BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT ¿ LONG

    MDR report key: 2862114 · Received December 7, 2012

    Report

    Report Number
    2134265-2012-07350
    Event Type
    Injury
    Date Received
    December 7, 2012
    Date of Event
    October 23, 2012
    Report Date
    November 8, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE CLASSIFICATION OF THIS INVESTIGATION IS CAUSED BY OTHER DEVICE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ANGIOPLASTY STENTING TREATMENT PROCEDURE FOR A CHRONIC OCCLUSION, STENT DAMAGE OCCURRED. THE PROMUS ELEMENT 3.50X38MM WAS IMPLANTED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). A SECOND STENT PROMUS ELEMENT 3.0X38MM WAS DEPLOYED. DURING THE ADVANCEMENT OF A 3RD PROMUS ELEMENT STENT SIZE 2.5X24MM THE 3.5X38MM WAS DEFORMED. IT WAS NOT POSSIBLE TO DEPLOY THE 3RD PROMUS ELEMENT STENT 2.5X24MM. A NEARLY 10MM LONGITUDINAL DEFORMATION WAS NOTICED ON THE PROMUS ELEMENT 3.50X38MM. THE PHYSICIAN USED AN UNSPECIFIED BALLOON TO IMPROVE THE POSITION OF THE DAMAGED STENT SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS ELEMENT ¿ LONG STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911338350 0014675304

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention