BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC SURGICAL TISSUE VALVE

    MDR report key: 12021961 · Received June 17, 2021

    Report

    Report Number
    2025587-2021-01936
    Event Type
    Injury
    Date Received
    June 17, 2021
    Date of Event
    October 24, 2020
    Report Date
    June 17, 2021
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    DYE
    PMA / PMN Number
    P990064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: HUSSO A, ET AL. TRANSCATHETER AND SURGICAL AORTIC VALVE REPLACEMENT IN PATIENTS WITH BICUSPID AORTIC VALVE. CLIN RES CARDIOL. 2021 MAR;110(3):429-439. DOI: 10.1007/S00392-020-01761-3. EPUB 2020 OCT 24. EARLIEST DATE OF PUBLISH USED FOR DATE OF EVENT. MEDTRONIC PRODUCTS REFERENCED: HANCOCK II (PMA# P980043, PRODUCT CODE DYE), MOSAIC (PMA# P990064, PRODUCT CODE DYE). 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 FROM A LITERATURE ARTICLE REGARDING THE OUTCOMES OF PATIENTS WITH NATIVE BICUSPID AORTIC VALVES WHO UNDERWENT TRANSCATHETER (TAVR) OR SURGICAL AORTIC VALVE REPLACEMENT (SAVR). ALL DATA WAS RETROSPECTIVELY COLLECTED FROM A FIVE-CENTER REGISTRY BETWEEN JANUARY 2008 AND NOVEMBER 2017. THE OVERALL STUDY POPULATION INCLUDED 1 ,023 PATIENTS (TAVR = 103, SAVR = 920). OF THE TAVR PATIENTS (PREDOMINANTLY FEMALE, MEAN AGE 77.1 YEARS), 10 PATIENTS WERE IMPLANTED WITH MEDTRONIC TRANSCATHETER VALVES: COREVALVE (2) OR EVOLUT (8). OF THE SAVR PATIENTS (PREDOMINANTLY FEMALE, MEAN AGE 70.9 YEARS), 74 PATIENTS WERE IMPLANTED WITH MEDTRONIC SURGICAL VALVES: HANCOCK II (54) OR MOSAIC (20). NO UNIQUE DEVICE IDENTIFIER NUMBERS WERE PROVIDED. THE TWO-YEAR MORTALITY RATES FOR THE TAVR AND SAVR COHORTS WERE 11.0% AND 6.5%, RESPECTIVELY. NON-MEDTRONIC TRANSCATHETER AND SURGICAL VALVES WERE ALSO USED IN THE STUDY. NONE OF THE DEATHS WERE DIRECTLY ATTRIBUTED TO MEDTRONIC PRODUCT. AMONG ALL TAVR PATIENTS, EARLY POST-OPERATIVE ADVERSE EVENTS INCLUDED: STROKE, VALVE MIGRATION, NEW PERMANENT PACEMAKER IMPLANTATION, CORONARY OSTIUM OCCLUSION, AORTIC DISSECTION/RUPTURE, MAJOR VASCULAR COMPLICATIONS, NEED FOR RED BLOOD CELL TRANSFUSION (MORE THAN 4 UNITS), REOPERATION FOR BLEEDING, CORONARY ARTERY BYPASS GRAFTING BLEEDING (EUROPEAN GRADES 2-3), AND NEW ATRIAL FIBRILLATION. MEDTRONIC PRODUCT MAY HAVE BEEN ASSOCIATED WITH THE ADVERSE EVENTS. MILD PARAVALVULAR REGURGITATION WAS OBSERVED IN ONE COREVALVE PATIENT AND TWO EVOLUT PATIENTS. AMONG ALL SAVR PATIENTS, EARLY POST-OPERATIVE ADVERSE EVENTS INCLUDED: STROKE, DEEP STERNAL WOUND INFECTION/MEDIASTINITIS, NEW PERMANENT PACEMAKER IMPLANTATION, CORONARY OSTIUM OCCLUSION, AORTIC DISSECTION/RUPTURE, MAJOR VASCULAR COMPLICATIONS, NEED FOR RED BLOOD CELL TRANSFUSION (MORE THAN 4 UNITS), REOPERATION FOR BLEEDING, CORONARY ARTERY BYPASS GRAFTING BLEEDING (EUROPEAN GRADES 2-3), AND NEW ATRIAL FIBRILLATION. AFTER SAVR, THE TWO-YEAR RATE OF REPEAT OPERATION FOR UNSPECIFIED VALVE-RELATED COMPLICATION WAS 1.3%. MEDTRONIC PRODUCT MAY HAVE BEEN ASSOCIATED WITH THE ADVERSE EVENTS. MILD PARAVALVULAR REGURGITATION WAS OBSERVED IN TWO HANCOCK II PATIENTS AND ONE MOSAIC PATIENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    911411 MEDTRONIC SURGICAL TISSUE VALVE REPLACEMENT HEART-VALVE DYE MEDTRONIC HEART VALVES DIVISION MDT-TISSUE VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Life Threatening| R