BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS EXPANDABLE SHEAT SET, 29MM

    MDR report key: 4200236 · Received October 24, 2014

    Report

    Report Number
    2015691-2014-02510
    Event Type
    Injury
    Date Received
    October 24, 2014
    Date of Event
    October 2, 2014
    Report Date
    October 2, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P130009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), CARDIOVASCULAR COMPLICATIONS, INCLUDING PERFORATION OR DISSECTION OF VESSELS WHICH MAY REQUIRE INTERVENTION, ARE POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE. IN THIS CASE, PER REPORT, PROCEDURAL FACTORS (DEVICE MANIPULATION) RESULTED IN A DISSECTION OF THE ACCESS VESSEL. 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

    A 3 DAY POST PROCEDURE TTE REVEALED NORMAL LV SYSTOLIC FUNCTION WITH AN EF OF 65-70%. THERE WAS VERY MILD PARAVALVULAR LEAK (PVL) AND NO HEMODYNAMICALLY SIGNIFICANT STENOSIS. THE PEAK GRADIENT ACROSS THE AV WAS 25.8MMHG (MEAN 13) AND AVA WAS 1.37CM2; NO PERICARDIAL EFFUSION WAS NOTED. THE DEATH WAS ATTRIBUTED TO ACUTE KIDNEY INJURY (AKI) WITH LACTIC ACIDOSIS AND HYPERKALEMIA SECONDARY TO SHOCK.

    Description of Event or Problem · 1

    DURING A TAVR PROCEDURE VIA SUBCLAVIAN APPROACH, A DISSECTION OCCURRED IN THE ACCESS VESSEL. INITIALLY A CONDUIT WAS SEWN IN. THE SHEATH WAS THEN INSERTED INTO THE VESSEL. A MAYO STAND WAS USED TO SUPPORT THE LENGTH OF THE SHEATH OUTSIDE OF THE VESSEL, THUS THE SHEATH WAS SECURED TO THE MAYO STAND WITH SUTURE. AT SOME POINT DURING THE PROCEDURE, AS THE PROCEDURE TABLE WITH THE PATIENT WAS PANNED, THE MAYO STAND WAS NOT MOVED ALONG WITH THE TABLE. THE BACK AND FORTH ACTION OF THE SHEATH RESULTED IN A DISSECTION OF THE ACCESS VESSEL. THE PATIENT¿S BLOOD PRESSURE DROPPED AND CARDIOPULMONARY BYPASS WAS INITIATED. THE SUBCLAVIAN ARTERY WAS REPAIRED SURGICALLY AND THE PATIENT WAS STABILIZED. THE PROCEDURE WAS CONVERTED TO TAO ACCESS AND COMPLETED SUCCESSFULLY. THE NEXT DAY THE PATIENT WAS DOING WELL. AS REPORTED, THE PATIENT DIED 3 DAYS POST PROCEDURE. AS PER POST PROCEDURE DISCUSSION, THE PATIENT LOST A LOT OF BLOOD DURING THE PROCEDURE AND HE WAS ELDERLY WITH COMORBIDITIES THAT MAY HAVE CONTRIBUTED TO HIS DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679797 EDWARDS EXPANDABLE SHEAT SET, 29MM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 920ES29

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention