BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 6726435 · Received July 19, 2017

    Report

    Report Number
    2015691-2017-02118
    Event Type
    Injury
    Date Received
    July 19, 2017
    Date of Event
    January 1, 2016
    Report Date
    June 30, 2017
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REFERENCE RELATED MANUFACTURING REPORT NUMBERS: 2015691-2017-02111, 2015691-2017-02112, 2015691-2017-02113, 2015691-2017-02114, 2015691-2017-02116, AND 2015691-2017-02119.

    Additional Manufacturer Narrative · 1

    A POST PROCEDURAL BLEED/ HEMORRHAGE WITHOUT AN OBVIOUS SOURCE OF BLEEDING IS A RARE BUT POTENTIALLY LIFE THREATENING COMPLICATION OF CORONARY/CARDIAC INTERVENTIONAL PROCEDURES, AND TENDS TO OCCUR MORE FREQUENTLY IN THE PRESENCE OF MORE AGGRESSIVE ANTICOAGULATION REGIMENS. POSSIBLE SOURCES INCLUDE PUNCTURE OF THE FEMORAL ARTERY ABOVE THE INGUINAL LIGAMENT AND ABOVE THE INFERIOR EPIGASTRIC ARTERY, ALLOWING THE RESULTANT BLEEDING TO EXTEND INTO THE RETROPERITONEAL SPACE, OR INADVERTENT TRAUMA OR PERFORATION OF THE ANNULAR STRUCTURE OR VENTRICLES DURING THE PROCEDURE. THIS TYPE OF BLEEDING MAY NOT BE RECOGNIZED UNTIL THE POST PROCEDURAL PERIOD. IN THIS CASE, GIVEN THE LIMITED INFORMATION AVAILABLE (ARTICLE PATIENTS), THE SOURCE AND POSSIBLE CONTRIBUTING FACTORS COULD NOT BE DETERMINED. 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. THE TYPE OF THV VALVE IS UNKNOWN; HOWEVER, THESE ARE THE POSSIBLE 510K NUMBER FOR SAPIEN, SAPIEN XT AND SAPIEN 3: P100041, P130009, AND P140031 RUCK, A. (2016). PERCUTANEOUS VALVE REGISTRY. SWEDEHEART, 266-280.

    Description of Event or Problem · 1

    AS REPORTED IN THE (B)(6) REGISTRY 2016, TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) HAS BEEN PERFORMED IN (B)(6) SINCE 2008. AS PER ARTICLE, IN 2016, A MAJOR BLEEDING COMPLICATIONS HAD OCCURRED IN 15 CASES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506317 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES SAPIEN VALVE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention