BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDOPLEGE CORONARY SINUS CATHETER

    MDR report key: 2451724 · Received February 14, 2012

    Report

    Report Number
    3008500478-2012-00202
    Event Type
    Death
    Date Received
    February 14, 2012
    Date of Event
    December 14, 2011
    Report Date
    February 13, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DWF
    PMA / PMN Number
    K961270
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS DISCARDED BY THE HOSPITAL. INITIAL REPORT ARRIVED VIA A MEDWATCH ((B)(4)). SINCE A LOT NUMBER IS UNKNOWN, A DEVICE HISTORY REVIEW CANNOT BE OBTAINED. THE PRODUCT HAS BEEN DISCARDED BY THE HOSPITAL AND THE ROOT CAUSE CANNOT BE DETERMINED FOR THIS EVENT. A CAPA WILL NOT BE INITIATED FOR THIS EVENT. THIS INFORMATION WILL BE INCLUDED IN TRENDING AND FUTURE CAPA DETERMINATION.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A MEDWATCH THAT A (B)(6) MALE WAS UNDERGOING HIGH RISK CARDIAC SURGERY, 15 YRS AFTER HIS PREVIOUS CABG PROCEDURE. THE MD CHOSE A MINIMALLY INVASIVE AORTIC VALVE REPLACEMENT. THIS TECHNIQUE WAS STATED AS BEING WELL ESTABLISHED IN THE LITERATURE FROM MULTIPLE SITES. AS PART OF THE PROCEDURE, A SHEATHED INTERNAL JUGULAR DIRECTED CORONARY SINUS CARDIOPLEGIA CATHETER IS PLACED TO FACILITATE MYOCARDIAL PROTECTION. THE PLACEMENT BY THE ANESTHESIOLOGIST WAS DIFFICULT AND THE PATIENT WAS HYPOTENSIVE PRIOR TO INCISION AND REQUIRED A BRIEF PERIOD OF CPR. AT STERNOTOMY, THERE WAS A LACERATION OF THE BRACHIOCEPHALIC VEIN. THEY REPAIRED THE LACERATION BUT COULD NOT SEE IT WELL. IT BLED AGAIN. INTRAOPERATIVE STENT PLACEMENT CONTROLLED THE BLEEDING EVENTUALLY BUT THE PATIENT DIED DUE TO THE PROLONGED TIME ON CARDIOPULMONARY BYPASS. THE MD BELIEVED HIS CAUSE OF DEATH WAS THE BRACHIOCEPHALIC VEIN LACERATION DUE TO THE ENDOPLEGE. THE ANESTHESIOLOGIST COMMENTED THE INTRODUCER FOR THE CORONARY SINUS VENT CATHETER IS LARGER THAN THE ONE WE USE FOR OUR TYPICAL SWAN GANS PA CATHETERS. GIVEN THE OUTCOME IN THIS CASE, IT IS NOT UNREASONABLE TO REASSESS THE RISKS OF USING THIS LARGER INTRODUCER DESIGN AND IT DILATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPLEGE CORONARY SINUS CATHETER CORONARY SINUS CATHETER DWF EDWARDS LIFESCIENCES EP UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death