BEUDAMED
    FDA Adverse Event Death Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 7208639 · Received January 20, 2018

    Report

    Report Number
    9612164-2018-00109
    Event Type
    Death
    Date Received
    January 20, 2018
    Date of Event
    January 1, 2015
    Report Date
    January 22, 2018
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: INITIAL MDR SUBMITTED WITH INCORRECT PMA # P030009 REFERENCED INSTEAD OF PMA # P110013. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    COMBINATION PRODUCT NOT SELECTED IN INITIAL MDR. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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/(B)(4) YEAR: 2015 ISSUE #:16. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    REPORTED FROM 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). 203 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
    52129 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death| R