BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS PREMIER?

    MDR report key: 3953045 · Received July 23, 2014

    Report

    Report Number
    2134265-2014-04267
    Event Type
    Injury
    Date Received
    July 23, 2014
    Date of Event
    June 26, 2014
    Report Date
    June 26, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (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 STENT DAMAGE AND DISLODGEMENT OCCURRED.THE 95% STENOSED AND HEAVILY CALCIFIED TARGET LESION WAS LOCATED IN THE DISTAL LEFT MAIN (LM) AND OSTIAL LEFT CIRCUMFLEX (LCX) ARTERY. ROTABLATION OF THE DISTAL LM AND OSTIAL LEFT ANTERIOR DESCENDING (LAD) ARTERY WERE PERFORMED WITH SUBSEQUENT PLACEMENT OF A 4.0X16MM PROMUS PREMIER STENT IN THE DISTAL LM AND PROXIMAL LAD ARTERY. THE LESION WAS PRE-DILATED WITH SEVERAL APEX AND NC QUANTUM APEX BALLOONS. THE PHYSICIAN THEN USED A GUIDE WIRE TO CROSS THROUGH THAT STENT'S SIDE CELLS, IN THE MID STENT AND INTO THE LCX.THE SIDE CELL WAS PRE-DILATED WITH A BALLOON, BUT THE 3.50X12MM PROMUS PREMIER WAS NOT ABLE TO CROSS. UPON REMOVAL, THE STENT HAD DISLODGED AND WAS DISCOVERED IN THE HUB AREA OF THE GUIDE WITH DAMAGE NOTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE DEPLOYED IN THE PROXIMAL LCX. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431060 PROMUS PREMIER? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493952812350 16763726

    Patients

    Seq Age Sex Outcome Treatment
    1