BEUDAMED
    FDA Adverse Event Death Summary report: N

    EVOLUT PRO TRANSCATHETER AORTIC VALVE

    MDR report key: 10325537 · Received July 27, 2020

    Report

    Report Number
    2025587-2020-02346
    Event Type
    Death
    Date Received
    July 27, 2020
    Date of Event
    July 1, 2020
    Report Date
    October 8, 2020
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CONCLUSION: THE VALVE REMAINS IMPLANTED; THEREFORE NO PRODUCT ANALYSIS COULD BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD AND FRAME RECORD FOR THE VALVE FOUND IT WAS BUILT TO SPECIFICATION AND MET ALL INSPECTION AND ACCEPTANCE CRITERIA. NO ISSUES WERE NOTED THAT WOULD HAVE IMPACTED THIS EVENT. FLUOROSCOPIC IMAGES PROVIDED CONFIRMED THE VALVE WAS LOADED CORRECTLY. THE IMAGES CONFIRMED THE VALVE WAS INITIALLY POSITIONED SHALLOW, THEN POSITIONED AGAIN IN A GOOD DEPTH AT WHICH TIME IT WAS FULLY DEPLOYED. CINES SHOWED NO CORONARY FLOW IN THE RIGHT CORONARY ARTERY AND A SNARE THAT WAS INTRODUCED TO REPOSITION THE VALVE UP AND AWAY FROM THE CORONARIES. THE USE OF A SNARE TO REPOSITION THE VALVE AFTER DEPLOYMENT IS COMPLETE IS NOT RECOMMENDED PER THE INSTRUCTIONS FOR USE (IFU). THE VALVE WAS THEN LEFT IMPLANTED IN THE ASCENDING AORTA OUT OF THE WAY OF THE CORONARIES. THE NEXT CINES SHOW THE RIGHT CORONARY ARTERY, HOWEVER, THERE IS NO HEART FUNCTION OR MOVEMENT. FOLLOW UP INFORMATION RECEIVED STATED THAT THE VALVE WAS INITIALLY IMPLANTED AT AROUND 0MM, WITH THE FINAL DEPTH AT 1MM. PER MEDTRONIC¿S BEST PRACTICES, THE VALVE DEPLOYMENT SHOULD BE STARTED AT 0MM, ADJUSTING TO TARGET DEPTH OF 3MM. IN ADDITION, THE EVENT DESCRIPTION STATED THAT THE VALVE HAD CONTINUED TO EXPAND 15 MINUTES AFTER DEPLOYMENT. BASED ON THE ANGIOGRAM AND THE INFORMATION PROVIDED, THE POTENTIAL CONTRIBUTING CAUSE MAY HAVE BEEN LACK OF GOOD ANNULAR CONTACT, (U NDER-EXPANDED VALVE), BETWEEN THE VALVE AND THE PATIENT¿S ANNULUS. THIS LIKELY RESULTED IN VALVE MOVEMENT, LED TO A CORONARY OCCLUSION AND RESULTED IN DEATH. IN INSTANCES WHERE THE VALVE WAS NOT FULLY EXPANDED, THE INSTRUCTIONS FOR USE (IFU) RECOMMENDS PERFORMING A POST IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV). PER THE IFU, IN THE EVENT THAT VALVE FUNCTION OR SEALING IS IMPAIRED DUE TO EXCESSIVE CALCIFICATION OR INCOMPLETE EXPANSION, A POSTIMPLANT BALLOON DILATATION OF THE VALVE MAY IMPROVE VALVE FUNCTION AND SEALING. IT WAS REPORTED THAT A POST BAV WAS NOT PERFORMED. THIS EVENT DOES NOT INDICATE DEVICE MISUSE OR MALFUNCTION. SECTION E: UPDATED PHONE NUMBER SECTION H.6 UPDATED DEVICE, METHOD, RESULTS AND CONCLUSION CODES. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED THAT FOLLOWING THE USE OF THE CLOSURE DEVICE, WHILE THE PATIENT WAS BEING TRANSFERRED TO THE STRETCHER THE PATIENT COLLAPSED, IT WAS NOT IMMEDIATELY DURING THE VALVE RELEASE. IT WAS REPORTED THAT THE INITIAL VALVE IMPLANT DEPTH WAS APPROXIMATELY 0 MILLIMETER (MM) AND THE FINAL IMPLANT DEPTH WAS -1 MM. A POST BALLOON AORTIC VALVULOPLASTY (BAV) WAS NOT PERFORMED. UPDATED EVENT - DESCRIPTION OF THE EVENT. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. 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

    PRODUCT ANALYSIS: NO PRODUCT WAS RETURNED. CONCLUSION: WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY 15 MINUTES AFTER THE DEPLOYMENT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, IT WAS REPORTED THAT THE VALVE SEEMED TO HAVE EXPANDED, OBSTRUCTING THE CORONARY ARTERIES. IT WAS REPORTED THAT THE VALVE EXPANDED DUE ITS NATURE TO EXPAND IN BODY TEMPERATURE AND THAT IT WAS NOT UNDER-EXPANDED UPON DEPLOYMENT. THERE WAS AN ATTEMPT TO CANNULATE THE RIGHT CORONARY ARTERY (RCA). THE DECISION WAS THEN MADE TO SNARE THE VALVE TO THE ASCENDING AORTA. CARDIOPULMONARY RESUSCITATION (CPR) WAS ADMINISTERED. THE PATIENT THEN COLLAPSED WHILE MOVING OFF THE TABLE, AND LATER DIED ON THE TABLE. THE CAUSE OF DEATH WAS REPORTED TO BE OCCLUSION OF THE CORONARY ARTERIES. PER THE IMPLANTING PHYSICIAN, THE VALVE CAUSED THE PATIENT DEATH. AN AUTOPSY WAS PERFORMED. IT WAS REPORTED THAT THE AUTOPSY FOUND NO SIGNIFICANT PATHOLOGY EXCEPT FOR THE VALVE IN THE ASCENDING AORTA AND SOME DEBRIS IN THE RCA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792468 EVOLUT PRO TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION EVOLUTPRO-29

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death