BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT? PLUS

    MDR report key: 3122418 · Received May 21, 2013

    Report

    Report Number
    2134265-2013-03255
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    April 22, 2013
    Report Date
    April 22, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER - THE ACTUAL DELIVERY DEVICE WAS NOT RETURNED, ONLY THE STENT WAS RETURNED. THE STENT WAS SEVERELY STRETCHED ALONG ITS LENGTH CAUSING SOME STENT STRUTS TO BE RAISED UP. 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 DURING A STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. VASCULAR ACCESS WAS GAINED VIA THE RIGHT FEMORAL ARTERY. THE MILDLY TORTUOUS AND NON-CALCIFIED PROGRESSIVE TARGET LESION WAS LOCATED IN THE 3.0X26MM, 90% STENOSED POSTERIOR DESCENDING ARTERY (PDA) AND 2.5X10MM, 80% STENOSED 1ST DIAGONAL (D1) ARTERY BIFURCATION, WITH AN EJECTION FRACTION ON 50% AND SIGNIFICANT BEND BETWEEN 45 AND 90 DEGREES. THE PDA WAS PRE-DILATED WITH A 2.5X15MM MAVERICK BALLOON. A 3.0X28MM PROMUS ELEMENT PLUS STENT WAS SUCCESSFULLY DEPLOYED IN THE PDA, RESULTING IN 0% RESIDUAL STENOSIS. THE PDA AND D1 WERE WIRED AND TWO 2.5X15MM BALLOONS WERE INFLATED AT 6 ATM SIMULTANEOUSLY, RESULTING IN 50% RESIDUAL STENOSIS. THE 2.5X12MM PROMUS ELEMENT PLUS STENT WAS ADVANCED TO THE D1 ARTERY HOWEVER WAS UNABLE TO CROSS THE LESION, UPON REMOVAL IT WAS NOTED THAT THE STENT WAS DAMAGED. THE PROCEDURE WAS COMPLETED WITH A 2.25X12MM PROMUS ELEMENT STENT DEPLOYED IN THE D1 ARTERY USING A CRUSH TECHNIQUE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS STABLE. DURING AN ATTEMPT TO CLEAN THE DEVICE TO BE SENT FOR DEVICE ANALYSIS THE STENT WAS DISLODGED FROM THE BALLOON.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. VASCULAR ACCESS WAS GAINED VIA THE RIGHT FEMORAL ARTERY. THE MILDLY TORTUOUS AND NON-CALCIFIED PROGRESSIVE TARGET LESION WAS LOCATED IN THE 3.0X26MM, 90% STENOSED POSTERIOR DESCENDING ARTERY (PDA) AND 2.5X10MM, 80% STENOSED 1ST DIAGONAL (D1) ARTERY BIFURCATION, WITH AN EJECTION FRACTION ON 50% AND SIGNIFICANT BEND BETWEEN 45 AND 90 DEGREES. THE PDA WAS PRE-DILATED WITH A 2.5X15MM MAVERICK BALLOON. A 3.0X28MM PROMUS ELEMENT PLUS STENT WAS SUCCESSFULLY DEPLOYED IN THE PDA, RESULTING IN 0% RESIDUAL STENOSIS. THE PDA AND D1 WERE WIRED AND TWO 2.5X15MM BALLOONS WERE INFLATED AT 6 ATM SIMULTANEOUSLY, RESULTING IN 50% RESIDUAL STENOSIS. THE 2.5X12MM PROMUS ELEMENT PLUS STENT WAS ADVANCED TO THE D1 ARTERY HOWEVER WAS UNABLE TO CROSS THE LESION, UPON REMOVAL IT WAS NOTED THAT THE STENT WAS DAMAGED. THE PROCEDURE WAS COMPLETED WITH A 2.25X12MM PROMUS ELEMENT STENT DEPLOYED IN THE D1 ARTERY USING A CRUSH TECHNIQUE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS STABLE. DURING AN ATTEMPT TO CLEAN THE DEVICE TO BE SENT FOR DEVICE ANALYSIS THE STENT WAS DISLODGED FROM THE BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224523 PROMUS ELEMENT? PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493918412250 15907479

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR GUIDE CATHETER: MACH 1 FL 3.5 6FR| BALLOON CATHETER: MAVERICK 2.5X15MM| GUIDEWIRE: .014 CHOICE FLOPPY