BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT? PLUS

    MDR report key: 3173417 · Received June 17, 2013

    Report

    Report Number
    2134265-2013-04211
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    May 23, 2013
    Report Date
    May 23, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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; 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 INTERVENTION, A DISTAL STENT DAMAGED OCCURRED. THE UNSPECIFIED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND SEVERELY TORTUOUS LEFT CIRCUMFLEX ARTERY. A 2.25X12MM PROMUS ELEMENT PLUS STENT DELIVERY SYSTEM WAS SELECTED TO TREAT THE LESION. AFTER THE PHYSICIAN PERFORMED PRE DILATATION WITH AN UNSPECIFIED BALLOON CATHETER, THIS DEVICE WAS ATTEMPTED TO ADVANCED INTO THE TARGET LESION BUT IT COULD NOT CROSS THE LESION. WHEN THE STENT WAS REMOVED FROM THE PATIENT'S BODY, A DISTAL SECTION OF THE DEVICE WAS FOUND TO BE LIFTED. THE PROCEDURE WAS COMPLETED WITH POBA (PLAIN OLD BALLOON ANGIOPLASTY), WITHOUT STENTING. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274317 PROMUS ELEMENT? PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493918412220 15664257

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR: RF-3000