BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE

    MDR report key: 10802782 · Received November 6, 2020

    Report

    Report Number
    2015691-2020-14280
    Event Type
    Injury
    Date Received
    November 6, 2020
    Date of Event
    September 14, 2020
    Report Date
    October 14, 2020
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE INSTRUCTIONS FOR USE (IFU), DEVICE EMBOLIZATION IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH THE TRANSCATHETER VALVE REPLACEMENT PROCEDURE. THERE ARE MULTIPLE PATIENT AND PROCEDURAL FACTORS THAT ALONE OR IN COMBINATION CAN CAUSE OR CONTRIBUTE TO VALVE EMBOLIZATION, INCLUDING, BUT NOT LIMITED TO, IMPROPER POSITIONING PRIOR TO DEPLOYMENT, POOR IMAGE INTENSIFIER ANGLE, POOR COAXIAL ALIGNMENT OF THE VALVE/DELIVERY SYSTEM, RAPID DEPLOYMENT, MOVEMENT OF THE DELIVERY SYSTEM BY THE OPERATOR, VALVE SIZE MISMATCH, SUBOPTIMAL IMPLANT LOCATION, AND INCOMPLETE FRAME EXPANSION. THE THV TRAINING MANUALS INSTRUCT THE OPERATOR ON PROPER POSITIONING AND DEPLOYMENT OF THE VALVE, INCLUDING ALL PROCEDURAL AND ANATOMICAL CONSIDERATIONS. PHYSICIANS ARE EXTENSIVELY TRAINED BY EDWARDS BEFORE THEY ARE QUALIFIED TO USE THE SAPIEN 3 THV. TRAINING INCLUDES PATIENT SCREENING, DEVICE PREPARATION, APPROACH, DEPLOYMENT, IMAGING, PROCEDURE-SPECIFIC TRAINING MANUALS AND PROCTORED PROCEDURES. THE CORRECT ALIGNMENT AND POSITIONING OF THE DEVICE AT THE POINT OF DEPLOYMENT IS EMPHASIZED AS A KEY FACTOR TO THE PLACEMENT AND FIXATION OF THE DEVICE. OPERATORS ARE ALSO INSTRUCTED TO USE FLUOROSCOPY AS THE PRIMARY METHOD OF VISUALIZATION FOR POSITIONING AND DEPLOYMENT. IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION A DEVICE MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT.  THE CAUSE OF THE VALVE EMBOLIZATION INTO THE AORTA CANNOT BE CONFIRMED, HOWEVER, PER REPORT, PROCEDURAL FACTORS (PACING CAPTURE WAS LOST DURING VALVE DEPLOYMENT) MAY HAVE CONTRIBUTED TO THE EVENT. 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. REFERENCE ARTICLE: KUNAL K. CHAWLA MD, XIANGKE HUANG MD, NEAL HADRO MD, ASHEQUL M. ISLAM MD ¿A NOVEL TECHNIQUE TO MANAGE TRANSCATHETER AORTIC VALVE EMBOLIZATION" WILEY PERIODICALS LLC (SEPTEMBER 2020).

    Description of Event or Problem · 1

    AS REPORTED IN THE MEDICAL ARTICLE, ¿A NOVEL TECHNIQUE TO MANAGE TRANSCATHETER AORTIC VALVE EMBOLIZATION", A CASE OF A (B)(6) MALE WHO WAS PLANNED FOR A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) WITH A 26 MM SAPIEN 3 VALVE FOR THE TREATMENT OF SYMPTOMATIC SEVERE AORTIC STENOSIS. DURING RAPID VENTRICULAR PACING AND IMPLANTATION OF THE TAVR VALVE, THERE WAS A LOSS OF PACING CAPTURE AND SUBSEQUENT EMBOLIZATION OF THE VALVE INTO THE AORTIC ARCH. RETRIEVAL OF THE EMBOLIZED VALVE WAS ATTEMPTED UNSUCCESSFULLY USING SEVERAL TECHNIQUES. FINALLY, A NON EDWARDS VALVE WAS IMPLANTED TO SECURE THE EMBOLIZED VALVE IN THE AORTIC ARCH WITHOUT COMPROMISING THE BRANCH VESSELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1266996 EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9600TFX26A

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention