BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT ¿

    MDR report key: 2840767 · Received November 20, 2012

    Report

    Report Number
    2134265-2012-07103
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Date of Event
    October 25, 2012
    Report Date
    October 25, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. (B)(4). 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 STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE CALCIFIED AND MODERATELY TORTUOUS DISTAL RIGHT CORONARY ARTERY. THE LESION WAS PRE-DILATED WITH AN UNSPECIFIED BALLOON AND THE 3.5 X 28MM PROMUS ELEMENT MR STENT DELIVERY SYSTEM (SDS) WAS ADVANCED BUT WAS UNABLE TO CROSS THE LESION. THE PHYSICIAN ADVANCED AN UNSPECIFIED SMALLER CATHETER FOR SUPPORT, BUT WAS UNABLE TO ADVANCE THE SDS. THE SDS WAS REMOVED FROM THE PATIENT TO DILATE AGAIN, AND IT WAS NOTED THAT THE STENT WAS LIFTED IN THE MIDDLE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS ELEMENT ¿ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911328350 15276341

    Patients

    Seq Age Sex Outcome Treatment
    1