BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE 26MM AORTIC VALVE

    MDR report key: 3900709 · Received June 27, 2014

    Report

    Report Number
    2025587-2014-00428
    Event Type
    Injury
    Date Received
    June 27, 2014
    Date of Event
    June 3, 2014
    Report Date
    January 19, 2018
    Manufacturer
    HEART VALVES SANTA ANA
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONDUCTION DISTURBANCES ARE KNOWN POTENTIAL ADVERSE EFFECTS ASSOCIATED WITH ANY CARDIAC OR THORACIC PROCEDURE (OPEN OR CATHETER-BASED) AND CAN BE RESOLVED WITH MEDICAL TREATMENT OR THE IMPLANT OF A PERMANENT PACEMAKER (WITH THE RISK-BENEFIT RATIO IN FAVOR OF IMPLANT OF THE PERCUTANEOUS AORTIC VALVE). A CONDUCTION DISTURBANCE DOES NOT INDICATE A DEVICE MALFUNCTION OR POTENTIAL MANUFACTURING ISSUE. THE DEVICE REMAINS IMPLANTED. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION REPORTED THAT ATRIAL FIBRILLATION (AFIB) WAS PRESENT WITH THE EPISODE OF ATRIAL FLUTTER FOLLOWING THE IMPLANT OF THE VALVE. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT DURING THE PLACEMENT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE PATIENT EXHIBITED COMPLETE HEART BLOCK. TYPE ONE SECOND-DEGREE HEART BLOCK ALSO WAS NOTED DURING THE PROCEDURE; NO TREATMENT WAS REQUIRED FOR EITHER OF THE ARRHYTHMIA AND THE PATIENT RETURNED TO A SINUS BRADYCARDIA RHYTHM. IT ALSO WAS REPORTED THAT THE PATIENT EXHIBITED ACUTE LEFT BUNDLE BRANCH BLOCK (LBBB) PRIOR TO DEVICE IMPLANT AS A VALVULOPLASTY BALLOON WAS BEING INSERTED AT THE START OF THE IMPLANT PROCEDURE. AN EPISODE OF ATRIAL FLUTTER ALSO WAS OBSERVED POST-IMPLANT AND RESOLVED WITH MEDICATION. SIX MONTHS POST-IMPLANT, THE PATIENT EXHIBITED ALTERNATING RIGHT BUNDLE BRANCH BLOCK (RBBB) AND LBBB AND A PERMANENT PACEMAKER WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377487 COREVALVE 26MM AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT HEART VALVES SANTA ANA MCS-P3-26-AOA

    Patients

    Seq Age Sex Outcome Treatment
    1 00087 YR Other| R