BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE 29MM AORTIC VALVE

    MDR report key: 3895592 · Received June 25, 2014

    Report

    Report Number
    2025587-2014-00418
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    May 30, 2014
    Report Date
    June 1, 2014
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: THE PRODUCT REMAINS IMPLANTED AND THEREFORE HAS NOT BEEN RETURNED TO MEDTRONIC. 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.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT 2 DAYS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, ANEMIA RELATED TO PROCEDURAL BLOOD LOSS WAS NOTED. TWO UNITS OF BLOOD WERE TRANSFUSED AND THE ISSUE RESOLVED. THREE DAYS FOLLOWING IMPLANT, COMPLETE HEART BLOCK AND VENTRICULAR STANDSTILL WERE NOTED, REQUIRING 30 SECOND OF CARDIOPULMONARY RESUSCITATION (CPR). A TEMPORARY PACEMAKER WAS PLACED VIA THE RIGHT FEMORAL VEIN. FIVE DAYS POST-VALVE IMPLANT A DUAL CHAMBER PERMANENT PACEMAKER WAS IMPLANTED IN THE LEFT SUBCLAVIAN AREA, RESOLVING THE CONDUCTION DISTURBANCE. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371507 COREVALVE 29MM AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION MCS-P3-29-AOA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention