BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFILE 3D

    MDR report key: 12255362 · Received July 30, 2021

    Report

    Report Number
    2025587-2021-02423
    Event Type
    Injury
    Date Received
    July 30, 2021
    Date of Event
    May 21, 2020
    Report Date
    July 30, 2021
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    KRH
    PMA / PMN Number
    K073324
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: OTERO D., ET AL. TRANSCATHETER EDGE-TO-EDGE MITRAL VALVE REPAIR FOR ANNULOPLASTY RING DEHISCENCE: THE PERI-RING APPROACH. CASE REPORTS-CATHETER CARDIOVASC INTERV. 2021 APR 1;97(5):E727-E730. DOI: 10.1002/CCD.28952. PMID: 32438485. EPUB 2020 MAY 21. EARLIEST DATE OF PUBLISH USED FOR DATE OF EVENT. MEDTRONIC PRODUCTS REFERENCED: PROFILE 3D (PMA# K073324, 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 A (B)(6) YEAR-OLD MALE PATIENT WITH A HISTORY OF SEVERE MITRAL REGURGITATION, LEFT VENTRICULAR DYSFUNCTION, CORONARY ARTERY DISEASE STATUS-POST CORONARY BYPASS GRAFTING, PERIPHERAL VASCULAR DISEASE, DIABETES MELLITUS AND OBESITY. THE PATIENT WAS HOSPITALIZED WITH SEVERE HEART FAILURE (HF) SYMPTOMS APPROXIMATELY TWO YEARS AFTER HE UNDERWENT IMPLANT OF A 30-MM MEDTRONIC PROFILE 3D ANNULOPLASTY RING (UNIQUE DEVICE IDENTIFIER NUMBER NOT PROVIDED). IN THE YEAR PRIOR TO HOSPITALIZATION, FOLLOW-UP ECHOCARDIOGRAPHY REVEALED EVIDENCE OF PARTIAL ANNULOPLASTY RING DEHISCENCE AND MILD-MODERATE MITRAL REGURGITATION (MR). UPON HOSPITALIZATION, ECHOCARDIOGRAPHY NOTED SEVERE MR AND CENTRAL PARAVALVULAR LEAK (PVL) DUE TO MITRAL LEAFLET MAL-COAPTATION CAUSED BY THE DEHISCENCE. THE PATIENT WAS TREATED INITIALLY WITH INOTROPIC, VASODILATOR AND DIURETIC MEDICATIONS, HE LATER UNDERWENT TRANSCATHETER MITRAL VALVE REPAIR USING A NON-MEDTRONIC CLIP DEVICE. THE PATIENT¿S STATUS IMPROVED AND, UPON ONE-MONTH FOLLOW-UP AFTER HOSPITAL DISCHARGE, WAS STABLE WITH IMPROVED HF SYMPTOMS AND REDUCED MR. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1147984 PROFILE 3D RING, ANNULOPLASTY KRH MEDTRONIC HEART VALVES DIVISION 680R

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R