BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT ¿ LONG

    MDR report key: 2943754 · Received February 5, 2013

    Report

    Report Number
    2134265-2013-00541
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 9, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: INITIAL VISUAL EXAMINATION OF THE RETURNED DEVICE NOTED THAT THE MID SECTION OF THE STENT APPEARED STRETCHED. THE PROFILE OF THE STENT ALSO WAS SLIGHTLY KINKED. MICROSCOPIC EXAMINATION OF THE BALLOON PROFILE FOUND NO EVIDENCE OF DAMAGE PRESENT. NO FURTHER DAMAGE WAS NOTED WITH THE RETURNED DEVICE WHICH COULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. 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 TRANSLUMINAL CORONARY ANGIOPLASTY TREATMENT PROCEDURE STENT DAMAGE OCCURRED. THE LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. THE PROMUS ELEMENT,MR,OUS 3.00X38MM STENT WAS UNABLE TO CROSS THE LESION EVEN AFTER MULTIPLE DILATATIONS. THE DEVICE WAS REMOVED AND IT WAS NOTED THAT A FEW STRUTS ON THE MID PORTION OF THE STENT WERE DISMANTLED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY TREATMENT PROCEDURE STENT DAMAGE OCCURRED. THE LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. THE PROMUS ELEMENT,MR,OUS 3.00X38MM STENT WAS UNABLE TO CROSS THE LESION EVEN AFTER MULTIPLE DILATATIONS. THE DEVICE WAS REMOVED AND IT WAS NOTED THAT A FEW STRUTS ON THE MID PORTION OF THE STENT WERE DISMANTLED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48620 PROMUS ELEMENT ¿ LONG STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911338300 0015571090

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR