BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT ¿

    MDR report key: 2831334 · Received November 14, 2012

    Report

    Report Number
    2134265-2012-06936
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    October 17, 2012
    Report Date
    October 17, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPDATED: DEVICE EVALUATED BY MANUFACTURER, EVALUATION SUMMARY ATTACHED, METHOD CODES, RESULTS CODES, AND CONCLUSION CODES DEVICE EVALUATED BY MANUFACTURER: DEVICE WAS RETURNED FOR EVALUATION. A VISUAL AND MICROSCOPIC EXAMINATION NOTED PROXIMAL STENT DAMAGE. ONE STRUT OF THE MOST PROXIMAL ROW WAS BENT OUTWARDS. THE HYPOTUBE WAS KINKED AT VARIOUS LOCATIONS ALONG ITS LENGTH. TRACES OF BLOOD WERE VISIBLE AROUND THE TIP AREA INDICATING THE DEVICE WAS USED IN VIVO. 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

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4). DEVICE IS COMBINATION PRODUCT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, STENT DAMAGE OCCURRED. A 2.5 X 16 MM PROMUS ELEMENT STENT WAS SELECTED AND ADVANCED TO TREAT THE SEVERELY CALCIFIED LESION. SEVERAL ATTEMPTS WERE MADE TO CROSS THE LESION; HOWEVER, THE DEVICE WAS NOT ABLE TO CROSS THE TARGET LESION. THE DEVICE WAS REMOVED AND READVANCED THROUGH A NON-BSC CATHETER. THE DISTAL EDGE OF THE STENT CAME IN CONTACT WITH THE NON-BSC CATHETER. UPON REMOVAL, THE DISTAL EDGE OF THE STENT APPEARED FLARED OUT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME PROMUS ELEMENT STENT WITH THE SAME NON-BSC CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, STENT DAMAGE OCCURRED. A 2.5 X 16 MM PROMUS ELEMENT STENT WAS SELECTED AND ADVANCED TO TREAT THE SEVERELY CALCIFIED LESION. SEVERAL ATTEMPTS WERE MADE TO CROSS THE LESION; HOWEVER, THE DEVICE WAS NOT ABLE TO CROSS THE TARGET LESION. THE DEVICE WAS REMOVED AND READVANCED THROUGH A NON-BSC CATHETER. THE DISTAL EDGE OF THE STENT CAME IN CONTACT WITH THE NON-BSC CATHETER. UPON REMOVAL, THE DISTAL EDGE OF THE STENT APPEARED FLARED OUT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME PROMUS ELEMENT STENT WITH THE SAME NON-BSC CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS ELEMENT ¿ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911316250 15328611

    Patients

    Seq Age Sex Outcome Treatment
    1