BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS PREMIER?

    MDR report key: 4151249 · Received October 8, 2014

    Report

    Report Number
    2134265-2014-06080
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    September 10, 2014
    Report Date
    September 11, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4). DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. 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 DIFFICULTY REMOVING THE BALLOON FROM THE STENT OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED UNSPECIFIED TARGET VESSEL. A 38 X 2.50 PROMUS PREMIER¿ DRUG ELUTING STENT WAS SELECTED FOR USE TO TREAT THE LESION. HOWEVER, AFTER STENT DEPLOYMENT, THE PHYSICIAN ENCOUNTERED DIFFICULTY REMOVING THE BALLOON FROM THE IMPLANTED STENT. IT WAS NOTED THE BALLOON DID NOT REWRAP WELL. THE PHYSICIAN MANAGED TO REMOVE THE BALLOON SLOWLY AND INTACT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633092 PROMUS PREMIER? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493925138250

    Patients

    Seq Age Sex Outcome Treatment
    1