BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT? PLUS

    MDR report key: 3150217 · Received June 6, 2013

    Report

    Report Number
    2134265-2013-03623
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 15, 2013
    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

    DEVICE EVALUATED BY MFR: A VISUAL AND MICROSCOPIC EXAMINATION FOUND THAT THE HYPOTUBE WAS SLIGHTLY KINKED ALONG ITS LENGTH. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE FORCE BEING APPLIED TO THE DELIVERY SYSTEM. A VISUAL AND MICROSCOPIC EXAMINATION OF THE CRIMPED STENT FOUND NO ISSUES. THE BALLOON AND TIP SECTIONS OF THE DEVICE WERE VISUALLY AND MICROSCOPICALLY EXAMINED AND NO ISSUES WERE NOTED WITH THEIR PROFILES THAT COULD HAVE POTENTIALLY CONTRIBUTED TO THE COMPLAINT INCIDENT. THE BALLOON WAS TIGHTLY WRAPPED AND WAS NOT SUBJECTED TO POSITIVE PRESSURE. CONTRAST MEDIA WAS PRESENT WITHIN THE ENTIRE LENGTH OF THE LUMEN, THEREFORE INDICATING THAT THE DEVICE WAS PREPPED FOR USE. 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

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE IS A COMBINATION PRODUCT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. THE 90% STENOSED LESION WAS LOCATED IN THE CALCIFIED AND MODERATELY TORTUOUS POSTERIOR DESCENDING ARTERY OF THE RIGHT CORONARY ARTERY (RCA). A 2.25 MM X 12 MM PROMUS ELEMENT PLUS STENT WAS ADVANCED AND FAILED TO CROSS THE LESION. THE DEVICE WAS REMOVED AND NOTED THAT THE STENT WAS DAMAGED. THE PHYSICIAN PERFORMED THE PRE-DILATATION AGAIN. A 2.25 MM X 20 MM PROMUS ELEMENT STENT COMPLETED THE PROCEDURE AND WAS IMPLANTED. NO COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. THE 90% STENOSED LESION WAS LOCATED IN THE CALCIFIED AND MODERATELY TORTUOUS POSTERIOR DESCENDING ARTERY OF THE RIGHT CORONARY ARTERY (RCA). A 2.25 MM X 12 MM PROMUS ELEMENT PLUS STENT WAS ADVANCED AND FAILED TO CROSS THE LESION. THE DEVICE WAS REMOVED AND NOTED THAT THE STENT WAS DAMAGED. THE PHYSICIAN PERFORMED THE PRE-DILATATION AGAIN. A 2.25 MM X 20 MM PROMUS ELEMENT STENT COMPLETED THE PROCEDURE AND WAS IMPLANTED. NO COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250410 PROMUS ELEMENT? PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493918412220 15664257

    Patients

    Seq Age Sex Outcome Treatment
    1