BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE AORTIC ROOT BIOPROSTHESIS

    MDR report key: 5687652 · Received May 30, 2016

    Report

    Report Number
    2025587-2016-00792
    Event Type
    Injury
    Date Received
    May 30, 2016
    Date of Event
    April 1, 2016
    Report Date
    May 2, 2016
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: YONEZU, K. RUPTURED SAPHENOUS VEIN GRAFT PSEUDOANEURYSM SUCCESSFULLY TREATED WITH COVERED STENTS. CARDIOVASC INTERV AND THER (2016) 31:161¿163 DATE OF PUBLISH USED FOR EVENT DATE. NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION, IT COULD NOT BE DETERMINED WHETHER THIS EVENT HAS BEEN PREVIOUSLY REPORTED. (B)(4).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REVIEW OF A (B)(6) YEAR-OLD MALE PATIENT WITH A HISTORY OF AORTIC VALVE STREPTOCOCCAL INFECTIVE ENDOCARDITIS, ROOT ABSCESS AND SEVERE AORTIC REGURGITATION REQUIRING EMERGENT AORTIC ROOT REPLACEMENT WITH NON-MEDTRONIC DEVICE. TWENTY-TWO DAYS LATER, AN ECHOCARDIOGRAM REVEALED LEFT VENTRICULAR PSEUDOANEURYSM WITH SHUNT FLOW FROM THE LEFT VENTRICLE TO THE RIGHT ATRIUM. SUBSEQUENTLY, THE PATIENT UNDERWENT A SECOND AORTIC VALVE REPLACEMENT TO IMPLANT A MEDTRONIC FREESTYLE BIOPROSTHESIS(SERIAL NUMBER NOT PROVIDED) AND CORONARY ARTERY RECONSTRUCTION. EIGHTEEN DAYS LATER, THE PATIENT PRESENTED WITH SUDDEN ONSET CHEST PAIN. AN ECHOCARDIOGRAM REVEALED A HEMATOMA, PERICARDIAL EFFUSION, CARDIAC TAMPONADE AND RIGHT VENTRICLE COLLAPSE. A COMPUTED TOMOGRAPHY SHOWED EXTRAVASATION, HEMOPERICARDIUM, AND PSEUDOANEURYSM AT THE SAPHENOUS VEIN GRAFT (SVG) AND RIGHT CORONARY ARTERY (RCA) ANASTOMOTIC SITE. ANGIOGRAPHY WITH PERCUTANEOUS CORONARY INTERVENTION REVEALED A RUPTURED PSEUDOANEURYSM AT THE SVG-RCA SITE. GUIDEWIRES WERE USED TO SUCCESSFULLY DELIVER A COVERED STENT AND DRAINING OF THE PERICARDIAL DRAINAGE WAS PERFORMED. THE PATIENT RECOVERED WITH NO ADDITIONAL ADVERSE EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342237 FREESTYLE AORTIC ROOT BIOPROSTHESIS HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION 995

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Life Threatening| R