BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC SURGICAL ANNULOPLASTY PRODUCTS

    MDR report key: 12701348 · Received October 26, 2021

    Report

    Report Number
    2025587-2021-03162
    Event Type
    Injury
    Date Received
    October 26, 2021
    Date of Event
    November 6, 2020
    Report Date
    October 26, 2021
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    KRH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: ALGARNI KD, ET AL. DEGREE OF RIGHT VENTRICULAR DYSFUNCTION DICTATES OUTCOMES AFTER TRICUSPID VALVE REPAIR CONCOMITANT WITH LEFT SIDE VALVE SURGERY. GEN THORAC CARDIOVASC SURG. 2021 JUN;69(6):911-918. DOI: 10.1007/S11748-020-01536-7. EPUB 2020 NOV 6. EARLIEST DATE OF PUBLISH USED FOR DATE OF EVENT. MEDTRONIC PRODUCTS REFERENCED: CONTOUR 3D (PMA# K101212, PRODUCT CODE KRH), TRI-AD (PMA# K093903, PRODUCT CODE KRH), DURAN (PMA# K960356, PRODUCT CODE KRH), SIMPLICI-T (PMA# K052970, 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 · 0

    MEDTRONIC RECEIVED INFORMATION FROM A LITERATURE ARTICLE REGARDING THE EFFECT OF PRE-OPERATIVE RIGHT VENTRICULAR DYSFUNCTION ON MORTALITY AND RECURRENCE OF TRICUSPID REGURGITATION AFTER TRICUSPID VALVE REPAIR FOR SECONDARY TRICUSPID REGURGITATION CONCOMITANT WITH LEFT-SIDE VALVE SURGERY. ALL DATA WAS RETROSPECTIVELY COLLECTED FROM A SINGLE CENTER BETWEEN JANUARY 2009 AND DECEMBER 2017. OF THE 548 PATIENTS INCLUDED IN THE STUDY POPULATION (PREDOMINANTLY FEMALE, MEDIAN AGE 46 YEARS), 122 UNDERWENT TRICUSPID VALVE REPAIR WITH A MEDTRONIC ANNULOPLASTY DEVICE: CONTOUR 3D RING (1), TRI-AD RING (1), DURAN BAND (119), OR SIMPLICI-T BAND (1). NO UNIQUE DEVICE IDENTIFIER NUMBERS WERE PROVIDED. AMONG ALL PATIENTS, THE HOSPITAL MORTALITY (WHICH WAS DEFINED AS ANY DEATH WITHIN 30 DAYS OF THE PROCEDURE OR ANY DEATH IN HOSPITAL) INCLUDED 22 PATIENTS. NO STATEMENT WAS MADE SUGGESTING A CAUSAL OR CONTRIBUTORY RELATIONSHIP BETWEEN MEDTRONIC PRODUCT AND THE DEATHS. AMONG ALL PATIENTS, POST-OPERATIVE ADVERSE EVENTS INCLUDED: INTRA-AORTIC BALLOON PUMP SUPPORT, EXTRACORPOREAL MEMBRANE OXYGENATION SUPPORT, PROLONGED VENTILATION, ATRIAL FIBRILLATION (NEW ONSET OR PRESENT AT HOSPITAL DISCHARGE), AND MODERATE TO SEVERE RECURRENT TRICUSPID REGURGITATION (MEAN TIME TO RECURRENCE OF TRICUSPID REGURGITATION WAS 19.5 MONTHS AFTER SURGERY). 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
    1598537 MEDTRONIC SURGICAL ANNULOPLASTY PRODUCTS RING, ANNULOPLASTY KRH MEDTRONIC HEART VALVES DIVISION MDT-ANNULOPLASTY

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention