BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS? ELEMENT?

    MDR report key: 3881951 · Received June 18, 2014

    Report

    Report Number
    2134265-2014-03452
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    May 22, 2014
    Report Date
    May 23, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE IS A COMBINATION PRODUCT. (B)(4). DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE 100% STENOSED LESION IS LOCATED IN THE MODERATELY TORTUOUS MID RIGHT CORONARY ARTERY (RCA). AN UNSPECIFIED GUIDE WIRE ADVANCED TO THE LESION. THROMBECTOMY WAS PERFORMED WITH A UNSPECIFIED CATHETER. PREDILATION WAS PERFORMED WITH AN UNSPECIFIED SEMI-COMPLIANCE BALLOON CATHETER. A 28MM X 3.50MM TAXUS¿ ELEMENT¿ STENT WAS SELECTED TO TREAT THE LESION HOWEVER, THE DEVICE WAS UNABLE TO CROSS THE TARGET LESION. WHEN THE DEVICE WAS REMOVED FROM THE PATIENT, IT WAS FOUND THAT A STENT STRUT WAS PARTIALLY LIFTED APPROXIMATELY 2 MM FROM THE DISTAL EDGE OF THE STENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATION WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357251 TAXUS? ELEMENT? CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493902528350 16200552

    Patients

    Seq Age Sex Outcome Treatment
    1 INFLATION DEVICE:EVEREST