BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT ¿

    MDR report key: 2801990 · Received October 23, 2012

    Report

    Report Number
    2134265-2012-06434
    Event Type
    Injury
    Date Received
    October 23, 2012
    Date of Event
    September 24, 2012
    Report Date
    September 25, 2012
    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 COMBINATION PRODUCT.DEVICE EVALUATED BY MFR: 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 STENTING TREATMENT PROCEDURE, A STENT BECAME ELONGATED. THE TARGET LESION IS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). A NON-BSC GUIDE WIRE WAS ADVANCED TO THE TARGET LESION. THE 2.75 X 28MM PROMUS ELEMENT STENT WAS INTRODUCED AND IMPLANTED. AS THE GUIDE WIRE WAS BEING WITHDRAWN, IT RUBBED AGAINST THE STENT AND IT WAS NOTED THAT THE STENT WAS ELONGATED TO 31 MM. THE ELONGATED STENT WAS TREATED WITH BALLOON ANGIOPLASTY. NO FURTHER 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 ¿ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911328270 15137858

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention