BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS PREMIER?

    MDR report key: 3770695 · Received April 24, 2014

    Report

    Report Number
    2134265-2014-02183
    Event Type
    Injury
    Date Received
    April 24, 2014
    Date of Event
    March 27, 2014
    Report Date
    March 30, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 REMOVAL DIFFICULTY, STENT DISLODGEMENT AND STENT DAMAGE OCCURRED. THE 16MM IN LENGTH, DE NOVO TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED, 2.5MM IN DIAMETER OSTIUM OF THE LEFT CIRCUMFLEX ARTERY. AN UNSPECIFIED GUIDE CATHETER WAS USED. THEN A 3.0MM NON BSC BALLOON CATHETER WAS ADVANCED FOR PREDILATION AT AN UNSPECIFIED HIGH PRESSURES. THEN THE 2.5MM X 16 PROMUS PREMIER STENT WAS ADVANCED ACROSS THE LEFT MAIN ARTERY TO THE TARGET LESION WITHOUT DIFFICULTIES. ANOTHER 2.5MM X 12MM PROMUS PREMIER STENT WAS ADVANCED THROUGH THE GUIDE CATHETER TO THE RAMUS ARTERY BUT ENCOUNTERED DIFFICULTY SO THE STENT WAS REMOVED. THE PHYSICIAN WANTED TO REMOVE THE 2.5MM X 16 PROMUS PREMIER STENT SINCE HE HAD DIFFICULTY DELIVERING ANOTHER STENT THROUGH THE GUIDE CATHETER AND HE WANTED TO SWITCH THIS GUIDE CATHETER TO ANOTHER. THE 2.5MM X 16 PROMUS PREMIER STENT WAS NOT ABLE TO BE REMOVED AND THE STENT WAS DISLODGED FROM THE DELIVERY SYSTEM BALLOON. THE PHYSICIAN SUSPECTED THAT THERE MAY BE A FLARE ON THE DISTAL PART OF THE STENT. THE DETACHED STENT WAS COVERED WITH ANOTHER UNSPECIFIED STENT AGAINST THE VESSEL WALL AND THE PROCEDURE WAS COMPLETED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249392 PROMUS PREMIER? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY UNK758

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention BALLOON CATHETER: 3.0MM ANGIOSCULPT