BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 6568429 · Received May 16, 2017

    Report

    Report Number
    9612164-2017-00592
    Event Type
    Injury
    Date Received
    May 16, 2017
    Date of Event
    February 26, 2017
    Report Date
    April 17, 2017
    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

    COM CODE (B)(4) AUTHORS SHOICHI KURAMITSU1, TAKASHI HIROMASA1, HIROYUKI JINNOUCHI1, TAKENORI DOMEI1, SHINICHI SHIRAI1, KENJI ANDO1, JOURNAL NAME: CARDIOVASC INTERV AND THER YEAR 2017 ISSUE # 32:154¿158. TITLE OF ARTICLE USEFULNESS OF ROTATIONAL ATHERECTOMY WITH OPTICAL FREQUENCY, LITERATURE REFERENCE DOI 10.1007/S12928-016-0382-4. 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.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A RESOLUTE INTEGRITY RX DRUG ELUTING STENT WAS IMPLANTED IN THE PROXIMAL LAD. SEVEN DAYS POST INDEX PROCEDURE, PATIENT WAS PRESENTED WITH CHEST PAIN AND ST ELEVATION. CAG REVEALED TOTAL OCCLUSION WITHIN THE STENT WHICH WAS DIAGNOSED AS EARLY STENT THROMBOSIS. THROMBUS ASPIRATION WAS CARRIED OUT WHICH RESTORED CORONARY FLOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350054 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention