BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE UNKNOWN

    MDR report key: 10427946 · Received August 19, 2020

    Report

    Report Number
    2015691-2020-13210
    Event Type
    Injury
    Date Received
    August 19, 2020
    Date of Event
    November 28, 2019
    Report Date
    July 24, 2020
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IN THIS CASE, THE VALVE MODEL NUMBER AND IMPLANT DATE IS UNKNOWN.  VALVE IN VALVE IS PERFORMED AS AN INTERVENTION FOR SEVERE OR CLINICALLY SIGNIFICANT PVL, CENTRAL LEAK, OR VALVES DEPLOYED TOO AORTIC/TOO VENTRICULAR.  THIS INTERVENTION IS PERFORMED TO TREAT SERIOUS INJURY AND/OR PREVENT PERMANENT IMPAIRMENT.  IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION A DEVICE MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT.  THE CAUSES OF THE VALVE IN VALVE PROCEDURE COULD NOT BE DETERMINED WITH THE LIMITED INFORMATION PROVIDED.  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 NAY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS MONTHLY REVIEW.  NO CORRECTIVE OR PREVENTIVE ACTIONS ARE REQUIRED AT THIS TIME. REFERENCE ARTICLE: SU JIN LIM , MD1 , HYUN JUNG KOO , MD, PHD1 , SEUNG CHAI JUNG , MD, PHD1 , DO-YOON KANG , MD, PHD2 , JUNG-MIN AHN , MD, PHD2 , DUK-WOO PARK , MD, PHD2 , SEUNG-JUNG PARK , MD, PHD2 , DONG HYUN YANG , MD, PHD1 , AND JOON-WON KANG , MD, PHD , ¿SINUS OF VALSALVA THROMBOSIS DETECTED ON COMPUTED TOMOGRAPHY AFTER TRANSCATHETER AORTIC VALVE REPLACEMENT¿ (KOREAN CIRCULATION JOURNAL, 2019).

    Description of Event or Problem · 1

    AS REPORTED FROM OUR AFFILIATES IN (B)(6), PER MEDICAL ARTICLE ¿SINUS OF VALSALVA THROMBOSIS DETECTED ON COMPUTED TOMOGRAPHY AFTER TRANSCATHETER AORTIC VALVE REPLACEMENT¿ A STUDY BETWEEN MARCH 2011 AND AUG 2019, 192 PATIENTS UNDERWENT CARDIAC CT AFTER TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. APPROXIMATELY 8 YEARS POST TAVR WITH A SAPIEN VALVE, ONE PATIENT UNDERWENT A VALVE-IN-VALVE PROCEDURE.  THE REASON FOR THE VALVE IN VALVE IS UNKNOWN.  NO FURTHER INFORMATION CAN BE ACHIEVED FROM THE SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    888900 EDWARDS SAPIEN TRANSCATHETER HEART VALVE UNKNOWN AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES SAPIEN VALVE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention