BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS PREMIER

    MDR report key: 10134627 · Received June 9, 2020

    Report

    Report Number
    2134265-2020-07760
    Event Type
    Malfunction
    Date Received
    June 9, 2020
    Date of Event
    June 4, 2020
    Report Date
    November 11, 2020
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (E1) INITIAL REPORTER FIRST NME: (B)(6). DEVICE EVALUATED BY MFR.: A PROMUS PREMIER OUS MR 38 X 2.75 STENT DELIVERY SYSTEM WAS RETURNED FOR ANALYSIS. A VISUAL EXAMINATION OF THE STENT FOUND STENT DAMAGE. STENT STRUTS LIFTED FROM CRIMPED POSITION AT TWO LOCATIONS IN THE MID-SECTION OF THE STENT. THE UNDAMAGED STENT OUTER DIAMETER WAS MEASURED AND THE RESULT WAS WITHIN MAXIMUM CRIMPED STENT PROFILE MEASUREMENT. THE BALLOON WAS 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 HYPOTUBE FOUND NO ISSUES. A VISUAL AND TACTILE EXAMINATION OF THE SHAFT POLYMER EXTRUSION FOUND NO ISSUES. AN EXAMINATION (VISUAL AND VIA SCOPE) FOUND DAMAGE. DEVICE TRACKED WITHOUT ISSUES ON A 0.0140" TEST GUIDEWIRE. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT STENT DAMAGE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT FEMORAL ARTERY. THE 90% STENOSED, 2.75MM X 32MM, CONCENTRIC, DE NOVO TARGET LESION CONTAINING A >45 DEGREES BEND WAS LOCATED IN THE SEVERELY TORTUOUS AND MILDLY CALCIFIED LEFT CIRCUMFLEX CORONARY ARTERY. AFTER ENGAGING THE LESION WITH AN EBU 3 GUIDE CATHETER AND CROSSED WITH A NON-BSC GUIDE WIRE, A 2X12 MAVERICK BALLOON CATHETER WAS USED TO PRE-DILATE THE LESION. A 38X2.75MM PROMUS PREMIER DRUG-ELUTING STENT WAS ADVANCED BUT HAD DIFFICULTY TRACKING AND THE PHYSICIAN FELT RESISTANCE. DURING REMOVAL, IT WAS FOUND THAT THE STENT STRUTS WERE DAMAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER STENT OF THE SAME SIZE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Additional Manufacturer Narrative · 1

    (B)(6). DEVICE IS A COMBINATION PRODUCT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STENT DAMAGE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT FEMORAL ARTERY. THE 90% STENOSED, 2.75MM X 32MM, CONCENTRIC, DE NOVO TARGET LESION CONTAINING A >45 DEGREES BEND WAS LOCATED IN THE SEVERELY TORTUOUS AND MILDLY CALCIFIED LEFT CIRCUMFLEX CORONARY ARTERY. AFTER ENGAGING THE LESION WITH AN EBU 3 GUIDE CATHETER AND CROSSED WITH A NON-BSC GUIDE WIRE, A 2 X 12 MAVERICK BALLOON CATHETER WAS USED TO PRE-DILATE THE LESION. A 38 X 2.75MM PROMUS PREMIER DRUG-ELUTING STENT WAS ADVANCED BUT HAD DIFFICULTY TRACKING AND THE PHYSICIAN FELT RESISTANCE. DURING REMOVAL, IT WAS FOUND THAT THE STENT STRUTS WERE DAMAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER STENT OF THE SAME SIZE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597854 PROMUS PREMIER STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC CORPORATION 9554 0022874525

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR