BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT? PLUS

    MDR report key: 3143065 · Received June 3, 2013

    Report

    Report Number
    2134265-2013-03734
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    April 23, 2013
    Report Date
    May 5, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE IS A 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 CORONARY STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY. A 2.50X12MM PROMUS ELEMENT PLUS STENT DELIVERY SYSTEM WAS ATTEMPTED TO ADVANCE INTO THE TARGET LESION BUT IT WAS UNABLE TO CROSS THE LESION. WHEN THEY TOOK THE STENT OUT, THEY NOTED THAT IT WAS BENT. THEY DILATE THE LESION WITH AN UNSPECIFIED BALLOON AND COMPLETED THE PROCEDURE WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE NOTED AND THE PATIENT'S CONDITION WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244159 PROMUS ELEMENT? PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911612250 15912524

    Patients

    Seq Age Sex Outcome Treatment
    1