BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT ¿

    MDR report key: 2232897 · Received September 2, 2011

    Report

    Report Number
    2134265-2011-03729
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 11, 2011
    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

    (B)(4).

    Additional Manufacturer Narrative · 1

    A VISUAL AND MICROSCOPIC EXAMINATION FOUND NO ISSUES WITH THE DEVICE. NO KINKS OR DAMAGE WERE NOTICED ALONG THE SHAFT OF THE DEVICE. THE BALLOON, STENT 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 CLASSIFICATION OF THIS INVESTIGATION IS NOT CONFIRMED. THE COMPLAINT INCLUDED A RETURNED DEVICE REVIEW WHICH SHOWED NO EVIDENCE OF EITHER THE ALLEGED ISSUE OR ANY DEFECT WHICH COULD HAVE CONTRIBUTED TO THE EVENT. THE COMPLAINT REPORT STATED THAT THE STENT OF THIS DEVICE MOVED ON THE BALLOON. THE DEVICE WAS ANALYSED AND NO DAMAGE WAS EVIDENT ON THE DEVICE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A STENTING TREATMENT PROCEDURE, THE STENT MOVED ON THE BALLOON. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. UPON UNPACKING THE 2.50X16MM PROMUS ELEMENT STENT, THE PHYSICIAN NOTED THAT THE STENT WASN'T PLACED PROPERLY ON THE BALLOON. THE DEVICE WAS NOT USED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE. THIS PRODUCT IS ONLY OUS APPROVED, BUT IT IS SIMILAR TO AN APPROVED US DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A STENTING TREATMENT PROCEDURE, THE STENT MOVED ON THE BALLOON. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. UPON UNPACKING THE 2.50X16MM PROMUS ELEMENT STENT, THE PHYSICIAN NOTED THAT THE STENT WASN'T PLACED PROPERLY ON THE BALLOON. THE DEVICE WAS NOT USED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE. THIS PRODUCT IS ONLY OUS APPROVED BUT IT IS SIMILAR TO AN APPROVED US DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS ELEMENT ¿ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911316250 13953219

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR