BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 7959619 · Received October 12, 2018

    Report

    Report Number
    9612164-2018-02721
    Event Type
    Injury
    Date Received
    October 12, 2018
    Date of Event
    August 24, 2018
    Report Date
    October 12, 2018
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    JOURNAL ARTICLE TITLE: ASSOCIATION OF SUBCLINICAL INTRASTENT THROMBUS DETECTED 9 MONTHS AFTER IMPLANTATION OF 2ND-GENERATION DRUG-ELUTING STENT WITH FUTURE MAJOR ADVERSE CARDIAC EVENTS: A CORONARY ANGIOSCOPIC STUDY AUTHORS: SHOTA OKUNO, MD; TAKAYUKI ISHIHARA, MD; OSAMU IIDA, MD; MITSUTOSHI ASAI, MD, PHD; MASAHARU MASUDA, MD, PHD; SHIN OKAMOTO, MD; KIYONORI NANTO, MD; TAKASHI KANDA, MD; TAKUYA TSUJIMURA, MD; YASUHIRO MATSUDA, MD; MITSUYOSHI TAKAHARA, MD, PHD; MASAAKI UEMATSU, MD, PHD; TOSHIAKI MANO, MD, PHD PUBLICATION: CIRCULATION JOURNAL ISSUE #: 82: 2299 ¿ 2304 YEAR: 2018 LITERATURE REFERENCE #: DOI: 10.1253/CIRCJ.CJ-18-0098. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A STUDY WAS CARRIED OUT INVOLVING PATIENTS WHO RECEIVED RESOLUTE INTEGRITY DRUG ELUTING STENTS. COLLECTIVE VESSELS TREATED INCLUDED THE LAD, LCX AND RCA. IT WAS REPORTED THAT ADVERSE EVENTS INCLUDED MAJOR ADVERSE CARDIAC EVENTS (M.A.C.E) COMPRISING OF DEATH, ACUTE MI AND REVASCULARISATION . INSTENT THROMBUS ALSO REPORTED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    802233 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention