BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE

    MDR report key: 4182201 · Received October 17, 2014

    Report

    Report Number
    2025587-2014-00772
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    September 23, 2014
    Report Date
    December 5, 2014
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT¿S SINUS OF VALSALVA WAS VERY SMALL; HOWEVER, IT IS UNCLEAR WHETHER THE OCCLUSION WAS RELATED TO PATIENT CONDITION/ANATOMY AS WAS REPORTED. IT CANNOT BE DETERMINED FROM THE AVAILABLE INFORMATION IF THE VALVE WAS ULTIMATELY PLACED HIGHER THAN INTENDED AS NO PROCEDURAL VIDEO IMAGES WERE SUBMITTED FOR ANALYSIS. THIS TYPE OF ISSUE IS GENERALLY DUE TO PATIENT ANATOMY AND/OR IMPLANT TECHNIQUE. FROM THE AVAILABLE INFORMATION A CONCLUSIVE CAUSE FOR THE OCCLUSION COULD NOT BE DETERMINED. NO ALLEGATIONS WERE MADE AGAINST THE DEVICE, AND THERE WAS NO INDICATION THAT A MALFUNCTION OR MISUSE CONTRIBUTED TO THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE PRODUCT REMAINS IMPLANTED AND THEREFORE HAS NOT BEEN RETURNED TO MEDTRONIC. (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS PRODUCT MET ALL MANUFACTURING SPECIFICATIONS FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT FOLLOWING IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC HEART VALVE, AN ANGIOGRAM SHOWED NORMAL BLOOD FLOW. THIRTY MINUTES POST-IMPLANT, THE PATIENT EXHIBITED ST SEGMENT DEPRESSION ON AN ELECTROCARDIOGRAM. AN ECHOCARDIOGRAM SHOWED REDUCED CONTRACTILITY OF THE LEFT VENTRICLE, AND AN ANGIOGRAM CONFIRMED PARTIAL LEFT CORONARY OCCLUSION. A CORONARY ARTERY BYPASS SURGERY WAS PERFORMED TO ENSURE LEFT CORONARY ARTERY FLOW. NO SUBSEQUENT ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661572 COREVALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION MCS-P3-640

    Patients

    Seq Age Sex Outcome Treatment
    1 00084 YR Life Threatening