BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

    MDR report key: 7749710 · Received August 3, 2018

    Report

    Report Number
    2015691-2018-03204
    Event Type
    Injury
    Date Received
    August 3, 2018
    Date of Event
    November 2, 2011
    Report Date
    July 11, 2018
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    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 · 1

    THE EXACT DATES OF THE EVENTS ARE UNKNOWN. THE TYPE OF THV VALVE IS UNKNOWN; HOWEVER, THESE ARE THE POSSIBLE PMA NUMBERS FOR SAPIEN, SAPIEN XT AND SAPIEN 3: P110021, P130009, AND P140031. THE VALVES WERE NOT RETURNED TO EDWARDS LIFESCIENCES AS THEY REMAIN IMPLANTED IN THE PATIENT¿S. WITH SUCH LIMITED INFORMATION, THE REASON FOR THE SECOND VALVE DEPLOYMENT ON EACH OF THESE CASES CANNOT BE DETERMINED. IT IS POSSIBLE THAT, IN ADDITION TO THE PROCEDURE ITSELF, UNKNOWN PATIENT FACTORS MAY HAVE CONTRIBUTED TO THESE EVENTS. 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. BIBLIOGRAPHY: D. SCHEWEL, ET AL., CORRELATION OF TRICUSPID REGURGITATION AND NEW PACEMAKER IMPLANTATION IN PATIENTS UNDERGOING TRANSCATHETER AORTIC VALVE IMPLANTATI..., INT J CARDIOL (2017), HTTPS://DOI.ORG/10.1016/J.IJCARD.2018.03.030.

    Description of Event or Problem · 1

    AS REPORTED BY THE EDWARDS AFFILIATE IN (B)(4), A JOURNAL ARTICLE TITLED, "CORRELATION OF TRICUSPID REGURGITATION AND NEW PACEMAKER IMPLANTATION IN PATIENTS UNDERGOING TRANSCATHETER AORTIC VALVE IMPLANTATION" REPORTED THAT POST TAVR PROCEDURE, 6 PATIENT¿S REQUIRED A SECOND VALVE (EXACT DATES AND REASONS ARE UNKNOWN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589958 AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention