOT NUMBER WAS NOT PROVIDED. AS REPORTED, 'DURING THE REVIEW OF TWITTER ACCOUNT FOR A COMPLAINT, A BALLOON RUPTURE WAS FOUND. NO MORE INFORMATION COULD BE OBTAINED'. THE BALLOON WAS FULLY INFLATED PER PROVIDED IMAGERY FROM THE SITE. THE BALLOON BURST COULD BE POTENTIALLY FROM MULTIPLE FACTORS (I.E. CALCIFIED ANNULUS/LEAFLETS, ADDITIONAL INFLATION VOLUME AND ETC.). DUE TO LIMITED INFORMATION AND UNAVAILABILITY OF DEVICE, A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED AT THIS TIME. 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 AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE TRANSFEMORAL DELIVERY SYSTEM MODEL AND SIZE ARE UNKNOWN. POSSIBLE DELIVERY SYSTEM USED - EDWARDS RETROFLEX 3 DELIVERY SYSTEM - PMA P110021, EDWARDS NOVAFLEX+ DELIVERY SYSTEM - PMA P130009, OR EDWARDS COMMANDER DELIVERY SYSTEM - PMA P140031. EDWARDS LIFESCIENCES CONTINUES TO INVESTIGATE THE REPORTED EVENT AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    AS REPORTED BY OUR AFFILIATE IN GERMANY, DURING A SOCIAL MEDIA POSTING AND IMAGE REVIEW, A BALLOON RUPTURE WAS OBSERVED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1558180 EDWARDS TF DELIVERY SYSTEM UNKNOWN AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES TF DELIVERY SYSTEM UNKNOWN NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown