BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN EDWARDS SAPIEN TRANSCATHETER HEART VALVE SYSTEM

    MDR report key: 12594919 · Received October 7, 2021

    Report

    Report Number
    2015691-2021-05553
    Event Type
    Injury
    Date Received
    October 7, 2021
    Date of Event
    January 1, 2015
    Report Date
    December 7, 2021
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN ADMINISTRATIVE REVIEW OF 3500A FORMS POSTED ON THE MAUDE DATABASE SHOWED THIS MANUFACTURER REPORT WAS SUBMITTED WITH THE INCORRECT COMMON DEVICE NAME AND PRODUCT CODE. A CORRECTION TO FIELDS D2 IS BEING SUBMITTED IN THIS SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    THE STATUS OF THE DEVICE IS UNKNOWN. THIS IS ONE OF TWO MANUFACTURER REPORTS BEING SUBMITTED FOR THIS CASE. PLEASE REFERENCE RELATED MANUFACTURER REPORT NO: 2015691 - 2021 - 05552. THE DATES OF THE EVENTS ARE UNKNOWN; HOWEVER, ACCORDING TO THE ARTICLE THE STUDY PERIOD WAS FROM TO JANUARY 2015 AND MARCH 2020. FOR THIS REASON, THE FIRST DAY OF THE REPORTED STUDY PERIOD (01-JANUARY-2015) WAS USED AS THE OCCURRENCE DATE. IN THIS CASE, THE EXACT DELIVERY SYSTEM MODEL NUMBER IS NOT AVAILABLE. THEREFORE, SECTIONS D1 AND D4 OF THIS REPORT WILL REFLECT AN UNKNOWN EDWARDS DELIVERY SYSTEM. THE POSSIBLE PMA NUMBERS ASSOCIATED WITH AN EDWARDS DELIVERY SYSTEM: P130009 - EDWARDS COMMANDER DELIVERY SYSTEM WITH SAPIEN XT WITH EDWARDS COMMANDER DELIVERY SYSTEM, P140031- EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE AND EDWARDS SAPIEN 3 ULTRA HEART VALVE WITH EDWARDS COMMANDER DELIVERY SYSTEM, P200015 FOR SAPIEN WITH COMMANDER FOR PULMONIC INDICATION. 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 TPVR PROCEDURE. RUPTURE OF THE PULMONARY ARTERY MAY OCCUR WHEN MULTIPLE ATTEMPTS ARE MADE TO CROSS THE NATIVE VALVE, AND/OR WHEN EXCESSIVE FORCE IS USED. PHYSICIANS ARE EXTENSIVELY TRAINED BY EDWARDS BEFORE THEY ARE QUALIFIED TO USE THE SAPIEN TRANSCATHETER HEART VALVE (THV). THE THV TRAINING MANUALS PROVIDE GUIDANCE TO FACILITATE SAFE CROSSING OF THE NATIVE VALVE, INCLUDING CAMERA PROJECTIONS, HANDLING DURING ADVANCEMENT, AND TROUBLESHOOTING TECHNIQUES IF DIFFICULTY IS ENCOUNTERED. AS STATED, EXCESSIVE FORCE SHOULD NOT BE USED WHEN THE DEVICE HAS DIFFICULTY CROSSING THE VALVE. ADDING TENSION TO THE WIRE, PULLING BACK THE SYSTEM TO RE-ORIENT THE VALVE, AS NEEDED, AND TORQUEING OF THE FLEX CATHETER MAY BE HELPFUL IN SOLVING THE PROBLEM. 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, THERE WAS NO ALLEGATION OR INDICATION A DEVICE MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT. INVESTIGATION RESULTS SUGGEST RUPTURE OF THE PERIPHERAL PULMONARY ARTERY WAS DETECTED IN THE RIGHT LOWER LOBE SECONDARY TO STIFF WIRE INJURY. 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.

    Description of Event or Problem · 1

    AS REPORTED BY OUR AFFILIATES IN TURKEY, THROUGH THE REVIEW OF THE MEDICAL ARTICLE: ''IMPLANTATION OF THE EDWARDS SAPIEN XT AND SAPIEN 3 VALVES FOR PULMONARY POSITION IN ENLARGED NATIVE RIGHT VENTRICULAR OUTFLOW TRACT'', CORRESPONDING AUTHOR ALPER GUZELTAS, THE FOLLOWING EVENTS WERE IDENTIFIED: AFTER PERCUTANEOUS PULMONARY VALVE IMPLANTATION WITH SAPIEN XT OR SAPIEN S3 VALVES IN PATIENTS WITH DILATED NATIVE RIGHT VENTRICULAR OUTFLOW TRACT (RVOT): 1 PATIENT EXPERIENCED HEMOPTYSIS FOLLOWING THE PROCEDURE, AND RUPTURE OF THE PERIPHERAL PULMONARY ARTERY WAS DETECTED IN THE RIGHT LOWER LOBE SECONDARY TO STIFF WIRE INJURY THAT WAS EMBOLIZED WITH A VASCULAR PLUG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1487761 UNKNOWN EDWARDS SAPIEN TRANSCATHETER HEART VALVE SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES TF DELIVERY SYSTEM UNKNOWN
    1487762 UNKNOWN EDWARDS SAPIEN TRANSCATHETER HEART VALVE SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES TF DELIVERY SYSTEM UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention