BEUDAMED
    FDA Adverse Event Injury Summary report: N

    27MM MOSAIC AORTIC VALVE

    MDR report key: 5286395 · Received December 10, 2015

    Report

    Report Number
    2025587-2015-01309
    Event Type
    Injury
    Date Received
    December 10, 2015
    Date of Event
    May 1, 2015
    Report Date
    November 11, 2015
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P990064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TITLE: MULTIMODALITY IMAGE GUIDANCE WITH DYNA-CT FOR TRANSCATHETER TREATMENT OF PARAVALVULAR LEAK OF A STENTLESS VALVE CITATION: CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS 85:1088¿1091 (2015) AUTHORS: BRETT VAN LEER-GREENBERG MD, CLAUDIA A. MARTINEZ MD, FSCAI, AND ALAN W. HELDMAN MD. NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT CANNOT BE DETERMINED WHETHER THIS EVENT HAS BEEN PREVIOUSLY REPORTED.

    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 VIA LITERATURE REVIEW THAT AN (B)(6) MALE PATIENT WHO HAD UNDERGONE IMPLANT OF A MEDTRONIC 27-MM AORTIC BIOPROSTHETIC VALVE (SERIAL NUMBER NOT PROVIDED) FIVE YEARS PRIOR PRESENTED WITH HEART FAILURE SYMPTOMS AND DECREASED LEFT VENTRICULAR SYSTOLIC FUNCTION. TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) IDENTIFIED AN AORTIC PARAVALVULAR LEAK (PVL), AND DOPPLER DEMONSTRATED SEVERE ANTERIOR PARAVALVULAR REGURGITATION. DUE TO THE PATIENT'S WORSENING SYMPTOMS, LOW EJECTION FRACTION, AND OVERALL FRAILTY A PERCUTANEOUS CLOSURE OF THE PVL WAS OPTED FOR. IN THE REVISION PROCEDURE A NON-MEDTRONIC CATHETER-BASED OCCLUDING DEVICE WAS IMPLANTED WHICH SUCCESSFULLY REDUCED THE PVL FROM SEVERE TO MILD. THE PATIENT TOLERATED THE PROCEDURE WELL WITHOUT INCIDENT AND WAS SUBSEQUENTLY DISCHARGED FOR FOLLOW-UP WITH HIS PRIVATE CARDIOLOGIST. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    814345 27MM MOSAIC AORTIC VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION 042364027

    Patients

    Seq Age Sex Outcome Treatment
    1 00082 YR Required Intervention