BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT ?

    MDR report key: 3133606 · Received May 29, 2013

    Report

    Report Number
    2134265-2013-03733
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 2, 2013
    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

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

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: PROXIMAL STENT DAMAGE WAS NOTED. STRUTS ON THE FOUR MOST PROXIMAL ROWS WERE BENT OUTWARDS AND SEVERELY MISALIGNED. NO FURTHER DAMAGE. NO ISSUES WERE NOTED WITH THE TIP AND BALLOON OF THE DEVICE THAT COULD HAVE POTENTIALLY CONTRIBUTED TO THE COMPLAINT INCIDENT. 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 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 AND/ OR PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, A STENT DAMAGE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA RADIAL ARTERY. THE 90% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND SEVERELY CALCIFIED DISTAL LEFT CIRCUMFLEX ARTERY. A 2.50X24MM PROMUS ELEMENT DRUG ELUTING STENT WAS SELECTED. AFTER PREDILATING THE LESION WITH A 2.5MM NON BSC BALLOON DILATATION CATHETER, THE PROMUS ELEMENT STENT DELIVERY SYSTEM WAS ADVANCED, BUT WAS NOT ABLE TO CROSS THE TARGET LESION. THE DEVICE WAS REMOVED INTACT AND IT WAS NOTICED THAT THE PROXIMAL SIDE OF THE STENT WAS LIFTED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, A STENT DAMAGE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA RADIAL ARTERY. THE 90% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND SEVERELY CALCIFIED DISTAL LEFT CIRCUMFLEX ARTERY. A 2.50X24MM PROMUS ELEMENT DRUG ELUTING STENT WAS SELECTED. AFTER PREDILATING THE LESION WITH A 2.5MM NON BSC BALLOON DILATATION CATHETER, THE PROMUS ELEMENT STENT DELIVERY SYSTEM WAS ADVANCED, BUT WAS NOT ABLE TO CROSS THE TARGET LESION. THE DEVICE WAS REMOVED INTACT AND IT WAS NOTICED THAT THE PROXIMAL SIDE OF THE STENT WAS LIFTED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236146 PROMUS ELEMENT ? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911324250 14971269

    Patients

    Seq Age Sex Outcome Treatment
    1 SCOREFLEX2.5MM