BEUDAMED
    FDA Adverse Event Death Summary report: N

    EVOLUT R TRANSCATHETER AORTIC VALVE

    MDR report key: 6125969 · Received November 23, 2016

    Report

    Report Number
    2025587-2016-01853
    Event Type
    Death
    Date Received
    November 23, 2016
    Date of Event
    November 3, 2016
    Report Date
    July 6, 2017
    Manufacturer
    HEART VALVES SANTA ANA
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS PRODUCT MET ALL MANUFACTURING SPECIFICATIONS FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. POTENTIAL FACTORS THAT CAN INFLUENCE DISLODGEMENT INCLUDE TENSION APPLIED ON THE DELIVERY CATHETER SYSTEM (DCS) DURING POSITIONING, CALCIFICATION LEVELS AND COMPLIANCE OF THE NATIVE ANATOMY, AND USER TECHNIQUE. IN THIS CASE, IT WAS REPORTED THAT THE NOSE CONE OF THE DCS CAUGHT ON THE VALVE AND DISLODGED IT INTO THE SINUSES. DISLODGE EVENTS ARE TYPICALLY NOT RELATED TO A DEVICE MALFUNCTION. CORONARY OCCLUSION AND CARDIAC ARREST ARE LISTED IN THE DEVICE INSTRUCTIONS FOR USE (IFU) AS POTENTIAL PATIENT ADVERSE EVENTS. IT WAS REPORTED THAT FOLLOWING THE IMPLANT PROCEDURE THERE WERE WITH NO SIGNS OF CORONARY OCCLUSION. CORONARY OCCLUSION CAN BE RELATED TO MULTIPLE FACTORS SUCH AS PATIENT ANATOMY, IMPLANT POSITION AND IMPLANT TECHNIQUE. IT WAS REPORTED THAT AFTER THE VALVE DISLODGED, A DECISION WAS MADE TO LEAVE THE VALVE IMPLANTED INTO THE SINUSES, BEING IN A SUBOPTIMAL POSITION. IT IS UNCLEAR IF THE OCCLUSION WAS DUE TO THE SUBOPTIMAL POSITION OF THE VALVE, AS IT WAS INITIALLY REPORTED THAT THE PHYSICIAN WAS CONCERNED TO PULL THE VALVE BACK UP USING A SNARE AS THE PATIENT HAD A PREVIOUS CORONARY ARTERY BYPASS GRAFT (CABG) WITH PATENT GRAFTS. THERE WERE NO CINES/IMAGES RECEIVED OF THE PATIENT PROCEDURE SO MEDTRONIC IS UNABLE TO CONCLUSIVELY DETERMINE THE CAUSE FOR THE REPORTED CORONARY OCCLUSION. THE REPORT OF PATIENT DEATH APPROXIMATELY ONE HOUR POST IMPLANT WAS ASCERTAINED TO BE RELATED TO THE LEFT CORONARY ARTERY (LCA) OCCLUSION. A PROCEDURE - OR VALVE- RELATED DEATH IS AN INHERENT RISK WHEN THE PATIENT CONDITION IS SUCH THAT A TRANSCATHETER AORTIC VALVE (TAV) IS NEEDED TO SUSTAIN CARDIAC FUNCTION, AND IT CAN OCCUR DESPITE AN IDEAL IMPLANT PROCEDURE OR DEVICE FUNCTIONALITY. THIS EVENT DOES NOT INDICATE DEVICE MISUSE OR MALFUNCTION. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    WITHOUT RETURN OF THE DEVICE, A CONCLUSIVE CAUSE CANNOT BE DETERMINED. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE NOSE CONE OF THE DELIVERY CATHETER SYSTEM (DCS) CAUGHT ON THE VALVE AND IT DISLODGED INTO THE SINUSES. THE VALVE REMAINED IN PLACE AND A SECOND VALVE WAS SUCCESSFULLY IMPLANTED. ONE HOUR FOLLOWING THE PROCEDURE, THE PATIENT REPORTED CHEST PAINS AND ARRESTED. CARDIOPULMONARY RESUSCITATION (CPR) WAS PERFORMED BUT WAS UNSUCCESSFUL AND THE PATIENT EXPIRED. AN AUTOPSY WAS PERFORMED. THE PHYSICIAN REPORTED THAT THE FIRST VALVE HAD OCCLUDED THE LEFT CORONARY ARTERY AND THE PATIENT'S DEPENDENCY ON THAT ARTERY HAD BEEN UNDERESTIMATED DUE TO THE CORONARY ARTERY BYPASS GRAFT (CABG) AND PATENT GRAFTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774836 EVOLUT R TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT HEART VALVES SANTA ANA EVOLUTR-26-US

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death| R DCS LOT#0008091766