BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT¿ PLUS

    MDR report key: 3090661 · Received May 2, 2013

    Report

    Report Number
    2134265-2013-03218
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    April 3, 2013
    Report Date
    April 5, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. (B)(4). DEVICE EVALUATED BY MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A STENT WAS MOVED ON THE BALLOON. THE TARGET LESION BEING TREATED WAS LOCATED IN THE VERY TORTUOUS AND HIGHLY CALCIFIED MID RIGHT CORONARY ARTERY (RCA). A 3.0 X 15MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED TO THE LESION FOR PRE-DILATION. AFTER, AN ATTEMPT WAS MADE TO POSITION THE 3.00X28MM PROMUS ELEMENT STENT INTO THE TARGET VESSEL HOWEVER, THE STENT MOVED ON THE BALLOON. THE PHYSICIAN THEN CAREFULLY REMOVED THE STENT DELIVERY SYSTEM WITH THE STENT THAT WAS NOTED TO "HANG UP IN CALCIUM". ALL THE PARTS WERE PULLED OUT INCLUDING THE GUIDE CATHETER, GUIDEWIRE AND THE STENT DELIVERY SYSTEM (SDS) WITH THE STENT BARELY HANGING ON THE BALLOON. NOTHING WAS LEFT INSIDE THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS LISTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192589 PROMUS ELEMENT¿ PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911428300

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR BALLOON CATHETER: 3.0 X15 QUANTUM MAVERICK