BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC SURGICAL TISSUE VALVE

    MDR report key: 12550235 · Received September 29, 2021

    Report

    Report Number
    2025587-2021-02925
    Event Type
    Injury
    Date Received
    September 29, 2021
    Date of Event
    May 13, 2021
    Report Date
    September 29, 2021
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    DYE
    PMA / PMN Number
    P990064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: PAPARELLA D, ET AL. MINIMALLY INVASIVE AORTIC VALVE REPLACEMENT: SHORT-TERM EFFICACY OF SUTURELESS COMPARED WITH STENTED B IOPROSTHESES. INTERACT CARDIOVASC THORAC SURG. 2021 JUL 26;33(2):188-194. DOI: 10.1093/ICVTS/IVAB070. ADVANCE ACCESS PUBLICATION 13 MAY 2021. 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 SHORT-TERM OUTCOMES OF PATIENTS UNDERGOING MINIMALLY INVASIVE AORTIC VALVE REPLACEMENT USING SUTURELESS OR STANDARD BIOPROSTHESES. ALL DATA WAS PROSPECTIVELY COLLECTED AND RETROSPECTIVELY ANALYZED FROM ELEVEN CENTERS BETWEEN JANUARY 2011 AND DECEMBER 2019. OF THE 3,402 PATIENTS INCLUDED IN THE STUDY POPULATION, 2,927 (PREDOMINANTLY MALE, MEDIAN AGE 75 YEARS) WERE IMPLANTED WITH A STANDARD BIOPROSTHETIC AORTIC VALVE FROM ONE OF THE FOLLOWING MANUFACTURERS: MEDTRONIC (HANCOCK II AND MOSAIC), EDWARDS (CARPENTIER-EDWARDS), OR LIVANOVA/SORIN (MITROFLOW AND CROWN PRT). NO UNIQUE DEVICE IDENTIFIER NUMBERS WERE PROVIDED. IN THE STANDARD BIOPROSTHETIC AORTIC VALVE GROUP, 43 DEATHS OCCURRED. NO STATEMENT WAS MADE SUGGESTING A CAUSAL OR CONTRIBUTORY RELATIONSHIP BETWEEN MEDTRONIC PRODUCT AND THE DEATHS. IN THE STANDARD BIOPROSTHETIC AORTIC VALVE GROUP, POST-OPERATIVE ADVERSE EVENTS INCLUDED: BLOOD TRANSFUSION; NEW-ONSET ATRIAL FIBRILLATION; PERMANENT PACEMAKER IMPLANTATION; WOUND INFECTION; SEPSIS; RE-OPENING FOR BLEEDING/COMPLICATIONS; PULMONARY COMPLICATION/REINTUBATION; TRACHEOSTOMY; STROKE; LOW CARDIAC OUTPUT NECESSITATING INTRA-AORTIC BALLOON PUMP SUPPORT AND/OR INOTROPIC USE FOR MORE THAN 2 DAYS; AND CARDIAC ARREST. 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
    1445976 MEDTRONIC SURGICAL TISSUE VALVE REPLACEMENT HEART-VALVE DYE MEDTRONIC HEART VALVES DIVISION MDT-TISSUE VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Life Threatening| R