BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS PREMIER?

    MDR report key: 3950878 · Received July 22, 2014

    Report

    Report Number
    2134265-2014-04607
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    July 10, 2014
    Report Date
    July 14, 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

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER 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 NO ISSUES WITH THE PROFILE WITH NO SIGNS OF OVERLAPPING OR RAISED STENT STRUTS. 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 SHAFT PROFILE. A VISUAL AND TACTILE EXAMINATION FOUND NO ISSUES WITH THE 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. BSC ID # A00462975 / TW # 3306836

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A STENT DAMAGE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY CALCIFIED AND MODERATELY TORTUOUS PROXIMAL LEFT CIRCUMFLEX ARTERY (LCX). A 6F 3.0 NON BSC GUIDE CATHETER WAS USED. AFTER A NON BSC GUIDE WIRE CROSSED THE LESION, AN OPTICROSS IMAGING CATHETER WAS ADVANCED TO OBSERVE THE LESION. THEN THE 2MM0 X 3.00MM PROMUS PREMIER¿ STENT WAS ADVANCED BUT WAS UNABLE TO CROSS THE PROXIMAL LCX. THE DEVICE WAS REMOVED FROM THE PATIENT AND IT WAS FOUND OUT THAT THE DISTAL EDGE OF THE STENT WAS DAMAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT¿S STATUS IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A STENT DAMAGE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY CALCIFIED AND MODERATELY TORTUOUS PROXIMAL LEFT CIRCUMFLEX ARTERY (LCX). A 6F 3.0 NON BSC GUIDE CATHETER WAS USED. AFTER A NON BSC GUIDE WIRE CROSSED THE LESION, AN OPTICROSS IMAGING CATHETER WAS ADVANCED TO OBSERVE THE LESION. THEN THE 2MM0 X 3.00MM PROMUS PREMIER¿ STENT WAS ADVANCED BUT WAS UNABLE TO CROSS THE PROXIMAL LCX. THE DEVICE WAS REMOVED FROM THE PATIENT AND IT WAS FOUND OUT THAT THE DISTAL EDGE OF THE STENT WAS DAMAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428998 PROMUS PREMIER? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493925120300 16986221

    Patients

    Seq Age Sex Outcome Treatment
    1 IMAGING CATHETER: OPTICROSS| GUIDE CATHETER:6F HEARTRAIL JL3.0/TERUMO| INFLATION DEVICE:EVEREST| GUIDE WIRE:SION BLUE/ASAHI| BALLOON CATHETER:APEX 3.0X15