BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS PREMIER?

    MDR report key: 4140133 · Received October 3, 2014

    Report

    Report Number
    2134265-2014-05926
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Report Date
    September 9, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE STENT DELIVERY SYSTEM (SDS) WAS RETURNED FOR ANALYSIS. A VISUAL EXAMINATION OF THE CRIMPED STENT FOUND STENT STRUTS ON THE 4TH AND 8TH ROWS FROM THE PROXIMAL END OF THE CRIMPED STENT WERE DISTORTED AND LIFTED UPWARDS FROM THE STENT PROFILE. THE BUMPER TIP OF THE DEVICE SHOWED NO SIGNS OF DAMAGE. THE BALLOON CONES PROFILES WERE REVIEWED AND NO ISSUES WERE NOTED WITH THE OVERALL BALLOON PROFILE. THE BALLOON WINGS WERE TIGHTLY WRAPPED AND EVENLY FOLDED AND WERE NOT SUBJECTED TO POSITIVE PRESSURE. A VISUAL AND TACTILE EXAMINATION FOUND NO ISSUES WITH THE HYPOTUBE PROFILE AND THE SHAFT POLYMER EXTRUSION PROFILE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STENT DAMAGED OCCURRED. THE TARGET LESION WAS LOCATED IN THE CALCIFIED LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 4.00X38MM PROMUS PREMIER¿ DRUG ELUTING STENT WAS ADVANCED TO TREAT THE TARGET LESION. HOWEVER, THE DEVICE WAS UNABLE TO CROSS THE LESION. THE PHYSICIAN THEN REMOVED THE DEVICE FROM THE PATIENT AND IT WAS NOTED THAT THE PROXIMAL EDGE OF THE STENT WAS DAMAGED. THE PROCEDURE WAS COMPLETED WITH A 4.0X38 NON BSC DRUG ELUTING STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS WAS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STENT DAMAGED OCCURRED. THE TARGET LESION WAS LOCATED IN THE CALCIFIED LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 4.00X38MM PROMUS PREMIER¿ DRUG ELUTING STENT WAS ADVANCED TO TREAT THE TARGET LESION. HOWEVER, THE DEVICE WAS UNABLE TO CROSS THE LESION. THE PHYSICIAN THEN REMOVED THE DEVICE FROM THE PATIENT AND IT WAS NOTED THAT THE PROXIMAL EDGE OF THE STENT WAS DAMAGED. THE PROCEDURE WAS COMPLETED WITH A 4.0X38 NON BSC DRUG ELUTING STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619881 PROMUS PREMIER? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493952838400 17064536

    Patients

    Seq Age Sex Outcome Treatment
    1