BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE

    MDR report key: 4803489 · Received May 28, 2015

    Report

    Report Number
    2025587-2015-00607
    Event Type
    Injury
    Date Received
    May 28, 2015
    Date of Event
    March 3, 2012
    Report Date
    April 30, 2015
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TITLE: AORTIC VALVE CUSP SHEARING AND MIGRATION INTO THE LEFT MAIN CORONARY ARTERY DURING TRANSCATHETER AORTIC VALVE IMPLANTATION AUTHORS: HADI DAOOD TOEG, MS, MD, MARINO LABINAZ, MD, CHRIS HUDSON, MD, AND MARC RUEL, MD, MPH CITATION: CANADIAN JOURNAL OF CARDIOLOGY 28 (2012) 611.E1¿ 611.E3 (HTTP://DX.DOI.ORG/10.1016/J.CJCA.2012.03.006) THE DATE OF PUBLISH WAS USED FOR THE EVENT DATE.

    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 THAT (B)(6) MALE PATIENT WITH A HISTORY OF SEVERE AORTIC STENOSIS UNDERWENT A PROCEDURE TO IMPLANT A 29 MM TRANSCATHETER BIOPROSTHETIC VALVE (SERIAL NOT REPORTED). DURING THE PROCEDURE THE PATIENT BECAME HYPOTENSIVE AND DEVELOPED VENTRICULAR FIBRILLATION. CORONARY ANGIOGRAPHY REVEALED COMPLETE OCCLUSION OF THE LEFT MAIN CORONARY ARTERY (LMCA). A LEFT MAIN BALLOON ANGIOPLASTY WAS PERFORMED SEVERAL TIMES, AS WELL AS A THROMBECTOMY WITH NO IMPROVEMENT IN CORONARY BLOOD FLOW. A DRUG-ELUTING STENT WAS PLACED IN THE LMCA WHICH PROVIDED REVASCULARIZATION. ECHOCARDIOGRAPHY DEMONSTRATED VENTRICULAR DISPLACEMENT OF THE PROSTHESIS WITH SEVERE PARAVALVULAR AORTIC REGURGITATION AS THE VALVE WAS UNDERSIZED FOR THE ANNULUS. VIA AORTOTOMY THE BIOPROSTHETIC VALVE WAS EXPLANTED AND A TORN LEAFLET REMOVED. HISTOLOGIC EXAMINATION CONFIRMED THE LEAFLET TO BE A FIBROTIC AND CALCIFIED PORTION OF THE LEFT CORONARY CUSP. A NEW NON-MEDTRONIC BIOPROSTHETIC VALVE WAS SUCCESSFULLY IMPLANTED. POSTOPERATIVE TRANSTHORACIC ECHOCARDIOGRAPHY DEMONSTRATED NO AORTIC INSUFFICIENCY AND NORMAL LEFT VENTRICULAR SYSTOLIC FUNCTION. AT 18-MONTH FOLLOW-UP THE PATIENT WAS STABLE WITH NO NEUROLOGIC DEFICIT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345722 COREVALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION MCS-P3-943

    Patients

    Seq Age Sex Outcome Treatment
    1 00087 YR Life Threatening| R