BEUDAMED
    FDA Adverse Event Death Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 5731605 · Received June 17, 2016

    Report

    Report Number
    9612164-2016-00597
    Event Type
    Death
    Date Received
    June 17, 2016
    Date of Event
    June 10, 2015
    Report Date
    May 18, 2016
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). JOURNAL ARTICLE REFERENCE: KIM, B-K ET AL. CLINICAL IMPACT OF INTRAVASCULAR ULTRASOUND¿GUIDED CHRONICTOTAL OCCLUSION INTERVENTION WITH ZOTAROLIMUS-ELUTING VERSUS BIOLIMUS-ELUTING STENT IMPLANTATION: RANDOMIZED STUDY. CIRC CARDIOVASC INTERV. 2015;8:E002592. DOI:10.1161/CIRCINTERVENTIONS.115.002592. DATE OF EVENT = DATE JOURNAL ARTICLE WAS ACCEPTED.

    Additional Manufacturer Narrative · 1

    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

    BETWEEN (B)(6) 2012 AND (B)(6) 2013, PATIENT WAS ENROLLED AND RANDOMIZED FOR TREATMENT AFTER SUCCESSFUL GUIDE WIRE-CROSSING OF THE CTO LESION, IN A COMPARISON STUDY BETWEEN IVUS-GUIDED GROUP AND THE ANGIO-GUIDED GROUP. DURING THE PROCEDURE, THE PATIENT HAD TWO OVERLAPPING RESOLUTE INTEGRITY DRUG-ELUTING STENTS IMPLANTED IN THE RCA. APPROXIMATELY 279 DAYS POST PROCEDURE THAT PATIENT HAD CHEST PAIN AND ON ARRIVAL AT ER, HAD CPR BUT DEATH OCCURRED. CARDIAC DEATH OCCURRED ONLY IN THE ANGIOGRAPHY-GUIDED GROUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387021 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death| H| R