BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 3042595 · Received April 9, 2013

    Report

    Report Number
    2015691-2013-19773
    Event Type
    Injury
    Date Received
    April 9, 2013
    Date of Event
    March 15, 2013
    Report Date
    March 15, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS IT REMAINS IMPLANTED IN THE PATIENT. PER THE INSTRUCTIONS FOR USE AND THE PATIENT SCREENING MANUAL, VALVE REGURGITATION IS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. THE EDWARDS SAPIEN RETROFLEX 3 TRANSFEMORAL DELIVERY SYSTEM TRAINING GUIDE INSTRUCTS THE OPERATOR ON PROPER POSITIONING AND DEPLOYMENT OF THE VALVE, INCLUDING ALL PROCEDURAL AND ANATOMICAL CONSIDERATIONS. FACTORS THAT CAN CONTRIBUTE TO IMPAIRED LEAFLET COAPTATION INCLUDE OVER INFLATION OF THE DEPLOYMENT BALLOON AND NATIVE LEAFLET OVERHANG. THE PATIENT SCREENING MANUAL INSTRUCTS THE OPERATOR ON PROPER NATIVE VALVE LEAFLET ASSESSMENT, TAKING INTO CONSIDERATION THE LENGTH, BULKINESS AND DISTRIBUTION OF CALCIUM ON THE NATIVE LEAFLETS TO DETERMINE WHETHER SAPIEN VALVE PERFORMANCE WILL BE IMPAIRED. IN THIS CASE, THE ROOT CAUSE OF THE REPORTED INADEQUATE COAPTATION OF THE VALVE LEAFLETS IN PATIENT CANNOT BE CONFIRMED; BUT COULD BE RELATED TO THE SEVERELY CALCIFIED NATIVE LEAFLETS. 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 PER THE EDWARDS FIELD CLINICAL SPECIALIST (FCS), AFTER DEPLOYMENT OF A SAPIEN TRANSCATHETER VALVE, ALL 3 LEAFLETS WERE VISUALIZED ON TEE BUT 'THEY SEEMED NOT TO BE COAPTING.' MODERATE-SEVERE CENTRAL AI WAS CONFIRMED WITH AORTIC PRESSURE OF 132/23 MMHG AND A DECISION WAS MADE TO IMPLANT A 2ND VALVE. THE 1ST VALVE WAS POSITIONED 50:50 ACROSS THE AORTIC ANNULUS AND THE VALVE WAS DEPLOYED UNDER RVP WITH RESPIRATIONS HELD. AFTER WITHDRAWAL OF THE DELIVERY SYSTEM THE VALVE WAS ASSESSED VIA TEE AND HEMODYNAMICALLY, AND IT WAS NOTED THAT THE PATIENT'S AO PRESSURE WAS 132/23 MMHG. TEE CONFIRMED THAT THE PATIENT HAD MOD-SEVERE CENTRAL AI. THE PIGTAIL WAS THEN GENTLY ADVANCED TO THE VALVE AND THE LEAFLETS WERE TOUCHED TO ASSURE THERE WAS MOTION FROM ALL 3 LEAFLETS. AS REPORTED, ALL 3 LEAFLETS WERE VISUALIZED BUT THEY SEEMED NOT TO BE CO-APTING. THE TAVR TEAM DECIDED THAT A 2ND VALVE NEEDED TO BE PLACED. THE IMPLANTED SAPIEN WAS RECROSSED AND A SECOND SAPIEN VALVE WAS POSITIONED WITHIN THE FIRST AND DEPLOYED IN THE SAME POSITION AS THE FIRST SAPIEN. THERE WAS IMMEDIATE IMPROVEMENT IN THE AO WAVE FORM WITH A WELL DEFINED "DICROTRIC" NOTCH. AO PRESSURE WAS NOW 130/60. TEE CONFIRMED THAT ALL CENTRAL AI WAS RESOLVED AND ONLY TRACE PVL REMAINED. PER THE REPORT, THE CAUSE OF THE COAPTATION FAILURE WAS NOT DETERMINED BY THE TEAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144994 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX26

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Required Intervention