BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURAN ANCORE RING

    MDR report key: 12314477 · Received August 12, 2021

    Report

    Report Number
    2025587-2021-02538
    Event Type
    Injury
    Date Received
    August 12, 2021
    Date of Event
    August 6, 2020
    Report Date
    August 12, 2021
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    KRH
    PMA / PMN Number
    K032810
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: MOAZ-METZL D., ET AL. TRANSCATHETER TRICUSPID VALVE REPLACEMENT IN DEHISCED FLEXIBLE RING. CATHETER CARDIOVASC INTERV. 2021 APR 1; 97(5):E739-E742. DOI: 10.1002/CCD.29162. PMID: 32761862. EPUB 2020 AUG 6. EARLIEST DATE OF PUBLISH USED FOR DATE OF EVENT. MEDTRONIC PRODUCTS REFERENCED: DURAN ANCORE RING (PMA# K960356, 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.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REGARDING A (B)(6) YEAR-OLD FEMALE PATIENT WITH MORBID OBESITY, CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) AND CHILD-PUGH CLASS B CIRRHOSIS WHO HAD PREVIOUSLY UNDERGONE SURGICAL MITRAL VALVE REPAIR USING A 25-MM MEDTRONIC DURAN ANCORE ANNULOPLASTY RING AND SURGICAL TRICUSPID VALVE REPAIR USING A 27-MM MEDTRONIC DURAN ANCORE ANNULOPLASTY RING 13 YEARS PRIOR (UNIQUE DEVICE IDENTIFIER NUMBERS NOT PROVIDED). THE PATIENT WAS HOSPITALIZED WITH WORSENING HEART FAILURE WHERE AN ECHOCARDIOGRAM REVEALED SEVERE TRICUSPID MIXED STENOSIS/REGURGITATION WITH ELEVATED TRANSVALVULAR PRESSURE GRADIENTS, SEVERE RIGHT VENTRICULAR DILATATION WITH SEVERE HYPOKINESIS AND SEVERE PULMONARY HYPERTENSION. HEART CATHETERIZATION DEMONSTRATED ELEVATED PULMONARY VASCULAR PRESSURE AND ELEVATED LEFT ATRIAL PRESSURE. A CHEST COMPUTERIZED TOMOGRAPHY (CT) DEMONSTRATED SEPTAL DEHISCENCE OF THE DURAN RING. THE PATIENT UNDERWENT TRANSCATHETER TRICUSPID IN-VALVE REPLACEMENT WITH A 29-MM NON-MEDTRONIC VALVE. A THREE-MONTH FOLLOW-UP DEMONSTRATED SIGNIFICANT IMPROVEMENT IN SYMPTOMS AND TRICUSPID VALVE FUNCTION BY ECHOCARDIOGRAPHY. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1211688 DURAN ANCORE RING RING, ANNULOPLASTY KRH MEDTRONIC HEART VALVES DIVISION 620R

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| L| R DURAN MITRAL ANNULOPLASTY RING