BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS PREMIER?

    MDR report key: 4093460 · Received September 16, 2014

    Report

    Report Number
    2134265-2014-05493
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    June 20, 2014
    Report Date
    August 25, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE IS A COMBINATION PRODUCT. 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 7TH ROW FROM THE DISTAL 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 A KINK IN THE HYPOTUBE SHAFT 135MM PROXIMAL FROM THE STRAIN RELIEF. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE FORCE BEING APPLIED TO THE DELIVERY SYSTEM. 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).

    Description of Event or Problem · 1

    REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(4) 2014. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED.   THE TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND SEVERELY TORTUOUS UNSPECIFIED VESSEL. A 20 X 2.50 PROMUS PREMIER¿ DRUG ELUTING STENT WAS ADVANCED TO TREAT THE LESION, HOWEVER, THE DEVICE WAS UNABLE TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE.  NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD . HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571058 PROMUS PREMIER? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493925120250 16830361

    Patients

    Seq Age Sex Outcome Treatment
    1