BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT? PLUS

    MDR report key: 3061899 · Received April 16, 2013

    Report

    Report Number
    2134265-2013-02700
    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 MFR., EVAL SUMMARY ATTACHED, METHOD CODES, RESULT CODES, CONCLUSION CODES UPDATED.  DEVICE EVALUATED BY MANUFACTURER: INITIAL VISUAL EXAMINATION NOTED THAT THE SHAFT WAS SEVERELY KINKED JUST PROXIMAL TO THE EXCHANGE PORT. THE PROFILE OF THE SHAFT RESEMBLED A 'HORSESHOE/LOOP' SHAPE AND BOTH THE OUTER AND INNER WERE KINKED AT INTERMITTENT INTERVALS RUNNING APPROXIMATELY 50 MM PROXIMAL FROM THE PORT. THE REMAINDER OF THE HYPOTUBE HAD MINOR KINKING AT VARIOUS INTERVALS ALONG ITS LENGTH. DUE TO THE CONDITION OF THE RETURNED UNIT, THE GUIDEWIRE FAILED TO TRACK FULLY WITHIN THE LUMEN OF THE DEVICE. THE BALLOON AND STENT 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 ANY POSITIVE PRESSURE. 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: 2134265-2013-02372. 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

    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 4.00X16 MM 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 4.0X20 MM 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
    163963 PROMUS ELEMENT? PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911420400 15803254

    Patients

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