BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT

    MDR report key: 8718461 · Received June 20, 2019

    Report

    Report Number
    2134265-2019-07224
    Event Type
    Malfunction
    Date Received
    June 20, 2019
    Date of Event
    November 30, 2018
    Report Date
    June 20, 2019
    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

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER.PROMUS ELEMENT MR OUS 3.00 X 20 MM STENT DELIVERY SYSTEM WAS RETURNED FOR ANALYSIS. A VISUAL EXAMINATION OF THE STENT FOUND STENT DAMAGE. STENT STRUTS ON THE MID-SECTION STENT STRUT ROWS WERE NOTED TO BE LIFTED AND PULLED DISTALLY. STENT STRUTS ON THE FIRST DISTAL STENT STRUT ROW WERE NOTED TO BE LIFTED AND PULLED OVER IN A PROXIMAL DIRECTION. THE UNDAMAGED STENT OD (OUTER DIAMETER) WAS MEASURED AND THE RESULT WAS WITHIN MAXIMUM CRIMPED STENT PROFILE MEASUREMENT. THE BALLOON CONES WERE REVIEWED AND NO ISSUES WERE NOTED. THE BALLOON WINGS WERE TIGHTLY WRAPPED AND EVE NLY FOLDED AND WERE NOT SUBJECTED TO POSITIVE PRESSURE. A VISUAL AND MICROSCOPIC EXAMINATION OF THE BUMPER TIP SHOWED NO SIGNS OF DAMAGE. A VISUAL AND TACTILE EXAMINATION OF TBHE HYPOTUBE FOUND MULTIPLE KINKS ALONG SEVERAL LOCATIONS OF THE HYPOTUBE SHAFT. A VISUAL AND TACTILE EXAMINATION OF THE OUTER AND MID-SHAFT SECTION AND A VISUAL EXAMINATION OF THE INNER LUMEN FOUND NO ISSUES ALONG THE SHAFT POLYMER EXTRUSION.

    Description of Event or Problem · 1

    REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 28MAY2019. IT WAS REPORTED THAT THE DEVICE COULD NOT CROSS LESION. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. A PROMUS ELEMENT STENT BALLOON EXPANDABLE WAS SELECTED FOR USE BUT IT COULD NOT CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. PATIENT IS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED A STENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509603 PROMUS ELEMENT STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC CORPORATION 9307 0020835739

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR