BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

    MDR report key: 2111621 · Received June 2, 2011

    Report

    Report Number
    2134265-2011-01916
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    May 5, 2011
    Report Date
    May 5, 2011
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT - 18 YEARS OR OLDER. DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER - THE COMPLAINT DEVICE WAS NOT RECEIVED FOR ANALYSIS. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A VESSEL DISSECTION OCCURRED. TWO LESIONS WERE BEING TREATED. THE 80% STENOSED, DIFFUSE LESION BEING TREATED WAS LOCATED IN THE MILDLY TORTUOUS, SEVERELY CALCIFIED MID RIGHT CORONARY ARTERY (RCA) AND THE 95% STENOSED LESION BEING TREATED WAS LOCATED IN THE OSTIAL RCA. THERE WAS AN 8MM GAP BETWEEN THE LESIONS. THE LESIONS WERE NOT PREDILATED. A 3.50X28MM ION STENT WAS DEPLOYED, AT 16ATM, IN THE MID RCA. THEN A 3.50X8MM ION STENT WAS DEPLOYED, AT 18ATM, IN THE OSTIAL RCA. IVUS WAS PERFORMED AND IDENTIFIED A TYPE B DISSECTION IN THE PROXIMAL PORTION OF THE 3.50X28MM ION STENT. THE PHYSICIAN TREATED THE DISSECTION WITH A 3.50X12MM ION STENT. PHYSICIAN WAS HAPPY WITH THE RESULT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ H7493902428350

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention