BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT¿ PLUS

    MDR report key: 3040216 · Received April 8, 2013

    Report

    Report Number
    2134265-2013-02100
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 12, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE IS 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 STENTING TREATMENT PROCEDURE, STENT DEFORMATION OCCURRED AND THE PATIENT EXPERIENCED ST ELEVATION. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. THE 4.0X20MM PROMUS ELEMENT PLUS CORONARY DRUG-ELUTING STENT WAS DEPLOYED IN THE LESION TO 13ATMS. UPON REMOVAL OF THE STENT DELIVERY SYSTEM (SDS), MID LONGITUDINAL STENT DEFORMATION WAS NOTED. THE PHYSICIAN FELT THIS WAS CAUSED BY THE BALLOON CATCHING ON THE STENT; HOWEVER RESISTANCE WAS NOT NOTED. THE BALLOON WAS REMOVED INTACT. ST ELEVATION WAS NOTED ON ECG. A 4.0X6.0MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED TO TREAT THE STENT DEFORMATION. THE STENT APPEARED WELL APPOSED ON X-RAY, BUT THE ST ELEVATION WAS NOT RESOLVED. MORPHINE WAS ADMINISTERED WHICH DID RESOLVE THE ISSUE. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143419 PROMUS ELEMENT¿ PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493918420400

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention