BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THV VALVE UNKNOWN

    MDR report key: 6853090 · Received September 8, 2017

    Report

    Report Number
    2015691-2017-02852
    Event Type
    Injury
    Date Received
    September 8, 2017
    Date of Event
    August 1, 2016
    Report Date
    August 14, 2017
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PMA 130009 (SAPIEN XT) OR 140031 (SAPIEN 3) 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, THE SOURCE AND POSSIBLE CONTRIBUTING FACTORS FOR THE BLEEDING COULD NOT BE DETERMINED. 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.

    Description of Event or Problem · 1

    AS REPORTED BY OUR AFFILIATES IN (B)(6), PER THE ARTICLE "OMISSION OF PREDILATATION IN BALLOON-EXPANDABLE TRANSCATHETER AORTIC VALVE IMPLANTATION: RETROSPECTIVE ANALYSIS IN A LARGE VOLUME CENTER", BETWEEN JANUARY 2011 AND AUGUST 2016, 680 PATIENTS WITH NATIVE AORTIC VALVE STENOSIS WERE SCHEDULED FOR TAVR WITH A SAPIEN XT OR SAPIEN 3 VALVE. 44 PATIENTS HAD LIFE-THREATENING OR MAJOR BLEEDING. NO ADDITIONAL INFORMATION WAS PROVIDED. REFERENCE: HAMM K, REENTS W, ZACHER M, HALBFASS P, KERBER S, DIEGELER A, SCHIEFFER B, BARTH S. OMISSION OF PREDILATATION IN BALLOON-EXPANDABLE TRANSCATHETER AORTIC VALVE IMPLANTATION: RETROSPECTIVE ANALYSIS IN A LARGE VOLUME CENTER. EUROINTERVENSION 2017; JAA-117 2017, DOI: 10.4244/EIJ-D-17-00011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631985 THV VALVE UNKNOWN AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES THV VALVE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention