BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE

    MDR report key: 3811380 · Received May 15, 2014

    Report

    Report Number
    2025587-2014-00287
    Event Type
    Injury
    Date Received
    May 15, 2014
    Date of Event
    February 19, 2014
    Report Date
    April 22, 2014
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: THE PRODUCT REMAINS IMPLANTED AND THEREFORE HAS NOT BEEN RETURNED TO MEDTRONIC. DEVICE HISTORY REVIEW IS NOT REQUIRED AS THE EVENT DESCRIPTION DOES NOT INDICATE A POTENTIAL MANUFACTURING ISSUE. CONDUCTION DISTURBANCES ARE KNOWN POTENTIAL ADVERSE EFFECTS PER THE INSTRUCTIONS FOR USE (IFU) AND CAN BE RESOLVED WITH THE IMPLANT OF A PERMANENT PACEMAKER WITH THE RISK-BENEFIT RATIO IN FAVOR OF THE PERCUTANEOUS AORTIC VALVE (PAV). (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 DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, AFTER POST-BALLOON AORTIC VALVULOP LASTY (BAV), LEFT BUNDLE BRANCH BLOCK (LBBB) WAS NOTED. IMMEDIATE POST-PROCEDURE ELECTROCARDIOGRAM (ECG) REVEALED ATRIAL FIBRILLATION (AFIB) WITH SLOW VENTRICULAR RESPONSE WITH OCCASIONAL VENTRICULAR PACED COMPLEXES, BUT NO LBBB. THE MOST RECENT ECG INDICATES AFIB WITH INCOMPLETE RIGHT BUNDLE BRANCH BLOCK. NO TREATMENT PRESCRIBED. FIVE WEEKS POST-IMPLANT THE PATIENT WAS HOSPITALIZED FOR AN ISOLATED EVENT OF NEAR SYNCOPE WITHOUT PREMONITION. ALTHOUGH THE PATIENT WAS STABLE FOR DISCHARGE, A TRANSFER TO ANOTHER HOSPITAL WAS MADE, WHERE THE PATIENT RECEIVED A DIAGNOSIS OF SYMPTOMATIC BRADYCARDIA. SEVEN WEEKS POST-IMPLANT A PERMANENT PACEMAKER WAS PLACED,WHICH RESOLVED THE CONDUCTION DISTURBANCES. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290911 COREVALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION MCS-P3-3143

    Patients

    Seq Age Sex Outcome Treatment
    1 00090 YR Required Intervention