BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS PREMIER?

    MDR report key: 4963169 · Received August 4, 2015

    Report

    Report Number
    2134265-2015-04991
    Event Type
    Injury
    Date Received
    August 4, 2015
    Date of Event
    July 5, 2015
    Report Date
    July 8, 2015
    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 IS A COMBINATION PRODUCT. (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 INADEQUATE APPOSITION AND STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED ON A SAPHENOUS VEIN GRAFT (SVG) IN THE VERY CALCIFIED RIGHT CORONARY ARTERY (RCA). A 4.00X20MM PROMUS PREMIER¿ DRUG ELUTING STENT WAS IMPLANTED TO TREAT THE LESION. HOWEVER, POST DEPLOYMENT, THE PHYSICIAN NOTED THAT THE STENT LOOKED A LITTLE ABNORMAL AND WASN'T INFLATED ALL THE WAY. SUBSEQUENTLY, THE PHYSICIAN ADVANCED A NON-BSC IVUS CATHETER. ON THE WAY BACK OUT, THE CATHETER HIT THE BACK END OF THE STENT AND CAUSED STENT DEFORMATION. ANOTHER STENT OF THE SAME MODEL WAS IMPLANTED DISTAL TO THE STENT. THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    508969 PROMUS PREMIER? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493952820400 17953602

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention