BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2023426 · Received March 18, 2011

    Report

    Report Number
    2134265-2011-00732
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    February 18, 2011
    Report Date
    February 21, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER: A VISUAL AND MICROSCOPIC EXAMINATION IDENTIFIED THAT THE STENT WAS RETURNED WITHOUT THE DELIVERY SYSTEM. THE STENT WAS STRETCHED ALONG IT'S LENGTH AND MEASURED 64MM. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS USE ERROR AS 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." (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, STENT DISLODGEMENT OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED RIGHT CORONARY ARTERY (RCA). AFTER PREDILATING THE LESION, THE STENOSIS WAS REDUCED TO 80%. NEXT, A 2.75X28MM A PROMUS ELEMENT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED BUT COULD NOT CROSS THE LESION. AFTER TRYING TO CROSS THE LESION 4-5 TIMES, THE SDS WAS PULLED BACK INTO THE GUIDECATHETER. DURING REMOVAL THE STENT GOT DAMAGED AND DISLODGED INSIDE THE GUIDE CATHETER. THE STENT WAS SUCCESSFULLY RETRIEVED BY REMOVING THE GUIDE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE. THIS PRODUCT 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, STENT DISLODGEMENT OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED RIGHT CORONARY ARTERY (RCA). AFTER PREDILATING THE LESION, THE STENOSIS WAS REDUCED TO 80%. NEXT, A 2.75X28MM A PROMUS ELEMENT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED BUT COULD NOT CROSS THE LESION. AFTER TRYING TO CROSS THE LESION 4-5 TIMES, THE SDS WAS PULLED BACK INTO THE GUIDECATHETER. DURING REMOVAL THE STENT GOT DAMAGED AND DISLODGED INSIDE THE GUIDE CATHETER. THE STENT WAS SUCCESSFULLY RETRIEVED BY REMOVING THE GUIDE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE. THIS PRODUCT 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 H7493911328270 13877246

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR CORDIS VISTA BRIGHT TIP GUIDE CATHETER| TERUMO RUNTHROUGH GUIDE WIRE