BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS COMMANDER DELIVERY SYSTEM

    MDR report key: 13023994 · Received December 17, 2021

    Report

    Report Number
    2015691-2021-06880
    Event Type
    Injury
    Date Received
    December 17, 2021
    Date of Event
    November 22, 2021
    Report Date
    December 22, 2021
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS ONE OF TWO MANUFACTURER REPORTS BEING SUBMITTED FOR THIS CASE. PLEASE REFERENCE RELATED MANUFACTURER REPORT NO: (B)(4). (MDR# 2021-20337-01). PER THE INSTRUCTIONS FOR USE (IFU) CARDIOVASCULAR INJURY, SUCH AS PERFORATION OR DAMAGE (DISSECTION) OF VESSELS, VENTRICLE, MYOCARDIUM, OR VALVULAR STRUCTURES, IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH THE TAVR PROCEDURE. ACCESS SITE INJURIES, INCLUDING DISSECTION OF THE AORTIC WALL DURING THE TRANSAORTIC APPROACH, ARE A WELL-RECOGNIZED COMPLICATION OF THE TAVR PROCEDURE IN THIS ELDERLY POPULATION WITH MULTIPLE CO-MORBIDITIES. PHYSICIANS ARE EXTENSIVELY TRAINED BY EDWARDS BEFORE THEY ARE QUALIFIED TO USE THE TRANSCATHETER HEART VALVE (THV). TRAINING INCLUDES PATIENT SCREENING, DEVICE PREPARATION, APPROACH, DEPLOYMENT, IMAGING, PROCEDURE-SPECIFIC TRAINING MANUALS AND PROCTORED PROCEDURES. THE THV TRAINING MANUALS INSTRUCT THE USER TO DETERMINE WITH CT IF THE PLANNED AORTIC ACCESS SITE IS FREE OF CALCIFICATION, ALLOWS THE SHEATH TO BE PLACED IN A STRAIGHT LINE, AND LEAVES ADEQUATE ROOM BETWEEN THE TIP OF THE SHEATH AND NATIVE AORTIC VALVE ANNULUS TO ALLOW FULL BALLOON EXPANSION. CONSIDERATIONS FOR APPROACH (PARTIAL J-STERNOTOMY OR RIGHT MINI-THORACOTOMY), ACCESS AND STABILIZATION OF THE SITE ARE ALSO PROVIDED IN THE TRAINING. IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION A DEVICE MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT. INVESTIGATION RESULTS SUGGEST/INDICATE THAT THE EXACT CAUSE OF THE VESSEL INJURY AT THE ACCESS SITE CANNOT BE CONFIRMED. INVESTIGATION SUGGEST IT WAS POSSIBLY DUE TO PROCEDURAL FACTORS (DEVICE MANIPULATION) AND/OR PATIENT FACTORS (I.E., CALCIFICATION OF THE ACCESS VESSEL) THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT EVENT. 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. NA.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING REPORT FIELDS HAVE BEEN UPDATED DUE TO ADDITIONAL INFORMATION RECEIVED: G3 THIS IS ONE OF TWO MANUFACTURER REPORTS BEING SUBMITTED FOR THIS CASE. PLEASE REFERENCE RELATED MANUFACTURER REPORT NO: 2015691-2021-06880 (MDR# 2021-20337-01).

    Description of Event or Problem · 0

    AS REPORTED BY AN EDWARDS LIFESCIENCES AFFILIATE IN (B)(6), DURING A TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) IN THE NATIVE AORTIC POSITION, VENTRICULAR PERFORATION HAPPENED. PERICARDIAL EFFUSION WAS OBSERVED ON TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE), AND PERICARDIAL DRAINAGE WAS PERFORMED. THERE WAS MASSIVE BLEEDING, AND THE CHEST WAS OPENED TO SUTURE THE ANTERIOR WALL OF THE BLEEDING POINT. THE BYPASS WAS CHANGED TO INTRA-AORTIC BALLOON PUMPING (IABP), AND PATIENT LEFT THE OPERATING ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1923560 EDWARDS COMMANDER DELIVERY SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9600LDS23J 63742484

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Female Required Intervention