BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT PRO TRANSCATHETER AORTIC VALVE

    MDR report key: 6736071 · Received July 24, 2017

    Report

    Report Number
    2025587-2017-01224
    Event Type
    Injury
    Date Received
    July 24, 2017
    Date of Event
    June 29, 2017
    Report Date
    June 29, 2017
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    UDI-DI
    00643169954458
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: THE PRODUCT REMAINS IMPLANTED, THEREFORE NO PRODUCT ANALYSIS CAN BE PERFORMED. CONCLUSION: 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. WITHOUT RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSIONS COULD BE DRAWN REGARDING THE CLINICAL OBSERVATION.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, WHEN AT 80% DEPLOYMENT, THE VALVE MOVED VENTRICULAR FROM A DEPTH OF 4 MM TO ABOUT 12-15 MM. AN ELECTROCARDIOGRAM (ECG) INDICATED COMPLETE HEART BLOCK (CHB). SUBSEQUENT LY, A SECOND TRANSCATHETER BIOPROSTHETIC VALVE WAS IMPLANTED ALONG WITH A PERMANENT PACEMAKER. IT WAS REPORTED THE AORTIC ROOT ANGLE WAS ABOUT 59 DEGREES WITH TORTUROUS FEMORAL VESSELS, WHICH CAUSED TENSION IN THE DELIVERY CATHETER SYSTEM (DCS). NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    517120 EVOLUT PRO TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION EVOLUTPRO-29-US 00643169954458

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention