BEUDAMED
    FDA Adverse Event Death Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 6553594 · Received May 9, 2017

    Report

    Report Number
    9612164-2017-00571
    Event Type
    Death
    Date Received
    May 9, 2017
    Date of Event
    March 16, 2017
    Report Date
    April 11, 2017
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DATE IS DATE JOURNAL WAS AVAILABLE ONLINE. JOURNAL ARTICLE: COMPARING STENT THROMBOSIS ASSOCIATED WITH ZOTAROLIMUS ELUTING STENTS VERSUS EVEROLIMUS ELUTING STENTS AT 1 YEAR FOLLOW UP: A SYSTEMATIC REVIEW AND META-ANALYSIS OF 6 RANDOMIZED CONTROLLED TRIALS LITERATURE REFERENCE: BUNDHUN ET AL. BMC CARDIOVASCULAR DISORDERS (2017) 17:84 DOI 10.1186/S12872-017-0515-4. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT 10,512 PATIENTS WERE INCLUDED IN ANALYSIS. ELECTRONIC DATABASE WERE SEARCHED FOR STUDIES COMPARING ZOTAROLIMUS ELUTING STENTS (ZES) VERSUS EVEROLIMUS ELUTING STENTS (EES) REGARDING STENT THROMBOSIS. ADVERSE EVENTS NOTED DURING REVIEW INCLUDED CARDIAC DEATH, TARGET LESION AND VESSEL REVASCULARIZATION, TARGET LESION FAILURE, MI, CEREBROVASCULAR ACCIDENT / STROKE, AND STENT THROMBOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334803 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 Death