BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS COMMANDER DELIVERY SYSTEM

    MDR report key: 9560609 · Received January 7, 2020

    Report

    Report Number
    2015691-2020-10072
    Event Type
    Injury
    Date Received
    January 7, 2020
    Date of Event
    January 1, 2012
    Report Date
    December 17, 2019
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: F10, H6. REFERENCE CAPA: 20-00141.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION H10: NARRATIVE TEXT. THIS IS ONE OF SEVEN MANUFACTURER REPORTS BEING SUBMITTED FOR THIS CASE. PLEASE REFERENCE RELATED MANUFACTURER REPORT NO: 2015691-2020-10069, RELATED MANUFACTURER REPORT NO: 2015691-2020-10070, RELATED MANUFACTURER REPORT NO: 2015691-2020-10071, RELATED MANUFACTURER REPORT NO: 2015691-2020-10073, RELATED MANUFACTURER REPORT NO: 2015691-2020-10074 AND RELATED MANUFACTURER REPORT NO: 2015691-2020-10076.

    Additional Manufacturer Narrative · 1

    PER THE INSTRUCTIONS FOR USE (IFU), CARDIOVASCULAR INJURIES, INCLUDING PERFORATION OR DISSECTION OF VESSELS, VENTRICLE, MYOCARDIUM OR VALVULAR STRUCTURES, ARE POTENTIAL ADVERSE EVENTS ASSOCIATED WITH STANDARD CARDIAC CATHETERIZATION, BALLOON VALVULOPLASTY AND THE TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. THERE ARE SEVERAL POTENTIAL ETIOLOGIES FOR VENTRICULAR PERFORATION DURING A TAVR PROCEDURE, INCLUDING PERFORATION BY THE GUIDEWIRE, THE DELIVERY SYSTEM, OR THE TRANSVENOUS PACER (TVP) LEAD. PHYSICIANS ARE EXTENSIVELY TRAINED BY EDWARDS BEFORE THEY ARE QUALIFIED TO USE THE SAPIEN 3 TRANSCATHETER HEART VALVE (THV). TRAINING INCLUDES PROPER GUIDEWIRE POSITIONING, FIXATION OF THE TVP TO PREVENT VENTRICLE PERFORATION, AND CAREFUL MANIPULATION OF DEVICES. PER THE PROCEDURE DIDACTIC, PATIENTS WITH SMALL VENTRICLES ARE AT PARTICULARLY HIGH RISK FOR VENTRICULAR PERFORATION. IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION A DEVICE MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT. ALTHOUGH THE EXACT CAUSE AND TIMING OF THE EVENT COULD NOT BE CONFIRMED, BASED ON THE LIMITED INFORMATION AVAILABLE, INVESTIGATION RESULTS SUGGEST/INDICATE IN ADDITION TO PROCEDURAL FACTORS (MANIPULATION OF THE DEVICES), PATIENT FACTORS AND OR CO-MORBIDITIES NOT PROVIDED, MAY HAVE CONTRIBUTED TO THE VENTRICULAR PERFORATION. 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. REFERENCE FOR ARTICLE: BARTH S, REENTS W, ZACHER M, KERBER S, DIEGELER A, SCHIEFFER B, SCHREIBER M, LAUER B, KUNTZE T, DAHMER M, HAMM C, HAMM K. MULTI-CENTER PROPENSITY-MATCHED COMPARISON OF TRANSCATHETER AORTIC VALVE IMPLANTATION USING THE ACURATE TA/NEO SELFEXPANDING VERSUS THE SAPIEN 3 BALLOON-EXPANDING PROSTHESIS. EUROINTERVENTION 2019; JAA-609 2019, DOI: 10.4244/EIJ-D-18-01120. THIS IS ONE OF SEVEN MANUFACTURER REPORTS BEING SUBMITTED FOR THIS CASE.

    Description of Event or Problem · 1

    AS REPORTED BY OUR AFFILIATE IN (B)(6) AND THROUGH AN ARTICLE, "MULTI-CENTER PROPENSITY-MATCHED COMPARISON OF TRANSCATHETER AORTIC VALVE IMPLANTATION USING THE ACURATE TA/NEO SELF-EXPANDING VERSUS THE SAPIEN 3 BALLOON-EXPANDING PROSTHESIS" IN THE ABSENCE OF RANDOMIZED DATA, COMPARISON OF THE TRANSAPICAL ACURATE AND TRANSFEMORAL ACURATE NEO PROSTHESES WITH THE SAPIEN 3 PROSTHESES USING PROPENSITY-MATCHING WAS PERFORMED. FROM 2012 TO 2016, 1306 PATIENTS AT 3 GERMAN CENTERS RECEIVED EITHER THE ACURATE/ACURATE NEO PROSTHESES (N=591) OR THE SAPIEN 3 PROSTHESIS (N=715). A VENTRICULAR PERFORATION OCCURRED IN ONE PATIENT. INFORMATION REGARDING THE TIMING OF THE PERFORATION, THE ACTIONS TAKEN, AND THE STATUS OF THE PATIENT WAS NOT PROVIDED. INFORMATION REGARDING THE NATIVE ANNULAR DIAMETER AND DEGREE OF VALVULAR CALCIFICATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22667 EDWARDS COMMANDER DELIVERY SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES COMMANDER DELIVERY SYSTEM UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention