BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 12005946 · Received June 15, 2021

    Report

    Report Number
    2025587-2021-01902
    Event Type
    Death
    Date Received
    June 15, 2021
    Date of Event
    October 15, 2020
    Report Date
    July 13, 2021
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE PHYSICIAN/AUTHOR(S) REGARDING TWO PATIENT DEATHS FOLLOWING MEDTRONIC VALVE IMPLANT. ONE PATIENT (MAIN ARTICLE, FIGURE 1) IMPLANTED WITH A MEDTRONIC VALVE EXPERIENCED A CORONARY OBSTRUCTION 24 HOURS POST-IMPLANT WHICH REQUIRED REVASCULARIZATION VIA PERCUTANEOUS CORONARY ANGIOPLASTY. POST-INTERVENTION THE PATIENT EXPERIENCED A STROKE AND MYOCARDIAL INFARCTION (MI). THE FAMILY AGREED TO CEASE LIFE-EXTENDING MEASURES, AND THE PATIENT SUBSEQUENTLY DIED DUE TO A CARDIOVASCULAR DEATH ADJUDICATED AS ¿RELATED TO PROCEDURE AND PROBABLY RELATED TO DEVICE¿. A SECOND PATIENT (SUPPLEMENT DATA, TABLE X) DIED 11 DAYS POST-IMPLANT DUE TO MULTI-ORGAN FAILURE IN THE CONTEXT OF SEPSIS. AN AUTOPSY FOUND EVIDENCE OF THROMBI OF THE VALVE. THE DEATH WAS ADJUDICATED AS ¿RELATED TO PROCEDURE AND UNLIKELY RELATED TO THE DEVICE¿. NO FURTHER DETAILS WERE PROVIDED ON THESE DEATHS. NO UNIQUE DEVICE IDENTIFIER NUMBERS WERE PROVIDED. NO EXPLANTED VALVES WERE AVAILABLE FOR RETURN TO MEDTRONIC.

    Additional Manufacturer Narrative · 1

    CITATION: TAMBURINO ET AL. COMPARISON OF SELF-EXPANDING BIOPROSTHESES FOR TRANSCATHETER AORTIC VALVE REPLACEMENT IN PATIENTS WITH SYMPTOMATIC SEVERE AORTIC STENOSIS: SCOPE 2 RANDOMIZED CLINICAL TRIAL. CIRCULATION. 2020 DEC 22;142(25):2431-2442. DOI: 10.1161/CIRCULATIONAHA.120.051547. EPUB 2020 OCT 15. EARLIEST DATE OF PUBLISH USED FOR DATE OF EVENT AND DATE OF DEATH. MEDTRONIC PRODUCTS REFERENCED: EVOLUT R AND EVOLUT PRO. EARLIEST APPROVED PRODUCT USED FOR PRODUCT CODE AND PMA#. NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED. WITHOUT RETURN OF THE PRODUCT NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATIONS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REGARDING A COMPARISON OF SELF-EXPANDING BIOPROSTHESES FOR TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) IN PATIENTS WITH SYMPTOMATIC SEVERE AORTIC STENOSIS. ALL DATA WERE COLLECTED FROM MULTIPLE CENTERS BETWEEN APRIL 2017 AND APRIL 2019. THE STUDY POPULATION INCLUDED 796 PATIENTS (PREDOMINANTLY FEMALE, MEAN AGE 83.2 YEARS), 398 OF WHICH WERE IMPLANTED WITH A MEDTRONIC EVOLUT R OR EVOLUT PRO BIOPROSTHETIC VALVE (UNIQUE DEVICE IDENTIFIER NUMBERS NOT PROVIDED). AMONG ALL PATIENTS 2.8% DEATHS OCCURRED AT 30 DAYS AND 8.4% DEATHS OCCURRED AT 1-YEAR FOLLOW-UP. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT WAS NOT DIRECTLY ASSOCIATED WITH THESE DEATHS. HOWEVER, EVOLUT R VALVES WERE DIRECTLY ASSOCIATED WITH TWO DEATHS: A PROCEDURAL DEATH WITHOUT CAUSE OR FURTHER DETAILS PROVIDED (MAIN ARTICLE), AND A DEATH AT 11 DAYS POSTIMPLANT DUE TO MULTI-ORGAN FAILURE IN THE CONTEXT OF SEPSIS WITH AN AUTOPSY REPORT OF THROMBI OF THE AORTIC VALVE PROSTHESIS (SUPPLEMENT DATA, TABLE X). NO FURTHER DETAILS WERE PROVIDED ON THESE TWO DEATHS. SPECIFIC TO EVOLUT R VALVES ADVERSE EVENTS INCLUDED: HEMODYNAMIC INSTABILITY, CARDIAC TAMPONADE, ANNULAR RUPTURE, CONVERSION TO OPEN SURGERY, STROKE, CONGESTIVE HEART FAILURE (CHF), LIFE THREATENING BLEEDING, MYOCARDIAL INFARCTION (MI), STRUCTURAL VALVE-RELATED DYSFUNCTION REQUIRING REPEAT PROCEDURE, TACHYCARDIA RESULTING IN HEMODYNAMIC INSTABILITY, ENDOCARDITIS, LEFT BUNDLE BRANCH BLOCK (LBBB) REQUIRING PERMANENT PACEMAKER IMPLANT, MILD AORTIC TRANSVALVULAR REGURGITATION (AR), MODERATE PARAVALVULAR LEAK (PVL), AORTIC STENOSIS (AS), PATIENT-PROSTHESIS MISMATCH (PPM), AND HOSPITALIZATION FOR VALVE-RELATED SYMPTOMS. SPECIFIC TO THE ENVEO DELIVERY CATHETER SYSTEM (DCS) ADVERSE EVENTS INCLUDED: VALVE MALPOSITION DURING PLACEMENT AND ACCESS SITE COMPLICATIONS. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT WAS DIRECTLY ASSOCIATED WITH THE REFERENCED ADVERSE EVENT(S). NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    893957 MEDTRONIC TRANSCATHETER VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION MDT-TRANS VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death| H| L| R