BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 10446516 · Received August 24, 2020

    Report

    Report Number
    2025587-2020-02666
    Event Type
    Injury
    Date Received
    August 24, 2020
    Date of Event
    August 3, 2020
    Report Date
    August 24, 2020
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: OKUNO T ET AL. IMPACT OF LEFT VENTRICULAR OUTFLOW TRACT CALCIFICATION ON PROCEDURAL OUTCOMES AFTER TRANSCATHETER AORTIC VALVE REPLACEMENT. JACC CARDIOVASC INTERV. 2020 AUG 10;13(15):1789-1799. DOI: 10.1016/J.JCIN.2020.04.015. AVAILABLE ONLINE 3 AUGUST 2020. SUPPLEMENTARY APPENDIX ATTACHED. EARLIEST DATE OF PUBLISH USED FOR DATE OF EVENT. MEDTRONIC PRODUCTS REFERENCED: COREVALVE (PMA# P130021, PRO CODE NPT), EVOLUT R (PMA# P130021, PRO CODE NPT), EVOLUT PRO (PMA# P130021, PRO CODE NPT). 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. (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION FROM A LITERATURE ARTICLE REGARDING AN ASSESSMENT OF LEFT VENTRICULAR OUTFLOW TRACT CALCIFICATION ON PROCEDURAL OUTCOMES AND DEVICE PERFORMANCES WITH CONTEMPORARY TRANSCATHETER HEART VALVE SYSTEMS. ALL DATA WERE RETROSPECTIVELY COLLECTED FROM A SINGLE CENTER REGISTRY BETWEEN AUGUST 2007 AND JUNE 2018. THE STUDY POPULATION INCLUDED 1,635 PATIENTS AND WAS PREDOMINANTLY FEMALE WITH A MEAN AGE OF 82 YEARS. OF THOSE, 771 WERE TREATED WITH SELF-EXPANDING TRANSCATHETER VALVES. IN THE SELF-EXPANDING VALVE SUBGROUP, AN UNSPECIFIED NUMBER OF PATIENTS WERE IMPLANTED WITH THE MEDTRONIC COREVALVE, EVOLUT R, AND EVOLUT PRO. NO SERIAL NUMBERS WERE PROVIDED. ONE PATIENT WAS IDENTIFIED AS AN (B)(6)-YEAR-OLD FEMALE WHO WAS IMPLANTED WITH A 31 MM COREVALVE AND DIED IN-HOSPITAL DUE TO ANNULAR RUPTURE (SUPPLEMENTAL TABLE 1; CASE 4). IT WAS REPORTED THAT THE ANNULAR RUPTURE WAS ATTRIBUTED TO A POST-IMPLANT BALLOON AORTIC VALVULOPLASTY THAT WAS PERFORMED TO MITIGATE RESIDUAL PARAVALVULAR LEAK. THE PATIENT RECEIVED CONSERVATIVE MANAGEMENT FOR THE RUPTURE, WHICH MAY HAVE INCLUDED: RESUSCITATION WITH OR WITHOUT MECHANICAL SUPPORT, OPTIMIZATION OF THE COAGULATION STATUS, OR PERICARDIAL DRAINAGE. IN ADDITION, IT WAS NOTED THE PATIENT HAD CALCIFICATION IN THE REGION OF THE FREE MYOCARDIAL WALL AND IN THE INTERVENTRICULAR SEPTUM. BASED ON THE AVAILABLE INFORMATION, MEDTRONIC PRODUCT WAS ASSOCIATED WITH THIS DEATH. AMONG ALL OTHER PATIENTS, THE 30-DAY ALL-CAUSE MORTALITY INCLUDED 48 PATIENTS. NO FURTHER DETAILS WERE PROVIDED. BASED ON THE AVAILABLE INFORMATION, MEDTRONIC PRODUCT WAS NOT DIRECTLY ASSOCIATED WITH THESE DEATHS. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: VALVE-IN-VALVE IMPLANTATION/NEED FOR SECOND VALVE IMPLANTATION DUE TO VALVE DISLOCATION /EMBOLIZATION OR RESIDUAL SIGNIFICANT AORTIC REGURGITATION; PERMANENT PACEMAKER IMPLANTATION; DISABLING STROKE; MYOCARDIAL INFARCTION; CARDIAC TAMPONADE; CORONARY ARTERY OCCLUSION; MILD TO SEVERE AORTIC REGURGITATION; MAJOR OR LIFE-THREATENING BLEEDING; AND MAJOR VASCULAR COMPLICATIONS. BASED ON THE AVAILABLE INFORMATION, MEDTRONIC PRODUCT MAY HAVE BEEN ASSOCIATED WITH THE ADVERSE EVENTS. AN ADDITIONAL 9 CASES OF ANNULAR RUPTURE OCCURRED IN PATIENTS WHO WERE IMPLANTED WITH NON-MEDTRONIC TRANSCATHETER VALVES. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    905435 MEDTRONIC TRANSCATHETER VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION MDT-TRANS VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Life Threatening| R| S