BEUDAMED
    FDA Adverse Event Death Summary report: N

    FREESTYLE AORTIC ROOT BIOPROSTHESIS

    MDR report key: 11127406 · Received January 6, 2021

    Report

    Report Number
    2025587-2021-00044
    Event Type
    Death
    Date Received
    January 6, 2021
    Date of Event
    March 24, 2011
    Report Date
    January 6, 2021
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P970031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: O¿KEEFE K., ET AL. EARLY CATASTROPHIC STENTLESS VALVE FAILURE SECONDARY TO POSSIBLE IMMUNE REACTION. ANNALS OF THORACIC SURGERY, APRIL 2011; 91(4):1269-1272. DOI: 10.1016/J.ATHORACSUR.2010.09.042. AVAILABLE ONLINE 24 MARCH 2011. EARLIEST DATE OF PUBLISH USED FOR EVENT DATE AND DEATH DATE. MEDTRONIC PRODUCTS REFERENCED: FREESTYLE (PMA# P970031, PRODUCT CODE: LWR). 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 OF A CASE REPORT INVOLVING TWO PATIENTS WITH IMMUNOLOGIC REACTIONS TO BIOPROSTHETIC AORTIC ROOT IMPLANTS. THE FIRST PATIENT WAS AN (B)(6)-YEAR-OLD WOMAN WITH CORONARY ARTERY DISEASE STATUS-POST REVASCULARIZATION, HYPERLIPIDEMIA AND ATRIOVENTRICULAR BLOCK REQUIRING A PACEMAKER, SEVERE AORTIC STENOSIS AND MODERATE AORTIC INSUFFICIENCY. THE PATIENT WAS IMPLANTED WITH A 23-MM MEDTRONIC FREESTYLE BIOPROSTHETIC AORTIC ROOT (NO SERIAL NUMBERS PROVIDED). APPROXIMATELY 3.5 MONTHS POST-IMPLANT, THE PATIENT WAS RE-HOSPITALIZED WITH ANGINA AND TACHYARRHYTHMIAS. URGENT CARDIAC CATHETERIZATION REVEALED CORONARY VEIN GRAFT OCCLUSIONS AND DURING EMERGENCY SURGERY, DENSE SCARRING WAS NOTED AROUND THE FREESTYLE AORTIC ROOT. THE PATIENT LATER EXPIRED IN THE INTENSIVE CARE UNIT (ICU) AND AN AUTOPSY REVEALED INTENSE FIBROSIS AND INFLAMMATION DUE TO A FOREIGN BODY REACTION AROUND THE XENOGRAFT. THE SECOND PATIENT WAS A (B)(6)-YEAR-OLD OBESE WOMAN WITH HYPERTENSION, HYPERLIPIDEMIA, REFLUX DISEASE, SLEEP APNEA AND SEVERE AORTIC STENOSIS. THE PATIENT WAS IMPLANTED WITH A 25-MM MEDTRONIC FREESTYLE BIOPROSTHETIC AORTIC ROOT (NO SERIAL NUMBER PROVIDED). SIX MONTHS POST-IMPLANT, THE PATIENT DEVELOPED ANGINAL SYMPTOMS WITH CRUSHING CHEST PAIN. THE PATIENT WAS HOSPITALIZED AND URGENT CARDIAC CATHETERIZATION REVEALED LEFT MAIN CORONARY ARTERY OCCLUSION. DURING THAT PROCEDURE, THE PATIENT WENT INTO CARDIAC ARREST AND EXPIRED. AN AUTOPSY REVEALED SIGNIFICANT SCAR TISSUE FILLING THE RIGHT/LEFT OSTIA AND ALONG THE SURFACE OF THE BIOPROSTHETIC ROOT WITH INFLAMMATION DUE TO A FOREIGN BODY REACTION. BASED UPON THE AVAILABLE INFORMATION, MEDTRONIC PRODUCT MAY HAVE BEEN ASSOCIATED WITH THE ADVERSE EVENTS AND DEATHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22810 FREESTYLE AORTIC ROOT BIOPROSTHESIS HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION 995CS23

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death| H| L| R