BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIMPLICI-T BAND

    MDR report key: 10041616 · Received May 10, 2020

    Report

    Report Number
    2025587-2020-01600
    Event Type
    Injury
    Date Received
    May 10, 2020
    Date of Event
    August 27, 2019
    Report Date
    May 10, 2020
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    KRH
    PMA / PMN Number
    K052970
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: DAVID TE ET AL. LONG-TERM RESULTS OF MITRAL VALVE REPAIR FOR REGURGITATION DUE TO LEAFLET PROLAPSE. JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY. 2019; 74(8):1044-1053. DOI: 10.1016/J.JACC.2019.06.052. EARLIEST DATE OF PUBLISH USED FOR EVENT 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. 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 THE LONG-TERM RESULTS OF MITRAL VALVE REPAIR FOR CORRECTING REGURGITATION FOLLOWING LEAFLET PROLAPSE. ALL DATA WERE COLLECTED FROM MULTIPLE CENTERS BETWEEN 1981 AND 2010. THE STUDY POPULATION INCLUDED 1234 PATIENTS (PREDOMINANTLY MALE, MEDIAN AGE 59 YEARS), 339 OF WHICH WERE IMPLANTED WITH MEDTRONIC SIMPLICI-T ANNULOPLASTY BANDS (NO SERIAL NUMBERS PROVIDED). AMONG ALL PATIENTS, 324 DEATHS OCCURRED THROUGHOUT THE FOLLOW-UP PERIOD. IT WAS REPORTED THAT 7 DEATHS OCCURRED WITHIN 90 DAYS OF IMPLANT, AND 317 DEATHS OCCURRED BEYOND 90 DAYS POST IMPLANT. OF THE LATE-STAGE DEATHS, 115 WERE CLASSIFIED AS CARDIAC, 193 NON-CARDIAC, AND 9 UNKNOWN CAUSE. FURTHERMORE, 2 DEATHS OCCURRED DURING REOPERATION, 2 DEATHS OCCURRED FROM ENDOCARDITIS, 14 DEATHS OCCURRED FOLLOWING A STROKE, 11 DEATHS OCCURRED FROM MAJOR BLEEDING, AND 1 DEATH OCCURRED FROM HEART FAILURE. MULTIPLE MANUFACTURERS WERE NOTED IN THE LITERATURE, AND THERE WAS NO ASSOCIATION BETWEEN MEDTRONIC PRODUCT AND ANY OF THE DEATHS. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT WAS NOT DIRECTLY ASSOCIATED WITH THE DEATHS. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: INFECTIVE ENDOCARDITIS, THROMBOEMBOLISM, STROKE, TRANSIENT ISCHEMIC ATTACK (TIA), MAJOR BLEEDING, HEMOLYSIS, SYSTOLIC ANTERIOR MOTION, STENOSIS, PANNUS FORMATION, HEART FAILURE, MODERATE-SEVERE MITRAL REGURGITATION, MOD ERATE-SEVERE TRICUSPID REGURGITATION, PACEMAKER IMPLANTATION, ATRIAL FIBRILLATION. A TOTAL OF 48 PATIENTS REQUIRED REOPERATION. BASED ON THE AVAILABLE INFORMATION 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
    505280 SIMPLICI-T BAND RING, ANNULOPLASTY KRH MEDTRONIC HEART VALVES DIVISION 670100

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention