BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT¿ PLUS

    MDR report key: 2901071 · Received January 8, 2013

    Report

    Report Number
    2134265-2012-08349
    Event Type
    Malfunction
    Date Received
    January 8, 2013
    Date of Event
    December 13, 2012
    Report Date
    December 13, 2012
    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 MANUFACTURER: 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. NO KINKS OR DAMAGE WERE NOTICED ALONG THE SHAFT OF 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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A PERCUTANEOUS CORONARY INTERVENTION STENT DAMAGE WAS NOTED. THE 90% STENOSED AND MODERATELY TORTUOUS TARGET LESION WAS LOCATED IN THE DISTAL RIGHT CORONARY ARTERY. DURING UNPACKING IT WAS NOTED THAT THE 3.5X32MM PROMUS ELEMENT PLUS STENT WAS DAMAGED. THE STENT WAS USED DURING THE PROCEDURE AND WAS UNABLE TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT CONDITION IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A PERCUTANEOUS CORONARY INTERVENTION STENT DAMAGE WAS NOTED. THE 90% STENOSED AND MODERATELY TORTUOUS TARGET LESION WAS LOCATED IN THE DISTAL RIGHT CORONARY ARTERY. DURING UNPACKING IT WAS NOTED THAT THE 3.5X32MM PROMUS ELEMENT PLUS STENT WAS DAMAGED. THE STENT WAS USED DURING THE PROCEDURE AND WAS UNABLE TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT CONDITION IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9647 PROMUS ELEMENT¿ PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493918432350 15255974

    Patients

    Seq Age Sex Outcome Treatment
    1