BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT ¿

    MDR report key: 2770029 · Received October 3, 2012

    Report

    Report Number
    2134265-2012-05925
    Event Type
    Malfunction
    Date Received
    October 3, 2012
    Date of Event
    September 4, 2012
    Report Date
    September 5, 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 IS COMBINATION PRODUCT. AGE AT TIME OF EVENT 18 YEARS OR OLDER. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER A VISUAL AND MICROSCOPIC EXAMINATION IDENTIFIED A NUMBER OF PROXIMAL STENT STRUTS WERE BENT BACK DISTALLY AND A NUMBER OF OTHERS WERE SPLAYED OUTWARDLY. THIS TYPE OF DAMAGE IS CONSISTENT WITH THE STENT MEETING RESISTANCE UPON ADVANCEMENT AND/OR WITHDRAWAL. THE BALLOON WAS FOUND TO HAVE THE STENT IMPRESSIONS ON IT AND PILLOWING OF THE BALLOON INDICATING THAT THE STENT WAS CRIMPED PER PROCESS IN THE CORRECT LOCATION DURING MANUFACTURING. THE BALLOON OF THE DEVICE WAS VISUALLY AND MICROSCOPICALLY EXAMINED AND NO ISSUES WERE NOTED WITH THEIR PROFILES. THE BALLOON WAS TIGHTLY WRAPPED AND WAS NOT SUBJECTED TO ANY POSITIVE PRESSURE. NO KINKS OR DAMAGE WERE NOTICED ALONG THE SHAFT OF THE DEVICE. 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

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, STENT DAMAGE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN A CALCIFIED AND MODERATELY TORTUOUS MIDDLE LEFT ANTERIOR DESCENDING ARTERY. A PROMUS ELEMENT, MR 3.00 X 16MM STENT FAILED TO CROSS THE TARGET LESION. THE PROMUS ELEMENT STENT WAS REMOVED FROM THE PATIENT AND IT WAS NOTED THAT THE TIP OF THE STENT WAS LIFTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, STENT DAMAGE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN A CALCIFIED AND MODERATELY TORTUOUS MIDDLE LEFT ANTERIOR DESCENDING ARTERY. A PROMUS ELEMENT, MR 3.00 X 16MM STENT FAILED TO CROSS THE TARGET LESION. THE PROMUS ELEMENT STENT WAS REMOVED FROM THE PATIENT AND IT WAS NOTED THAT THE TIP OF THE STENT WAS LIFTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS ELEMENT ¿ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911316300 0015003302

    Patients

    Seq Age Sex Outcome Treatment
    1