BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT? PLUS

    MDR report key: 3042679 · Received April 9, 2013

    Report

    Report Number
    2134265-2013-02036
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Report Date
    March 11, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: A VISUAL AND MICROSCOPIC EXAMINATION IDENTIFIED A MIDSHAFT BREAK LOCATED 24.5CM FROM THE TIP. THE DEVICE WAS RETURNED IN TWO PIECES. A VISUAL AND MICROSCOPIC EXAMINATION ALSO IDENTIFIED DAMAGE TO THE INNER LUMEN. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE FORCE BEING APPLIED TO THE DELIVERY SYSTEM. THE 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 CONSIDERED HANDLING DAMAGE AS THE EVENT OCCURRED PRIOR TO PATIENT CONTACT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE SHAFT BREAK OCCURRED. A 2.25X12MM PROMUS ELEMENT PLUS STENT WAS SELECTED AND FLUSHED WHILE AN UNKNOWN WIRE WAS WIPED DOWN BEFORE USE. AS THEY WERE ADVANCING THE PROMUS ELEMENT PLUS,MR,US 2.25X12MM ON THE UNKNOWN WIRE IT BECAME VERY "SNUG". THE PROMUS ELEMENT PLUS STENT NEVER ENTERED THE PATIENT'S BODY. AS THEY WERE TAKING OFF THE WIRE THEY HAD TO PULL AND THE CATHETER SNAPPED APART. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE SHAFT BREAK OCCURRED. A 2.25X12MM PROMUS ELEMENT PLUS STENT WAS SELECTED AND FLUSHED WHILE AN UNKNOWN WIRE WAS WIPED DOWN BEFORE USE. AS THEY WERE ADVANCING THE PROMUS ELEMENT PLUS,MR,US 2.25X12MM ON THE UNKNOWN WIRE IT BECAME VERY "SNUG". THE PROMUS ELEMENT PLUS STENT NEVER ENTERED THE PATIENT'S BODY. AS THEY WERE TAKING OFF THE WIRE THEY HAD TO PULL AND THE CATHETER SNAPPED APART. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145337 PROMUS ELEMENT? PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911412220 15689423

    Patients

    Seq Age Sex Outcome Treatment
    1