BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE AORTIC ROOT BIOPROSTHESIS

    MDR report key: 4172987 · Received October 15, 2014

    Report

    Report Number
    2025587-2014-00764
    Event Type
    Injury
    Date Received
    October 15, 2014
    Date of Event
    November 4, 1999
    Report Date
    October 28, 2014
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P970031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ARTICLE¿S CORRESPONDING AUTHOR WAS CONTACTED FOR ADDITIONAL DETAILS REGARDING THE DEVICE AND PATIENT; NO ADDITIONAL INFORMATION HAS BEEN RECEIVED TO DATE. WITHOUT IDENTIFYING INFORMATION FOR THE DEVICE, MEDTRONIC¿S COMPLAINT DATABASE COULD NOT BE SEARCHED TO DETERMINE IF THIS HAD PREVIOUSLY BEEN REPORTED. THE AVAILABLE INFORMATION INDICATES THAT THE DEVICE HAS NOT BEEN EXPLANTED. THE EVENT DATE ON THIS REPORT IS BASED ON THE PRESENTATION OF THE ARTICLE'S FINDINGS AT A PROFESSIONAL CONFERENCE. A SUPPLEMENTAL REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETED. (B)(4). STENTLESS AORTIC VALVE REPLACEMENT WITH FREESTYLE OR TORONTO SPV: AN EARLY COMPARISON AUTHORS: ROBERT D. RILEY, MD; JOHN W. HAMMON, JR., MD; SANDY M. ADAIR, RN; A. ROBERT CORDELL, MD; AND NEAL D. KON, MD ANNALS OF THORACIC SURGERY ANN THORAC SURG 2000;70:48¿52 DOI: 10.1016/S0003-4975(00)01559-9 PRESENTED AT THE FORTY-SIXTH ANNUAL MEETING OF THE SOUTHERN THORACIC SURGICAL ASSOCIATION, SAN JUAN, PUERTO RICO, NOV 4¿6, 1999. PUBLISHED ONLINE JULY 17, 2000.

    Additional Manufacturer Narrative · 1

    TO DATE, NO ADDITIONAL INFORMATION HAS BEEN RECEIVED FROM THE ARTICLE'S AUTHOR CONTACT. BASED ON THE CONTENT OF THE ARTICLE, THERE WAS NO INFORMATION AS TO WHICH DEVICES WERE ASSOCIATED WITH THE ADVERSE EVENTS. A DEVICE HISTORY RECORDS REVIEW COULD NOT BE PERFORMED, AS THE DEVICE SERIAL NUMBERS WERE NOT PROVIDED. BASED ON THE LIMITED INFORMATION RECEIVED, A ROOT CAUSE CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION FROM A JOURNAL ARTICLE THAT A PATIENT WITH AN IMPLANTED MODEL OF THIS AORTIC ROOT BIOPROSTHESIS EXPERIENCED A POST-OPERATIVE THROMBOEMBOLIC COMPLICATION THAT MANIFESTED AS EITHER A TRANSIENT ISCHEMIC ATTACK/CEREBROVASCULAR ACCIDENT. NO SUBSEQUENT ADVERSE PATIENT EFFECTS WERE REPORTED. THE ARTICLE NOTED THAT THERE WERE NO PERIOPERATIVE DEATHS RELATED TO THIS DEVICE FAMILY AND PATIENT POPULATION. NO VALVES IN EITHER MANUFACTURER¿S DEVICE POPULATION REQUIRED REOPERATION FOR ANY STRUCTURAL OR NONSTRUCTURAL DEGENERATION DURING THE STUDY PERIOD. THE ARTICLE REVIEWED OUTCOMES WITH THIS MODEL AORTIC ROOT BIOPROSTHESIS AND ANOTHER MANUFACTURER¿S DEVICE FROM A TWO-YEAR PERIOD OF IMPLANTS FROM A SINGLE MEDICAL FACILITY. THE ARTICLE¿S FINDINGS INCLUDED REVIEWS OF THE PATIENTS FOLLOWING IMPLANT AND SIX-MONTH FOLLOW-UPS. THE STUDY POPULATION INCLUDED 44 PATIENTS WHO WERE IMPLANTED WITH A MODEL OF THIS BIOPROSTHESIS. THE AVERAGE PATIENT AGE WAS 72; 52% WERE FEMALE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654709 FREESTYLE AORTIC ROOT BIOPROSTHESIS HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION 995

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Required Intervention