BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT ?

    MDR report key: 3935017 · Received July 15, 2014

    Report

    Report Number
    2134265-2014-04079
    Event Type
    Injury
    Date Received
    July 15, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 18, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 FORESHORTENING OCCURRED. THE 80% STENOSED, 20X4.5MM, ECCENTRIC AND DE NOVO TARGET LESION WAS LOCATED IN A MODERATELY CALCIFIED AND MODERATELY TORTUOUS RIGHT CORONARY ARTERY. FOLLOWING PREDILATION WITH AN UNSPECIFIED BALLOON CATHETER, A 4.00X20MM PROMUS ELEMENT ¿ DRUG-ELUTING STENT WAS DEPLOYED TO TREAT THE TARGET LESION. HOWEVER, IT WAS NOTICED THAT THE STENT GOT SEVERELY SHORTENED AND COULD NOT FULLY COVER THE LESION. THE PROCEDURE WAS THEN COMPLETED BY DEPLOYING ANOTHER OF THE SAME DEVICE TO COVER THE LESION. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412743 PROMUS ELEMENT ? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911320400 16166406

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention BMW- GUIDEWIRE