BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT ?

    MDR report key: 3061226 · Received April 16, 2013

    Report

    Report Number
    2134265-2013-02809
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    March 18, 2013
    Report Date
    March 18, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR., EVAL SUMMARY ATTACHED, DATE REC'D BY MFR., METHOD CODES, RESULT CODES, CONCLUSION CODES UPDATED. DEVICE EVALUATED BY MFR.: A VISUAL AND MICROSCOPIC EXAMINATION IDENTIFIED STENT DAMAGE. THE STENT WAS STRETCHED ALONG ITS LENGTH CAUSING THE STENT TO BE PUSHED OUT TOWARDS THE TIP OF THE DEVICE. THE DAMAGE CAUSED SOME OF THE STRUTS TO BE RAISED UP. THE BALLOON AND THE TIP 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 ANY POSITIVE PRESSURE. THE HYPOTUBE HAD KINKED APPROXIMATELY 670MM AND 830MM DISTAL FROM THE CATHETER'S STRAIN RELIEF. SEVERAL SMALLER KINKS WERE NOTED ALONG THE LUMEN OF THE DEVICE. NO OTHER ISSUES WERE NOTED WITH 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 A CORONARY ARTERY STENTING TREATMENT PROCEDURE, A STENT DAMAGE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT FEMORAL ARTERY. THE 80% STENOSED, ECCENTRIC, 12MM IN LENGTH, 3.5MM IN DIAMETER, DE NOVO TARGET LESION WAS LOCATED IN A NON-TORTUOUS LEFT ANTERIOR DESCENDING ARTERY. A 3.5X15MM APEX BALLOON CATHETER WAS USED TO PREDILATE THE TARGET LESION. THE TARGET LESION'S STENOSIS REDUCED TO 50% IMMEDIATELY AFTER PRE-DILATION. A 3.50X12MM PROMUS ELEMENT DUG-ELUTING STENT ADVANCED TO THE TARGET LESION. THE PHYSICIAN ENCOUNTERED SIGNIFICANT RESISTANCE UPON ADVANCEMENT TO THE LESION. THE DEVICE WAS REMOVED AND IT WAS NOTICED THAT THE STENT WAS DEFORMED. A 3.0X24MM PROMUS ELEMENT STENT WAS IMPLANTED IN THE TARGET LESION. A 3.5X15MM QUANTUM BALLOON CATHETER WAS USED TO POST DILATE THE TARGET LESION. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY ARTERY STENTING TREATMENT PROCEDURE, A STENT DAMAGE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT FEMORAL ARTERY. THE 80% STENOSED, ECCENTRIC, 12MM IN LENGTH, 3.5MM IN DIAMETER, DE NOVO TARGET LESION WAS LOCATED IN A NON-TORTUOUS LEFT ANTERIOR DESCENDING ARTERY. A 3.5X15MM APEX BALLOON CATHETER WAS USED TO PREDILATE THE TARGET LESION. THE TARGET LESION'S STENOSIS REDUCED TO 50% IMMEDIATELY AFTER PRE-DILATION. A 3.50X12MM PROMUS ELEMENT DUG-ELUTING STENT ADVANCED TO THE TARGET LESION. THE PHYSICIAN ENCOUNTERED SIGNIFICANT RESISTANCE UPON ADVANCEMENT TO THE LESION. THE DEVICE WAS REMOVED AND IT WAS NOTICED THAT THE STENT WAS DEFORMED. A 3.0X24MM PROMUS ELEMENT STENT WAS IMPLANTED IN THE TARGET LESION. A 3.5X15MM QUANTUM BALLOON CATHETER WAS USED TO POST DILATE THE TARGET LESION. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161912 PROMUS ELEMENT ? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911312350 15469699

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR