BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT? PLUS

    MDR report key: 3061733 · Received April 16, 2013

    Report

    Report Number
    2134265-2013-02372
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    March 19, 2013
    Report Date
    March 19, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: VISUAL EXAMINATION OF THE RETURNED STENT DELIVERY SYSTEM FOUND A SHAFT POLYMER EXTRUSION BREAK LOCATED APPROXIMATELY 240MM PROXIMAL FROM THE TIP OF THE CATHETER. THEREFORE, THE DEVICE WAS RECEIVED IN TWO SECTIONS AS A RESULT OF THIS BREAK. A GUIDEWIRE WAS RETURNED STILL INSERTED IN THE LUMEN OF THE DEVICE. ALL ATTEMPTS TO REMOVE THE GUIDEWIRE FAILED DUE TO THE EXTENT OF THE DAMAGE PRESENT. FURTHER REVIEW FOUND CONSIDERABLE SHAFT POLYMER EXTRUSION DAMAGE JUST PROXIMAL FROM THE STENT AND BALLOON, AS THE OUTER PROFILE OF THE SHAFT WAS KINKED AND ALSO BUNCHED INTERMITTENTLY. VISUAL EXAMINATION OF THE STENT FOUND THAT THE STENT STRUTS WERE FLARED OUTWARDLY AND BUNCHED, AT ITS PROXIMAL EDGE. THE PROFILE OF THE BALLOON ALSO APPEARED TO BE BUNCHED AT THIS POINT ALSO. NO FURTHER DAMAGE WAS NOTED ON THE RETURNED 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

    DEVICE IS A COMBINATION PRODUCT. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS: 2134265-2013-02700. IT WAS REPORTED THAT DURING A LOWER LEG EXTREMITY TREATMENT PROCEDURE, A SHAFT BREAK OCCURRED. THE TARGET LESION BEING TREATED WAS LOCATED IN THE PERITONEAL ARTERY. A NON-BSC GUIDEWIRE WAS POSITIONED IN THE TARGET LESION AND AN ATTEMPT WAS MADE TO ADVANCE THE 4.00X16MM PROMUS ELEMENT PLUS STENT BUT IT WAS STUCK ON THE WIRE NEAR THE EXIT OF THE SHEATH. AS THE DEVICE WAS PULLED OUT, THE SHAFT BROKE BUT THE DOCTOR WAS ABLE TO RETRIEVE IT. THE DEVICE WAS THEN REPLACED WITH A 4.0X20MM PROMUS ELEMENT PLUS STENT. THE DOCTOR ATTEMPTED TO ADVANCE THE SECOND STENT HOWEVER, IT WAS STUCK AGAIN ON THE WIRE INSIDE THE SHEATH. THE DEVICE WAS PULLED OUT AND THE SHAFT WAS NOTED TO BE "TINNED OUT". THE DEVICE WAS REPLACED WITH A DIFFERENT DEVICE AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT¿S STATUS WAS FINE.

    Description of Event or Problem · 1

    SAME CASE AS: 2134265-2013-02700. IT WAS REPORTED THAT DURING A LOWER LEG EXTREMITY TREATMENT PROCEDURE, A SHAFT BREAK OCCURRED. THE TARGET LESION BEING TREATED WAS LOCATED IN THE PERITONEAL ARTERY. A NON-BSC GUIDEWIRE WAS POSITIONED IN THE TARGET LESION AND AN ATTEMPT WAS MADE TO ADVANCE THE 4.00X16MM PROMUS ELEMENT PLUS STENT BUT IT WAS STUCK ON THE WIRE NEAR THE EXIT OF THE SHEATH. AS THE DEVICE WAS PULLED OUT, THE SHAFT BROKE BUT THE DOCTOR WAS ABLE TO RETRIEVE IT. THE DEVICE WAS THEN REPLACED WITH A 4.0X20MM PROMUS ELEMENT PLUS STENT. THE DOCTOR ATTEMPTED TO ADVANCE THE SECOND STENT HOWEVER, IT WAS STUCK AGAIN ON THE WIRE INSIDE THE SHEATH. THE DEVICE WAS PULLED OUT AND THE SHAFT WAS NOTED TO BE "TINNED OUT". THE DEVICE WAS REPLACED WITH A DIFFERENT DEVICE AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162331 PROMUS ELEMENT? PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911416400 15633552

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR GUIDE WIRE: WHISPER EXTRA SUPPORT