BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE

    MDR report key: 3851434 · Received June 5, 2014

    Report

    Report Number
    2025587-2014-00353
    Event Type
    Injury
    Date Received
    June 5, 2014
    Date of Event
    May 8, 2014
    Report Date
    May 12, 2014
    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

    PRODUCT ANALYSIS: THE DEVICE REMAINS IMPLANTED, THEREFORE NO PRODUCT ANALYSIS CAN BE PERFORMED. CONCLUSION: CONDUCTION DISTURBANCES ARE KNOWN POTENTIAL ADVERSE EFFECTS AND CAN BE RESOLVED WITH THE IMPLANT OF A PERMANENT PACEMAKER WITH THE RISK-BENEFIT RATIO IN FAVOR OF IMPLANT OF THE PERCUTANEOUS AORTIC VALVE. ACCORDING TO LITERATURE REVIEW AND THE VALVE ACADEMIC RESEARCH CONSORTIUM (VARC), THE CLOSE ANATOMICAL RELATIONSHIP BETWEEN THE AORTIC VALVE COMPLEX AND THE BRANCHING ATRIOVENTRICULAR BUNDLE MAY PROVIDE AN EXPLANATION FOR THESE COMPLICATIONS OF THE PROCEDURE. OTHER FACTORS THAT COULD CONTRIBUTE TO THE ONSET OF CONDUCTION DEFECTS INCLUDE UNDERLYING HEART DISEASE, ELECTROLYTE DISTURBANCES AND CERTAIN MEDICATIONS (I.E. BETA BLOCKERS, CALCIUM CHANNEL BLOCKERS). IN THIS CASE, THE EXACT CAUSE OF THE CLINICAL OBSERVATION CANNOT BE CONFIRMED. (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 FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE PATIENT DEVELOPED LEFT BUNDLE BRANCH BLOCK (LBBB). NO TREATMENT WAS PRESCRIBED AND THE CONDITION REMAINED ONGOING. THREE DAYS POST IMPLANT THE PATIENT DEVELOPED COMPLETE HEART BLOCK. SUBSEQUENTLY A PERMANENT PACEMAKER WAS IMPLANTED WITH NO ADVERSE PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328665 COREVALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT HEART VALVES SANTA ANA MCS-P3-3143

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR Required Intervention