BEUDAMED
    FDA Adverse Event Death Summary report: N

    COREVALVE

    MDR report key: 4027158 · Received August 21, 2014

    Report

    Report Number
    2025587-2014-00589
    Event Type
    Death
    Date Received
    August 21, 2014
    Date of Event
    July 28, 2014
    Report Date
    January 27, 2015
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE DEVICE HISTORY RECORD FOR THE VALVE WAS REVIEWED AND SHOWED THAT THIS DEVICE MET ALL MANUFACTURING SPECIFICATIONS FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. HYPOTENSION IS AN EFFECT THAT IS HIGHLY DEPENDENT ON THE PATIENT'S PRE-PROCEDURAL CONDITION AND CAN OCCUR DESPITE A NORMALLY-FUNCTIONING DEVICE OR MODEL IMPLANT PROCEDURE. IN THIS CASE, IT WAS BELIEVED TO BE RELATED TO THE OCCLUSION OF THE LEFT CORONARY ARTERY. THE OCCLUSION WAS REPORTEDLY CAUSED BY THE FREESTYLE BIOPROSTHESIS LEAFLET BEING PUSHED INTO THE LEFT MAIN CORONARY ARTERY. DESPITE MOVING THE COREVALVE FRAME, ACCESS COULD NOT BE REGAINED TO THE ARTERY. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED A MYOCARDIAL INFARCTION. HYPOTENSION, OCCLUSIONS, AND MYOCARDIAL INFARCTIONS ARE ALL KNOWN POTENTIAL ADVERSE EFFECTS. THE REPORT OF PATIENT EXPIRATION DURING THE PROCEDURE WAS ASCERTAINED TO BE RELATED TO THE PROCEDURE. AS NEITHER AN AUTOPSY NOR AN EXPLANT WAS PERFORMED, A CONCLUSIVE ASSESSMENT OF THE RELATIONSHIP BETWEEN THE EVENT AND THE DEVICE COULD NOT BE REACHED. A PROCEDURE- OR VALVE-RELATED DEATH IS AN INHERENT RISK WHEN THE PATIENT CONDITION IS SUCH THAT A PAV IS NEEDED TO SUSTAIN CARDIAC FUNCTION, AND IT CAN OCCUR DESPITE AN IDEAL IMPLANT PROCEDURE OR THE DEVICE FUNCTIONALITY. NO ALLEGATIONS WERE MADE AGAINST THE DEVICE, AND THERE WAS NO INDICATION THAT A MALFUNCTION OR MISUSE CONTRIBUTED TO THE REPORTED EVENTS.

    Additional Manufacturer Narrative · 1

    AN AUTOPSY WAS NOT PERFORMED, AND THE DEVICE REMAINED IMPLANTED. THERE WAS NO ALLEGATION OF A MALFUNCTION OF THIS DEVICE OR ITS DELIVERY CATHETER SYSTEM. A SUPPLEMENTAL REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETED. A SEPARATE REPORT WILL BE FILED ON THE AORTIC ROOT BIOPROSTHESIS. (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT THIS TRANSCATHETER BIOPROSTHETIC VALVE WAS IMPLANTED VALVE-IN-VALVE INTO AN AORTIC ROOT BIOPROSTHESIS THAT HAD BEEN IMPLANTED FOR APPROXIMATELY 8.5 YEARS. DURING PREPARATIONS TO IMPLANT THIS DEVICE, DUE TO A LOW TAKE-OFF OF THE LEFT CORONARY, THE LEFT CORONARY WAS PRE-WIRED FOR PLACEMENT OF AN UNDEPLOYED CORONARY STENT INTO THE LEFT MAIN CORONARY ARTERY. THIS DEVICE WAS THEN IMPLANTED WITH THE CORONARY WIRE AND STENT LEFT IN PLACE. AFTER ASSESSMENT OF HEMODYNAMICS, THE VALVE WAS DETERMINED TO BE IN GOOD POSITION AND WITH FLOW TO THE LEFT CORONARY. IT WAS DECIDED TO REMOVE THE UNDEPLOYED STENT AND WIRE. A FEW MINUTES LATER THE PATIENT EXHIBITED HYPOTENSION, AND CHEST COMPRESSIONS/CARDIOPULMONARY RESUSCITATION WERE INITIATED. IT WAS DETERMINED THAT THE LEFT CORONARY ARTERY WAS OCCLUDED. AN ATTEMPT TO RE-CROSS INTO THE LEFT CORONARY OSTIUM WAS UNSUCCESSFUL. IT WAS THEN DECIDED TO INFLATE A 25MM BALLOON INSIDE THIS DEVICE¿S FRAME AND PULL IT UP AND OUT OF THE ANNULUS. THE FRAME WAS SUCCESSFULLY PULLED UP BUT ACCESS TO THE LEFT CORONARY ARTERY COULD NOT BE OBTAINED. SUPPORT WAS EVENTUALLY DISCONTINUED, AND THE PATIENT EXPIRED. IT WAS SUBSEQUENTLY DETERMINED THAT DURING THE IMPLANT PROCEDURE, THE FRAME OF THIS DEVICE HAD PUSHED A LEAFLET OF THE CHRONIC REPLACEMENT VALVE UP TO WHERE IT HAD OCCLUDED THE LEFT MAIN CORONARY ARTERY, AND THAT THE PATIENT ALSO HAD EXPERIENCED A MYOCARDIAL INFARCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507185 COREVALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION MCS-P3-640

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR Death| R