BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS PREMIER?

    MDR report key: 3951419 · Received July 22, 2014

    Report

    Report Number
    2134265-2014-04244
    Event Type
    Injury
    Date Received
    July 22, 2014
    Date of Event
    June 25, 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 Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE IS COMBINATION PRODUCT. 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 DISLODGEMENT OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED DISTAL OF LEFT CIRCUMFLEX (LCX) ARTERY. AN UNSPECIFIED GUIDE WIRE AND AN IVUS CATHETER WERE ADVANCED TO THE LESION. A 1.2MM UNSPECIFIED SEMI COMPLIANCE BALLOON CATHETER WAS UNABLE TO CROSS THE LESION. THE PHYSICIAN ATTEMPTED TO CROSS A 2.25X15 NON-BSC STENT; HOWEVER, THE NON-BSC STENT WAS UNABLE TO CROSS THE LESION AND THE SHAFT WAS KINKED. A 2.25X12 UNSPECIFIED STENT WAS ADVANCED; HOWEVER THE DEVICE WAS STILL UNABLE TO CROSS THE LESION. WHEN THE 2.25X12 UNSPECIFIED STENT WAS REMOVED, IT WAS NOTED THE EDGE OF THE STENT WAS LIFTED. A 16 X 2.25 PROMUS PREMIER¿ STENT DELIVERY SYSTEM (SDS) WAS SELECTED TO TREAT THE LESION; HOWEVER THIS DEVICE WAS UNABLE TO CROSS THE TARGET LESION. WHEN THE SDS WAS REMOVED, IT WAS NOTED THAT THE STENT DISLODGED AT THE PROXIMAL END OF THE LCX AND REMAINED ON THE GUIDE WIRE. AN UNSPECIFIED BALLOON CATHETER WAS USED TO ADVANCE THE DISLODGED STENT INTO THE LESION. THE STENT WAS SUCCESSFULLY DEPLOYED. THE PHYSICIAN SUSPECTED THAT THE CALCIFICATION OF THE LESION CAUSED THE EVENT. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428468 PROMUS PREMIER? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493925116220 16844823

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention