BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS PREMIER

    MDR report key: 11310586 · Received February 10, 2021

    Report

    Report Number
    2134265-2021-01563
    Event Type
    Malfunction
    Date Received
    February 10, 2021
    Date of Event
    December 11, 2020
    Report Date
    February 10, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MF.: A PROMUS PREMIER OUS MR 24 X 2.75 MM STENT DELIVERY SYSTEM WAS RETURNED FOR ANALYSIS. A VISUAL EXAMINATION OF THE STENT FOUND THAT STENT STRUTS IN THE MOST DISTAL STENT STRUT ROW WERE LIFTED FROM THE CRIMPED STENT POSITION. THE UNDAMAGED CRIMPED STENT OUTER DIAMETER WAS MEASURED AND THE RESULT WAS WITHIN MAXIMUM CRIMPED STENT PROFILE MEASUREMENT. STENT DAMAGE MOST LIKELY OCCURRED WHEN THE STRUTS WERE CAUGHT IN CALCIFICATION DURING WITHDRAWAL ATTEMPTS. THE BALLOON CONES WERE REVIEWED, AND NO ISSUES WERE NOTED. THE BALLOON WINGS WERE TIGHTLY WRAPPED AND EVENLY FOLDED AND WERE NOT SUBJECTED TO POSITIVE PRESSURE. A VISUAL AND MICROSCOPIC EXAMINATION OF THE TIP SHOWED NO SIGNS OF DAMAGE. A VISUAL AND TACTILE EXAMINATION OF THE HYPOTUBE FOUND NO ISSUES WITH THE HYPOTUBE SHAFT. A VISUAL AND TACTILE EXAMINATION OF THE OUTER AND MID-SHAFT SECTION AND A VISUAL EXAMINATION OF THE INNER EXTRUSION FOUND NO ISSUES ALONG THE SHAFT POLYMER EXTRUSION. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS.

    Description of Event or Problem · 1

    REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 21-JAN 2021. IT WAS REPORTED THAT CROSSING DIFFICULTY WAS ENCOUNTERED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED RIGHT CORONARY ARTERY. A 24 X 2.75 PROMUS PREMIER DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT BUT COULD NOT CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    207792 PROMUS PREMIER STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC CORPORATION 9551 0024068158

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR