BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE

    MDR report key: 3629108 · Received February 14, 2014

    Report

    Report Number
    2025587-2014-00037
    Event Type
    Injury
    Date Received
    February 14, 2014
    Date of Event
    January 18, 2014
    Report Date
    June 26, 2014
    Manufacturer
    MEDTRONIC COREVALVE LLC
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SUBSEQUENTLY THE ANGIOGRAPHIC RECORD AND THE CLINICAL EXECUTIVE SUMMARY REPORT WERE PROVIDED FOR REVIEW. THE ANGIO SHOWED THE PATIENT HAD SMALL AORTIC ROOT ANATOMY AND THE VALVE DID NOT APPEAR TO BE FULLY EXPANDED (THE VALVE WAS CYLINDRICAL IN SHAPE). THE PATIENT HAS A SMALL SINUS OF VALSALVA (SOV), A 23 MILLIMETER (MM) ANNULUS, AND THE LEFT CORONARY ARTERY TAKEOFF IS 1 MM FROM THE BOTTOM. THE ANGIOGRAPHIC RECORD CONFIRMED THE COMPLAINT AS THE RECORD BEGINS WITH THE IMPLANTED VALVE AND A LEFT CORONARY OCCLUSION, AND SHOWS A LEFT CORONARY INTERVENTION TO RESOLVE THE OCCLUSION. THE DECREASED FLOW WAS NOTED AS DUE TO THE DEVICE PUSHING THE NATIVE LEAFLET INTO THE LEFT CORONARY SINUS; THIS APPEARED TO BE DUE TO PATIENT ANATOMY AND IMPLANT TECHNIQUE AND DOES NOT INDICATE A DEVICE FAILURE OR MALFUNCTION. THE SIZING INFORMATION IN THE SUMMARY SHOWS THAT A SMALLER SIZE VALVE MAY HAVE BEEN THE MORE APPROPRIATE SIZE VALVE TO IMPLANT. IT IS UNKNOWN WHY THIS SIZE VALVE WAS CHOSEN FOR IMPLANT. THE PATIENT'S SMALL ANATOMY WITH THE SMALL SOV LIKELY CONTRIBUTED TO THE NATIVE LEAFLET FILLING THE LEFT CORONARY SINUS AND OCCLUDING THE ARTERY. THE VALVE¿S 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.

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: THE DEVICE REMAINS IMPLANTED. CONCLUSION: WITHOUT RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSIONS COULD BE DRAWN REGARDING THE CLINICAL OBSERVATION. THE ANGIOGRAPHIC PROCEDURAL FILMS HAVE BEEN REQUESTED BUT NOT RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    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 ONE DAY FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, S-T CHANGES ON THE ELECTROCARDIOGRAM (ECG) AND HYPOTENSION WERE NOTED. CATH LAB PROCEDURE CONFIRMED DECREASED FLOW TO THE LEFT CORONARY ARTERY DUE TO THE COREVALVE PUSHING THE NATIVE LEAFLET INTO THE LEFT CORONARY SINUS, PARTIALLY OBSTRUCTING THE LEFT MAIN OSTIUM. THE COREVALVE ITSELF WAS NOT DIRECTLY IMPACTING THE LEFT CORONARY ARTERY. A CORONARY STENT WAS PLACED IN THE LEFT MAIN CORONARY OSTIUM. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97394 COREVALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC COREVALVE LLC MCS-P3-943

    Patients

    Seq Age Sex Outcome Treatment
    1 00083 YR Required Intervention