BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE

    MDR report key: 4639273 · Received March 27, 2015

    Report

    Report Number
    2025587-2015-00376
    Event Type
    Injury
    Date Received
    March 27, 2015
    Date of Event
    March 4, 2015
    Report Date
    May 26, 2015
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, 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 ASSOCIATED WITH ANY CARDIAC OR THORACIC PROCEDURE (OPEN OR C ATHETER-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 MANUF ACTURING ISSUE. (B)(4).

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER ADDED TO THIS REPORT. PRODUCT CODE AND COMMON DEVICE NAME FIELDS CORRECTED FROM LWR TO NPT.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE PATIENT'S WEIGHT WAS (B)(6).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, AN ELECTROCARDIOGRAM (ECG) INDICATED COMPLETE HEART BLOCK. SUBSEQUENTLY, A PERMANENT PACEMAKER WAS IMPLANTED ONE DAY AFTER THE IMPLANT OF THE VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204661 COREVALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION MCS-P4-23-AOA

    Patients

    Seq Age Sex Outcome Treatment
    1 00082 YR Required Intervention