BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE 23MM AORTIC VALVE

    MDR report key: 3631548 · Received February 18, 2014

    Report

    Report Number
    2025587-2014-00040
    Event Type
    Injury
    Date Received
    February 18, 2014
    Date of Event
    January 20, 2014
    Report Date
    July 24, 2014
    Manufacturer
    MEDTRONIC COREVALVE LLC
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    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)(6). (B)(4).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT FOLLOWING THE SUCCESSFUL IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE FINAL ANGIOGRAM REVEALED A PART OF THE NATIVE LEAFLET OR CALCIUM WAS PARTIALLY OBSTRUCTING THE OSTIUM OF LEFT MAIN CORONARY ARTERY, CAUSING S-T ELEVATION ON THE ELECTROCARDIOGRAM (ECG). CORONARY ANGIOPLASTY WAS PERFORMED BEFORE PLACING A CORONARY STENT INTO THE LEFT MAIN CORONARY ARTERY. THE ECG RETURNED TO NORMAL AND ANGIOGRAPHY POST-STENT PLACEMENT CONFIRMED GOOD FLOW IN THE ARTERY. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    SUBSEQUENTLY THE CLINICAL STUDY SITE REPORTED THAT THE LEFT MAIN CORONARY ARTERY IMPINGEMENT WAS DUE TO THE "SMALL SINOTUBULAR RIM AND SIZE OF VALVE", NO ADDITIONAL TREATMENT BEYOND THE STENT PLACEMENT OCCURRED, AND THE PATIENT WAS REPORTED AS RECOVERED ONE WEEK AFTER THE IMPINGEMENT/STENT PLACEMENT. THE DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101951 COREVALVE 23MM AORTIC VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE NPT MEDTRONIC COREVALVE LLC MCS-P3-2334

    Patients

    Seq Age Sex Outcome Treatment
    1 00091 YR Required Intervention