BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVER RX CORONARY STENT SYSTEM

    MDR report key: 2080578 · Received April 22, 2011

    Report

    Report Number
    9612164-2011-00276
    Event Type
    Injury
    Date Received
    April 22, 2011
    Date of Event
    July 14, 2009
    Report Date
    March 26, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MAF
    PMA / PMN Number
    P030009
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULT: (REVASCULARISATION).

    Description of Event or Problem · 1

    TWO LESIONS WERE TREATED DURING THE INDEX PROCEDURE. ONE NON-MEDTRONIC STENT WAS IMPLANTED IN THE PROX LAD AND ONE DRIVER STENT WAS IMPLANTED IN THE LEFT MAIN. THE PT WAS DISCHARGED THE DAY FOLLOWING THE INDEX PROCEDURE. PT HAD CARDIAC STATUS OF STABLE ANGINA AT THE 30 DAY F/U AND WAS ASYMPTOMATIC AT THE 6 MONTH F/U. APPROX 1 YR POST INDEX PROCEDURE, THREE LESIONS WERE REVASCULARISED. ONE ENDEAVOR RESOLUTE RX DRUG ELUTING STENT WAS IMPLANTED IN THE MID LAD AND ONE NON-MEDTRONIC STENT WAS IMPLANTED IN EACH OF THE RIGHT PDA AND DISTAL LAD. THE INVESTIGATOR STATED THAT ALL WERE TARGET VESSELS AND THAT THE REVASCULARIZATION EVENT WAS NOT RELATED TO THE STUDY STENT OR PROCEDURE. PT HAD CARDIAC STATUS OF STABLE ANGINA AT THE 1 YR F/U, WAS ASYMPTOMATIC AT THE 1.5 YR F/U, HAD CARDIAC STATUS OF STABLE ANGINA AT THE 2 YR F/U AND CARDIAC STATUS OF UNSTABLE ANGINA AT THE 2.5 YR F/U.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRIVER RX CORONARY STENT SYSTEM MAF MEDTRONIC IRELAND NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention ASPIRIN| CLOPIDOGREL