BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1896982 · Received November 11, 2010

    Report

    Report Number
    2134265-2010-04937
    Event Type
    Malfunction
    Date Received
    November 11, 2010
    Date of Event
    October 9, 2010
    Report Date
    October 15, 2010
    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

    DEVICE EVALUATED BY MANUFACTURER - THE BSC PACKAGING BOX WAS RETURNED WHICH CONTAINED AN EMPTY INNER FOIL POUCH, AN EMPTY PLASTIC POUCH AND A BOOKLET. THE DEVICE WAS NOT INCLUDED IN WITH THE PACKAGING. AS THE UNIT HAS NOT BEEN RETURNED A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED USE/USER ERROR. THE DFU STATES DO NOT ATTEMPT TO PULL AN UNEXPANDED STENT BACK INTO THE GUIDE CATHETER, AS STENT OR COATING DAMAGE OR STENT DISLODGMENT FROM THE BALLOON MAY OCCUR. NO FURTHER ESCALATION IS REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A STENT DISLODGEMENT OCCURRED. THE 80% STENOSED ECCENTRIC LESION MEASURING 3.0MM IN DIAMETER WAS LOCATED IN A MODERATELY TORTUOUS AND MODERATE TO SEVERELY CALCIFIED RIGHT CORONARY ARTERY. THE LESION WAS PREDILATED WITH A MAVERICK BALLOON. A 3.0X16MM PROMUS ELEMENT STENT WAS ADVANCED TO THE LESION BUT COULD NOT CROSS. THE PHYSICIAN ATTEMPTED TO PULL THE STENT BACK INTO THE GUIDE CATHETER AND THE DEVICE WAS REMOVED WITH SOME WITHDRAWAL DIFFICULTIES. AS THE STENT DELIVERY SYSTEM WAS REMOVED, THE STENT FELL OFF IN THE NURSES' HANDS. THE PROCEDURE WAS COMPLETED BY PREDILATION WITH ANOTHER BALLOON AND PLACEMENT OF A PROMUS ELEMENT STENT. NO PATIENT COMPLICATIONS WERE REPORTED. PATIENT STATUS IS LISTED AS STABLE. ADDITIONAL INFORMATION WAS REQUESTED, BUT IS NOT AVAILABLE. THIS DEVICE IS ONLY OUS APPROVED, BUT IT IS SIMILAR TO AN APPROVED US DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A STENT DISLODGEMENT OCCURRED. THE 80% STENOSED ECCENTRIC LESION MEASURING 3.0MM IN DIAMETER WAS LOCATED IN A MODERATELY TORTUOUS AND MODERATE TO SEVERELY CALCIFIED RIGHT CORONARY ARTERY. THE LESION WAS PREDILATED WITH A MAVERICK BALLOON. A 3.0X16MM PROMUS ELEMENT STENT WAS ADVANCED TO THE LESION BUT COULD NOT CROSS. THE PHYSICIAN ATTEMPTED TO PULL THE STENT BACK INTO THE GUIDE CATHETER AND THE DEVICE WAS REMOVED WITH SOME WITHDRAWAL DIFFICULTIES. AS THE STENT DELIVERY SYSTEM WAS REMOVED, THE STENT FELL OFF IN THE NURSES' HANDS. THE PROCEDURE WAS COMPLETED BY PREDILATION WITH ANOTHER BALLOON AND PLACEMENT OF A PROMUS ELEMENT STENT. NO PATIENT COMPLICATIONS WERE REPORTED. PATIENT STATUS IS LISTED AS STABLE. ADDITIONAL INFORMATION WAS REQUESTED, BUT IS NOT AVAILABLE. THIS DEVICE IS ONLY OUS APPROVED, BUT IT IS SIMILAR TO AN APPROVED US DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911316300 13589392

    Patients

    Seq Age Sex Outcome Treatment
    1 BMW GUIDE WIRE| LAUNCHER GUIDE CATHETER| MAVERICK BALLOON