BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE AORTIC ROOT BIOPROSTHESIS

    MDR report key: 11968115 · Received June 9, 2021

    Report

    Report Number
    2025587-2021-01831
    Event Type
    Injury
    Date Received
    June 9, 2021
    Date of Event
    January 25, 2020
    Report Date
    June 9, 2021
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P970031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: KEELING W., ET AL. BENCHMARKING OUTCOMES: REOPERATION FOR AORTIC VALVE PATIENT-PROSTHESIS MISMATCH. ANN THORAC SURG. 2021 MAY;111(5):1472-1477. PMID: 32980325. DOI: 10.1016/J.ATHORACSUR.2020.07.032. EPUB 2020 SEP 24. PRESENTED AT THE FIFTY-SIXTH ANNUAL MEETING OF THE SOCIETY OF THORACIC SURGEONS, NEW ORLEANS, LA, JAN 25-28, 2020. EARLIEST DATE OF PUBLISH USED FOR DATE OF EVENT AND DATE OF DEATH. MEDTRONIC PRODUCTS REFERENCED: FREESTYLE (PMA# P970031, PRODUCT CODE: LWR); ATS OPEN PIVOT (PMA# P990046, PRODUCT CODE: LWQ); HANCOCK (PMA# P790007, PRODUCT CODE: LWR); 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 VIA LITERATURE REGARDING OUTCOMES AFTER RE-OPERATION TO REPLACE AORTIC VALVES DUE TO PATIENT-PROSTHESIS MISMATCH (PPM). ALL DATA WERE RETROSPECTIVELY COLLECTED FROM A SINGLE CENTER BETWEEN JANUARY 2004 AND JANUARY 2018. THE STUDY POPULATION INCLUDED 60 PATIENTS (PREDOMINANTLY FEMALE, MEAN AGE 63 YEARS). ONE PATIENT WAS PREVIOUSLY IMPLANTED WITH AN 18-MM MEDTRONIC ATS MECHANICAL SURGICAL AORTIC VALVE, TWO PATIENTS WERE PREVIOUSLY IMPLANTED WITH 19-MM MEDTRONIC HANCOCK BIOPROSTHETIC AORTIC VALVED CONDUITS AND NINE PATIENTS WERE PREVIOUSLY IMPLANTED WITH MEDTRONIC MOSAIC BIOPROSTHETIC AORTIC VALVES (UNIQUE DEVICE IDENTIFIER NUMBERS NOT PROVIDED). OF THE STUDY POPULATION, 47 PATIENTS WHO UNDERWENT RE-DO AORTIC VALVE REPLACEMENT WERE SURGICALLY IMPLANTED WITH MEDTRONIC FREESTYLE BIOPROSTHETIC VALVES (UNIQUE DEVICE IDENTIFIER NUMBERS NOT PROVIDED). AMONG ALL PATIENTS, THREE IN-HOSPITAL DEATHS OCCURRED, DUE TO POST-OPERATIVE SEPSIS IN TWO PATIENTS AND POST-OPERATIVE BIVENTRICULAR FAILURE IN THE THIRD PATIENT. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT MAY HAVE BEEN ASSOCIATED WITH THE DEATHS. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: PERMANENT STROKE AND HEMORRHAGE REQUIRING SURGICAL RE-EXPLORATION. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT MAY HAVE BEEN ASSOCIATED WITH THE ADVERSE EVENTS. AMONG ALL MEDTRONIC ATS MECHANICAL, HANCOCK AND MOSAIC PATIENTS, ADVERSE EVENTS INCLUDED: PATIENT-PROSTHESIS MISMATCH REQUIRING RE-DO AORTIC VALVE REPLACEMENT SURGERY. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT WAS DIRECTLY 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
    867031 FREESTYLE AORTIC ROOT BIOPROSTHESIS HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION 995

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| L| R