BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT ¿

    MDR report key: 2923186 · Received January 18, 2013

    Report

    Report Number
    2134265-2013-00176
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Date of Event
    October 5, 2012
    Report Date
    January 3, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: VISUAL EXAMINATION OF THE RETURNED DEVICE IDENTIFIED THE STRUTS OF THE MOST DISTAL STENT ROW WERE SLIGHTLY FLARED AND SEVERAL STRUTS FROM THE MOST PROXIMAL STENT ROW WERE BENT BACK DISTALLY. THIS TYPE OF DAMAGE IS CONSISTENT WITH SOME FORM OF RESTRICTION HAVING OCCURRED. THE BALLOON WAS TIGHTLY WRAPPED AND WAS NOT SUBJECTED TO POSITIVE PRESSURE. FURTHER EXAMINATION FOUND THAT THE HYPOTUBE WAS KINKED AT 185 MM DISTAL TO THE DISTAL END OF THE STRAIN RELIEF. NO OTHER ISSUES WERE NOTED WITH THE DEVICE. 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) 2013. IT WAS REPORTED THAT DURING A CORONARY ARTERY STENTING TREATMENT PROCEDURE, FAILURE TO CROSS THE LESION OCCURRED. THE 84% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD). THE LESION WAS PRE-DILATED WITH A 2.0X15MM MAVERICK BALLOON CATHETER. A 3.00X20MM PROMUS ELEMENT WAS SELECTED AND ADVANCED TO TREAT THE TARGET LESION; HOWEVER, THE DEVICE WAS UNABLE TO CROSS THE LESION. THE DEVICE WAS REMOVED INTACT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS STABLE. HOWEVER, THE RETURNED DEVICE REVEALED STENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27394 PROMUS ELEMENT ¿ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911320300 15213236

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR