BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT PRO TRANSCATHETER AORTIC VALVE

    MDR report key: 9129937 · Received September 27, 2019

    Report

    Report Number
    2025587-2019-02942
    Event Type
    Injury
    Date Received
    September 27, 2019
    Date of Event
    August 28, 2019
    Report Date
    January 30, 2020
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED VIA A LITERATURE EDITORIAL REPLY THAT ADDRESSED QUESTIONS PERTAINING TO THE DATA REPORTED IN THIS STUDY. IN THE REPLY, THE PHYSICIAN/AUTHOR NOTED THAT MORE THAN 3 VALVE RECAPTURES WERE PERFORMED IN AN UNSPECIFIED NUMBER OF CASES. CITATION: JILAIHAWI H ET AL. REPLY: DOES VALVE IMPLANTATION DEPTH DEFINED BY PRE-RELEASE ANGIOGRAM REFLECT THE FINAL DEPTH IN TAVR? JACC CARDIOVASC INTERV. 2019 DEC 9;12(23):2436-2437. DOI: 10.1016/J.JCIN.2019.10.046. 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 · 1

    CITATION: JILAIHAWI H ET AL. MINIMIZING PERMANENT PACEMAKER FOLLOWING REPOSITIONABLE SELF-EXPANDING TRANSCATHETER AORTIC VALVE REPLACEMENT. JACC CARDIOVASC INTERV. 2019 SEP 23;12(18):1796-1807. DOI: 10.1016/J.JCIN.2019.05.056. EPUB 2019 AUG 28. EARLIEST DATE OF PUBLISH USED FOR EVENT DATE. 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 THE 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 AN ANALYSIS OF THE FACTORS THAT CONTRIBUTE TO PERMANENT PACEMAKER IMPLANTATION WITH CONTEMPORARY REPOSITIONABLE SELF-EXPANDING DEVICES FOLLOWING TRANSCATHETER AORTIC VALVE REPLACEMENT AND AN ASSESSMENT OF THE ANATOMICALLY GUIDED MINIMIZING DEPTH ACCORDING TO THE MEMBRANOUS SEPTUM (MIDAS) APPROACH TO DEVICE IMPLANTATION. THE STUDY POPULATION ENCOMPASSED 2 COHORTS: 248 PATIENTS FROM A RETROSPECTIVE COHORT AND 100 PATIENTS FROM A PROSPECTIVE MIDAS COHORT (DEMOGRAPHICS WERE NOT PROVIDED FOR THE ENTIRE PATIENT POPULATION). ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN NOVEMBER 2016 AND MARCH 2018 FOR THE RETROSPECTIVE COHORT AND FROM THE SAME SINGLE CENTER BETWEEN JULY 2018 AND NOVEMBER 2018 FOR THE PROSPECTIVE MIDAS COHORT. ALL PATIENTS WERE IMPLANTED WITH MEDTRONIC EVOLUT R/XL OR EVOLUT PRO BIOPROSTHETIC VALVES. VALVE SIZES USED: 23, 26, 29, AND 34 MM (EVOLUT XL). NO SERIAL NUMBERS WERE PROVIDED. AMONG ALL PATIENTS, THE IN-HOSPITAL AND 30-DAY MORTALITY RATES WERE 0.4% AND 1.2%, RESPECTIVELY. NO OTHER DETAILS WERE REPORTED. BASED ON THE AVAILABLE INFORMATION, MEDTRONIC PRODUCT WAS NOT DIRECTLY ASSOCIATED WITH THE DEATHS. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: NEW PERMANENT PACEMAKER IMPLANTATION DUE TO COMPLETE HEART BLOCK OR HIGH-GRADE SECOND-DEGREE HEART BLOCK. IN ONE ADDITIONAL CASE, IT WAS NOTED THAT THE PATIENT DEVELOPED MOBITZ TYPE 1 HEART BLOCK, LEFT BUNDLE BRANCH BLOCK, OCCASIONAL DIZZY SPELLS, AND HEART RATE OF 50 BEATS/MIN WITH A REDUCED EJECTION FRACTION OF 25% REQUIRING IMPLANTATION OF A CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR. IT WAS STATED THAT THE MAJORITY OF PACEMAKERS WERE IMPLANTED WITHIN 72 HOURS POST IMPLANT, WITH ONLY 3 PATIENTS RECEIVING A PACEMAKER OUTSIDE THAT PERIOD (AT DAY 6, 11, AND 73 POST IMPLANT, RESPECTIVELY). OTHER ADVERSE EVENTS INCLUDED: IN-HOSPITAL STROKE, VALVE EMBOLIZATION (¿POP-OUT¿), NEW LEFT BUNDLE BRANCH BLOCK, PARAVALVULAR LEAK GREATER THAN OR EQUAL TO MODERATE, AND HIGH OR LOW (¿DEEP¿) IMPLANT DEPTH. THE REPORTED MEAN IMPLANT DEPTH FOR BOTH COHORTS WAS 3.3 ± 1.8 MM (RETROSPECTIVE COHORT) AND 2.3 ± 1.3 MM (PROSPECTIVE MIDAS COHORT), RESPECTIVELY. BASED ON THE AVAILABLE INFORMATION, MEDTRONIC PRODUCT MAY HAVE BEEN ASSOCIATED WITH THE ADVERSE EVENTS. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    923997 EVOLUT PRO TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION EVOLUTPRO-23

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention