BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 6947349 · Received October 13, 2017

    Report

    Report Number
    9612164-2017-01462
    Event Type
    Injury
    Date Received
    October 13, 2017
    Date of Event
    February 15, 2016
    Report Date
    September 15, 2017
    Manufacturer
    MEDTRONIC
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AUTHORS: MICHAEL A. GAGLIA JR, REBECCA TORGUSON, MICHAEL J. LIPINSKI, JIAXIANG GAI, EDWARD KOIFMAN, SARKIS KIRAMIJYAN, SMITA NEGI, TOBY ROGERS, ARIE STEINVIL, WILLIAM O. SUDDATH, LOWELL F. SATLER, AUGUSTO D. PICHARD, AND RON WAKSMAN. JOURNAL: THE AMERICAN JOURNAL OF CARDIOLOGY YEAR: 2016 VOL. 117 ISSUE 4 TITLE: FREQUENCY OF ANGINA PECTORIS AFTER PERCUTANEOUS CORONARY INTERVENTION AND THE EFFECT OF METALLIC STENT TYPE REF: HTTP://DX.DOI.ORG/10.1016/J.AMJCARD.2015.11.036 CONTINUED FROM (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2715 PATIENTS HAD 2ND GENERATION DES IMPLANTED INCLUDING RESOLUTE (ZOTAROLIMUS ELUTING STENT). THE OCCURRENCE OF MAJOR ADVERSE EVENTS AT 1 YEAR WAS RECORDED; THIS INCLUDED ALL-CAUSE MORTALITY, ANGINA, Q-WAVE MYOCARDIAL INFARCTION, TARGET VESSEL REVASCULARISATION (TVR) , STENT THROMBOSIS AND MAJOR ADVERSE CARDIAC EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727781 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention