BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT ¿

    MDR report key: 2834460 · Received November 15, 2012

    Report

    Report Number
    2134265-2012-06900
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Date of Event
    October 18, 2012
    Report Date
    October 18, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. (B)(4). AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE EVALUATED BY MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. 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 DURING A PERCUTANEOUS CORONARY INTERVENTION, STENT DAMAGE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE CALCIFIED AND MODERATELY TORTUOUS DISTAL LEFT CIRCUMFLEX (LCX). THE LESION WAS PRE-DILATED WITH ANOTHER MANUFACTURER'S 2.0 X 15 MM BALLOON CATHETER AND A 2.25 X 20 MM PROMUS ELEMENT PLUS STENT WAS IMPLANTED. THE PHYSICIAN THEN WANTED TO IMPLANT A PROMUS ELEMENT, MR, OUS 2.50 X 12 MM STENT OVERLAPPING THE PREVIOUS STENT PROXIMALLY. THE STENT DELIVERY SYSTEM WAS ADVANCED, BUT THE DEVICE WAS UNABLE TO CROSS THE LESION DUE TO THE CALCIFICATION AND IT WAS NOTED THAT THE STENT BECAME "FLARED". THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENTS CONDITION WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS ELEMENT ¿ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911312250 15054821

    Patients

    Seq Age Sex Outcome Treatment
    1 2.0 X 15 MM IKAZUCHI BALLOON CATHETER| EVEREST INFLATION DEVICE| ELITE AVJ GUIDEWIRE| 6F TERUMO INTRODUCER SHEATH