BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT ¿

    MDR report key: 3081041 · Received April 26, 2013

    Report

    Report Number
    2134265-2013-02647
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    March 29, 2013
    Report Date
    April 1, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. (B)(4). 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. VASCULAR ACCESS WAS GAINED VIA THE FEMORAL ARTERY. THE 2.5X12-24MM, ECCENTRIC AND PROGRESSIVE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH A SIGNIFICANT BEND BETWEEN 45 AND 90 DEGREES. THE LESION WAS PRE-DILATED WITH A 1.5X20MM, 2.0X20MM, AND 2.5X20MM MAVERICK BALLOONS. THE 2.25X24MM PROMUS ELEMENT STENT WAS ADVANCED HOWEVER WAS UNABLE TO CROSS THE LESION. THE DEVICE WAS REMOVED AND THE LESION WAS DILATED AND THE DEVICE WAS ADVANCED AGAIN, HOWEVER WAS STILL UNABLE TO CROSS THE LESION. UPON REMOVAL IT WAS NOTED THAT THE STENT WAS DEFORMED. THE PROCEDURE WAS NOT COMPLETED DUE TO ANOTHER REASON. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182955 PROMUS ELEMENT ¿ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911324220 0015817489

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR BALLOON CATHETER: 1.5X20MM MAVERICK| GUIDE WIRE: PT2| GUIDE CATHETER: JL4 6F| BALLOON CATHETER: 2.0X20MM MAVERICK| BALLOON CATHETER: 2.5X20MM MAVERICK