BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT? PLUS

    MDR report key: 3220878 · Received July 11, 2013

    Report

    Report Number
    2134265-2013-04733
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Report Date
    June 13, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE CATHETER WAS RETURNED IN TWO SECTIONS. THE HYPOTUBE WAS BROKEN AT 210 MM FROM THE MANIFOLD STRAIN RELIEF. THE HYPOTUBE WAS ALSO SEVERELY KINKED JUST DISTAL AND PROXIMAL TO LOCATION OF THE BREAK. THE HYPOTUBE COATING HAD A SCRATCH OF 2 MM APPROXIMATELY 6 MM DISTAL TO THE BREAK POINT. NO ISSUES WERE NOTED WITH THE CRIMPED STENT, TIP AND BALLOON OF THE DEVICE THAT COULD HAVE POTENTIALLY CONTRIBUTED TO THE COMPLAINT INCIDENT. THE BALLOON WAS TIGHTLY WRAPPED AND WAS NOT SUBJECTED TO POSITIVE PRESSURE. TRACES OF BLOOD WERE VISIBLE IN THE GUIDEWIRE LUMEN INDICATING THE DEVICE WAS USED IN VIVO. 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, SHAFT BREAK AND CATHETER REMOVAL DIFFICULTY OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN A DIAGONAL BIFURCATION IN THE MODERATELY CALCIFIED AND MODERATE TO SEVERELY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY. A 2.50 X 20 MM PROMUS ELEMENT¿ PLUS STENT WAS USED TO TREAT THE TARGET LESION. LOTS OF RESISTANCE WERE ENCOUNTERED AS THE STENT WAS BEING PULLED OUT FROM THE NON BSC GUIDE CATHETER, SO THE SHAFT OF THE STENT DELIVERY SYSTEM SNAPPED. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, SHAFT BREAK AND CATHETER REMOVAL DIFFICULTY OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN A DIAGONAL BIFURCATION IN THE MODERATELY CALCIFIED AND MODERATE TO SEVERELY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY. A 2.50 X 20 MM PROMUS ELEMENT PLUS STENT WAS USED TO TREAT THE TARGET LESION. LOTS OF RESISTANCE WERE ENCOUNTERED AS THE STENT WAS BEING PULLED OUT FROM THE NON BSC GUIDE CATHETER, SO THE SHAFT OF THE STENT DELIVERY SYSTEM SNAPPED. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321141 PROMUS ELEMENT? PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911420250 15976998

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE CATHETER (MEDTRONIC)