BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT ?

    MDR report key: 4222619 · Received November 4, 2014

    Report

    Report Number
    2134265-2014-06760
    Event Type
    Malfunction
    Date Received
    November 4, 2014
    Date of Event
    October 14, 2014
    Report Date
    October 15, 2014
    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. 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. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE 80% STENOSED, 16X3.5MM, ECCENTRIC, DE NOVO TARGET LESION CONTAINED >45 AND <90 DEGREE BEND AND WAS LOCATED IN THE MODERATELY CALCIFIED MID RIGHT CORONARY ARTERY (RCA). FOLLOWING THE INSERTION OF A NON-BSC GUIDE CATHETER AND THE ADVANCEMENT OF AN UNSPECIFIED SIZE PT2LS GUIDE WIRE, PREDILATION WAS PERFORMED WITH A 2.5X15MM NON BSC BALLOON CATHETER RESULTING TO 40% RESIDUAL STENOSIS. SUBSEQUENTLY, A 2.75X12MM PROMUS ELEMENT ¿ DRUG ELUTING STENT WAS SELECTED FOR USE AND ADVANCED BUT FAILED TO CROSS THE LESION. THE DEVICE WAS REMOVED AND THE PHYSICIAN NOTICED THAT THE TIP OF THE STENT WAS DEFORMED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705549 PROMUS ELEMENT ? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911312270 16963824

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR JR4= GUIDE CATHETER| PT2LS= GUIDE WIRE| TRAK 2.5/15= BALLOON