BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS PREMIER

    MDR report key: 19412537 · Received May 29, 2024

    Report

    Report Number
    2124215-2024-32222
    Event Type
    Malfunction
    Date Received
    May 29, 2024
    Date of Event
    April 17, 2024
    Report Date
    July 24, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATED BY MFR.: A PROMUS PREMIER OUS MR 28 X 3.50MM, WAS RETURNED FOR ANALYSIS. A VISUAL AND TACTILE EXAMINATION IDENTIFIED MULTIPLE KINKS ALONG THE HYPOTUBE. A VISUAL AND TACTILE EXAMINATION OF THE DISTAL EXTRUSION IDENTIFIED NO DAMAGES. A MICROSCOPIC EXAMINATION OF THE DISTAL EXTRUSION IDENTIFIED NO DAMAGES. A MICROSCOPIC EXAMINATION OF THE BALLOON MATERIAL IDENTIFIED NO DAMAGES. THE BALLOON WAS TIGHTLY FOLDED. A MICROSCOPIC EXAMINATION OF THE CRIMPED STENT IDENTIFIED NO DAMAGES. THE STENT WAS SECURELY CRIMPED BETWEEN THE PROXIMAL AND DISTAL MARKERBANDS. A MICROSCOPIC EXAMINATION OF THE TIP IDENTIFIED NO DAMAGES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 85% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY, WITH A LENGTH OF 28 MM AND A VESSEL DIAMETER OF 3.5 MM. A 28 X 3.50 PROMUS PREMIER DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, THE SHAFT OF THE STENT FRACTURED AND COULD NOT BE USED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT CONDITION WAS STABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 85% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY, WITH A LENGTH OF 28 MM AND A VESSEL DIAMETER OF 3.5 MM. A 28 X 3.50 PROMUS PREMIER DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, THE SHAFT OF THE STENT FRACTURED AND COULD NOT BE USED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT CONDITION WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1824852 PROMUS PREMIER STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC CORPORATION 9552 0032954921

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male