BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS PREMIER?

    MDR report key: 4122561 · Received September 26, 2014

    Report

    Report Number
    2134265-2014-05739
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Report Date
    September 3, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE STENT DELIVERY SYSTEM WAS RETURNED FOR ANALYSIS. A VISUAL EXAMINATION OF THE CRIMPED STENT FOUND STENT STRUTS ON THE PROXIMAL PORTION OF THE CRIMPED STENT WERE DEFORMED AND LIFTED UPWARDS FROM THE STENT PROFILE. IT IS LIKELY THE CRIMPED STENT MAY HAVE ENCOUNTERED RESISTANCE & SUBSEQUENT DAMAGE DURING ADVANCEMENT ATTEMPTS. 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 MULTIPLE KINKS ALONG THE HYPOTUBE SHAFT. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE FORCE BEING APPLIED TO THE DELIVERY SYSTEM. A VISUAL AND TACTILE EXAMINATION FOUND NO ISSUES WITH THE PROFILE. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS. 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

    IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 12 X 3.00 PROMUS PREMIER¿ DRUG ELUTING STENT WAS SELECTED TO TREAT THE LESION. DURING INTRODUCTION OF THE DEVICE, THE PHYSICIAN FELT SOME RESISTANCE AND IMMEDIATELY REMOVED IT. THE PHYSICIAN NOTICED THAT THE MESH EXCEEDED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 12 X 3.00 PROMUS PREMIER¿ DRUG ELUTING STENT WAS SELECTED TO TREAT THE LESION. DURING INTRODUCTION OF THE DEVICE, THE PHYSICIAN FELT SOME RESISTANCE AND IMMEDIATELY REMOVED IT. THE PHYSICIAN NOTICED THAT THE MESH EXCEEDED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600461 PROMUS PREMIER? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493925112300 16842968

    Patients

    Seq Age Sex Outcome Treatment
    1