BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT ¿

    MDR report key: 2821599 · Received November 6, 2012

    Report

    Report Number
    2134265-2012-07122
    Event Type
    Malfunction
    Date Received
    November 6, 2012
    Date of Event
    October 9, 2012
    Report Date
    October 9, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPDATE: DEVICE EVALUATED BY MFR, EVAL SUMMARY ATTACHED, METHOD CODES, RESULT CODES, CONCLUSION CODES. DEVICE EVALUATED BY MANUFACTURER: A VISUAL AND MICROSCOPIC EXAMINATION IDENTIFIED TIP DAMAGE. THE EDGE OF THE TIP WAS BENT BACK. THIS TYPE OF DAMAGE IS CONSISTENT WITH THE TIP BEING PUSHED UP AGAINST A RESTRICTION, DURING ATTEMPTS TO CROSS THE LESION. THE STRUTS ON ROWS 6 TO 11 FROM THE PROXIMAL EDGE WERE SEVERELY MISALIGNED AND PUSHED APART. THE STRUTS ON THE DISTAL END OF THE STENT WAS BUNCHED UP. THE STENT HAD MOVED FORWARD DISTALLY ON THE BALLOON BY 3MM. SOME OF THE STRUTS WERE RAISED UP. THE BALLOON WAS TIGHTLY WRAPPED AND WAS NOT SUBJECTED TO POSITIVE PRESSURE. NO KINKS OR DAMAGE WERE NOTICED ALONG THE SHAFT OF THE DEVICE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED 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 STENTING TREATMENT PROCEDURE, THE STENT MOVED ON THE BALLOON. USING THE RADIAL APPROACH, THE PROCEDURE TREATED THE DE NOVO, ECCENTRIC 3.5X23MM TARGET LESION, LOCATED IN THE MILDLY CALCIFIED AND SEVERELY TORTUOUS LEFT ANTERIOR DESCENDING (LAD) ARTERY. AFTER PRE-DILATION, A 3.5X24MM PROMUS ELEMENT STENT WAS ADVANCED FOR TREATMENT BUT THE STENT MOVED ON THE BALLOON AFTER GETTING STUCK AT THE EDGE OF THE EXTENSION CATHETER, WHILE INSIDE THE GUIDE CATHETER. THE DEVICE WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH A 3.5X23MM UNSPECIFIED STENT, PLACED IN THE MID LAD ARTERY AND A 3.0X12MM UNSPECIFIED STENT PLACED IN THE DISTAL LAD ARTERY. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, THE STENT MOVED ON THE BALLOON. USING THE RADIAL APPROACH, THE PROCEDURE TREATED THE DE NOVO, ECCENTRIC 3.5X23MM TARGET LESION LOCATED IN THE MILDLY CALCIFIED AND SEVERELY TORTUOUS LEFT ANTERIOR DESCENDING (LAD) ARTERY. AFTER PRE-DILATION, A 3.5X24MM PROMUS ELEMENT STENT WAS ADVANCED FOR TREATMENT BUT THE STENT MOVED ON THE BALLOON AFTER GETTING STUCK AT THE EDGE OF THE EXTENSION CATHETER WHILE INSIDE THE GUIDE CATHETER. THE DEVICE WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH A 3.5X23MM UNSPECIFIED STENT PLACED IN THE MID LAD ARTERY AND A 3.0X12MM UNSPECIFIED STENT PLACED IN THE DISTAL LAD ARTERY. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS ELEMENT ¿ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911324350 15102794

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR 3.5 EBU 6FR GUIDE CATHETER| WHISPER ES GUIDE WIRE