BEUDAMED
    FDA Adverse Event Death Summary report: N

    DRIVER RX

    MDR report key: 7208637 · Received January 20, 2018

    Report

    Report Number
    9612164-2018-00108
    Event Type
    Death
    Date Received
    January 20, 2018
    Date of Event
    January 1, 2015
    Report Date
    January 20, 2018
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MAF
    PMA / PMN Number
    P030009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    JOURNAL NAME: JOURNAL OF CARDIOVASCULAR MEDICINE AUTHORS: MILOSZ JAGUSZEWSKIA,_, JELENA-RIMA GHADRIA,_, BURKHARDT SEIFERTB, THIERRY HIESTANDA, PAOLA HERRERAA, OLIVER GAEMPERLIA, ULF LANDMESSERA, WILLIBALD MAIERA, BRAHMAJEE K. NALLAMOTHUC, STEPHAN WINDECKERD, THOMAS F. LU¨ SCHERA AND CHRISTIAN TEMPLINA. TITLE OF ARTICLE: DRUG-ELUTING STENTS VS. BARE METAL STENTS IN PATIENTS WITH CARDIOGENIC SHOCK: A COMPARISON BY PROPENSITY SCORE ANALYSIS. LITERATURE REFERENCE: DOI:10.2459/JCM.0000000000000106 YEAR: 2015 ISSUE #:16. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    REPORTED FORM JOURNAL ARTICLE. THE AUTHORS SOUGHT TO ASSESS THE PERFORMANCE OF DRUG-ELUTING STENTS (DES) COMPARED WITH BARE METAL STENTS (BMS) AMONG PATIENTS WITH CARDIOGENIC SHOCK UNDERGOING PERCUTANEOUS CORONARY INTERVENTION (PCI). TWO HUNDRED AND THREE PATIENTS WERE INCLUDED IN THE FINAL ANALYSIS. DES INCLUDED ZOTAROLIMUS-ELUTING STENTS. BMS INCLUDED SKYLOR AND DRIVER STENTS. CULPRIT LESIONS WERE LOCATED IN THE LEFT MAIN, LAD, LCX, RCA AND BYPASS VESSELS. PATIENT OUTCOMES INCLUDED DEATH, MYOCARDIAL INFARCTION, ANY REPEAT REVASCULARIZATION AND STROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52103 DRIVER RX STENT, CORONARY MAF MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death| R