BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT ¿

    MDR report key: 2822885 · Received November 7, 2012

    Report

    Report Number
    2134265-2012-06738
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Date of Event
    October 9, 2012
    Report Date
    October 10, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS RETURNED FOR ANALYSIS. A VISUAL AND MICROSCOPIC EXAMINATION IDENTIFIED KINKS ALONG THE ENTIRE LENGTH OF THE HYPOTUBE. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE FORCE BEING APPLIED TO THE DELIVERY SYSTEM. THE CRIMPED STENT, 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. 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). AGE AT THE TIME OF EVENT: 18 YEARS OR OLDER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS DISTAL LEFT CIRCUMFLEX (LCX) ARTERY. THE PHYSICIAN ATTEMPTED TO CROSS THE DISTAL LCX USING A 3.0X20MM PROMUS ELEMENT MR STENT DELIVERY SYSTEM (SDS) BUT THE DEVICE WAS UNABLE TO CROSS THE LESION. THE DEVICE WAS REMOVED FROM THE PATIENT AND IT WAS NOTED THAT THE STENT GOT FLARED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION WAS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS DISTAL LEFT CIRCUMFLEX (LCX) ARTERY. THE PHYSICIAN ATTEMPTED TO CROSS THE DISTAL LCX USING A 3.0 X 20 MM PROMUS ELEMENT MR STENT DELIVERY SYSTEM (SDS), BUT THE DEVICE WAS UNABLE TO CROSS THE LESION. THE DEVICE WAS REMOVED FROM THE PATIENT AND IT WAS NOTED THAT THE STENT GOT FLARED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS ELEMENT ¿ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911320300 14962804

    Patients

    Seq Age Sex Outcome Treatment
    1