BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC SURGICAL ANNULOPLASTY PRODUCTS

    MDR report key: 11973851 · Received June 10, 2021

    Report

    Report Number
    2025587-2021-01838
    Event Type
    Injury
    Date Received
    June 10, 2021
    Date of Event
    April 1, 2021
    Report Date
    June 10, 2021
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    KRH
    PMA / PMN Number
    K073324
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: KADAN M, ET AL. EARLY- AND MID-TERM RESULTS OF CRYOABLATION OF ATRIAL FIBRILLATION CONCOMITANT WITH ROBOTIC MITRAL VALVE SURGERY. ANATOL J CARDIOL. 2021 APR;25(4):266-272. DOI: 10.14744/ANATOLJCARDIOL.2020.81669. EARLIEST DATE OF PUBLISH USED FOR DATE OF EVENT. MEDTRONIC PRODUCTS REFERENCED: PROFILE 3D ANNULOPLASTY RING (PMA# K073324, PRODUCT CODE KRH) AND CONTOUR 3D ANNULOPLASTY RING (PMA# K101212, PRODUCT CODE KRH). 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 EARLY AND MID-TERM RESULTS OF CRYOABLATION FOR ATRIAL FIBRILLATION (AFIB) CONCOMITANT WITH ROBOTIC MITRAL VALVE SURGERY. ALL DATA WERE RETROSPECTIVELY COLLECTED FROM A SINGLE CENTER BETWEEN 2014 AND 2020. THE STUDY POPULATION INCLUDED 34 PATIENTS (PREDOMINANTLY FEMALE, MEAN AGE 58 YEARS), ALL OF WHOM WERE IMPLANTED WITH EITHER A MEDTRONIC OPEN PIVOT MECHANICAL HEART VALVE, HANCOCK BIOPROSTHETIC VALVE, PROFILE 3D OR CONTOUR 3D ANNULOPLASTY RING. SERIAL NUMBERS WERE NOT PROVIDED. AMONG ALL PATIENTS, TWO DEATHS OCCURRED DUE TO LOW CARDIAC OUTPUT SYNDROME AND HEPATORENAL SYNDROME AND WERE NOT ATTRIBUTED TO A MEDTRONIC DEVICE AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: FIRST DEGREE HEART BLOCK, NEW ONSET ATRIAL FIBRILLATION (AFIB) AND COMPLETE HEART BLOCK (CHB) TREATED WITH PERMANENT PACEMAKER, LEFT VENTRICLE BLEEDING TREATED WITH A STERNOTOMY AND MYOCARDIAL ISCHEMIA TREATED WITH THE IMPLANT OF A STENT. BASED ON THE AVAILABLE INFORMATION, A 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
    869682 MEDTRONIC SURGICAL ANNULOPLASTY PRODUCTS RING, ANNULOPLASTY KRH MEDTRONIC HEART VALVES DIVISION MDT-ANNULOPLASTY

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention