BEUDAMED
    FDA Adverse Event Death Summary report: N

    COREVALVE REVALVING SYSTEM

    MDR report key: 6001674 · Received October 5, 2016

    Report

    Report Number
    2025587-2016-01576
    Event Type
    Death
    Date Received
    October 5, 2016
    Date of Event
    January 27, 2016
    Report Date
    October 5, 2016
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: IMPLANTATION DEPTH MEASURED BY 64-SLICE COMPUTED TOMOGRAPHY IS ASSOCIATED WITH PERMANENT PACEMAKER REQUIREMENT FOLLOWING TRANSCATHETER AORTIC VALVE IMPLANTATION WITH THE CORE VALVE SYSTEM CITATION: KAMMLER, J. IMPLANTATION DEPTH MEASURED BY 64-SLICE COMPUTED TOMOGRAPHY IS ASSOCIATED WITH PERMANENT PACEMAKER REQUIREMENT FOLLOWING TRANSCATHETER AORTIC VALVE IMPLANTATION WITH THE CORE VALVE SYSTEM. JOURNAL OF CARDIOLOGY; JUNE 2016; 67 (6):513¿518 (DO I.ORG/10.1016/J.JJCC.2015.12.008) AUTHORS: JURGEN KAMMLER (MD), HERMANN BLESSBERGER (MD), FRANZ FELLNER (MD), ALEXANDER KYPTA (MD), THOMAS LAMBERT (MD), MAGDALENA ENGL (MD), SIMON HONIG (MD), MICHAEL LICHTENAUER (MD), MICHAEL GRUND (MD), KLAUS KERSCHNER (MD), KARIM SALEH (MD), CLEMENS STEINWENDER (MD) EARLIEST DATE OF PUBLISH USED FOR EVENT DATE AND DEATH 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. 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

    REVIEW OF OUR COMPLAINT DATABASE FOUND THAT THIS EVENT WAS PREVIOUSLY REPORTED VIA MDR 2025587-2016-01022.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REVIEW THAT A STUDY WAS PERFORMED TO EVALUATE IMPLANTATION DEPTH OF THE PROSTHESIS AS A RISK FACTOR FOR CONDUCTION DISTURBANCES. THE STUDY POPULATION INCLUDED 89 PATIENTS, AMONG ALL PATIENTS, 2 DEATHS OCCURRED, WHICH INCLUDED: PERIPROCEDURAL ANNULAR RUPTURE, PERICARDIAL HEMORRHAGE AND TAMPONADE. OF THESE DEATHS, BOTH WERE ASSOCIATED WITH MEDTRONIC PRODUCTS. THE COHORT STUDY POPULATION INCLUDED 53 PATIENTS (PREDOMINANTLY FEMALE WITH A MEAN AGE OF 82 YEARS), ALL OF WHICH WERE IMPLANTED WITH MEDTRONIC COREVALVE (SERIAL NUMBERS NOT PROVIDED). AMONG THE 53 COHORT PATIENTS, 28 PATIENTS REQUIRED A PERMANENT PACEMAKER, WHICH INCLUDED: 20 PATIENTS DEVELOPED INTERMITTENT OR COMP LETE HEART BLOCK (CHB), 8 HAD NEW ONSET OF LEFT BUNDLE BRANCH BLOCK (LBBB), RIGHT BUNDLE BRANCH BLOCK (RBBB) WITH FIRST DEGREE ATRIO-VENTRICULAR (AV) BLOCK. OF THESE ADVERSE EVENTS, ALL WERE ASSOCIATED WITH MEDTRONIC PRODUCTS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652721 COREVALVE REVALVING SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION CRS-P3-943

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death| R