BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS PREMIER

    MDR report key: 8387976 · Received March 4, 2019

    Report

    Report Number
    2134265-2019-01937
    Event Type
    Malfunction
    Date Received
    March 4, 2019
    Date of Event
    December 27, 2018
    Report Date
    March 4, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFT: PROMUS PREMIER OUS MR 32 X 2.50 MM STENT DELIVERY SYSTEM WAS RETURNED FOR ANALYSIS. A VISUAL EXAMINATION OF THE STENT FOUND DAMAGE TO DISTAL STENT ROWS 14-18. THE UNDAMAGED CRIMPED STENT OUTER DIAMETER WAS WITHIN MAXIMUM CRIMPED STENT PROFILE MEASUREMENT. THE TIP WAS VISUALLY AND MICROSCOPICALLY EXAMINED AND DAMAGE WAS NOTED. 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 TACTILE EXAMINATION OF THE DEVICE FOUND MULTIPLE HYPOTUBE KINKS. A VISUAL AND TACTILE EXAMINATION OF THE INNER AND OUTER LUMEN AND MID-SHAFT SECTION FOUND NO ISSUES ALONG THE SHAFT POLYMER EXTRUSION. NO ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS.

    Description of Event or Problem · 1

    REPORTABLE BASED ON THE DEVICE ANALYSIS COMPLETED ON 11FEB2019. IT WAS REPORTED THAT SHAFT KINK OCCURRED. VASCULAR ACCESS HAS OBTAINED VIA THE FEMORAL ARTERY. THE CONCENTRIC TARGET LESION WITH A BEND OF GREATER THAN OR EQUAL TO 90 DEGREES WAS LOCATED IN THE MILDLY CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. A 32 X 2.50MM PROMUS PREMIER DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING MANIPULATION, IT WAS NOTED THAT THE SHAFT WAS ACUTELY KINKED. THE PROCEDURE WAS COMPLETED USING WITH A DIFFERENT DEVICE AIDED BY A GUIDEZILLA GUIDE EXTENSION CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED DISTAL STENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179873 PROMUS PREMIER STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC CORPORATION 9553 0020859679

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR