BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT¿ PLUS

    MDR report key: 2842650 · Received November 21, 2012

    Report

    Report Number
    2134265-2012-07134
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Report Date
    October 31, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. (B)(4). DEVICE EVALUATED BY MFR: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: RETURNED PRODUCT CONSISTED OF A PROMUS ELEMENT PLUS STENT DELIVERY SYSTEM (SDS) AND STENT WITH THE STENT PROTECTOR AND PRODUCT MANDREL PARTIALLY LOADED. THERE WAS CONTRAST IN THE INFLATION LUMEN. THE PRESENCE OF CONTRAST IN THE INFLATION LUMEN, AND THE POSITION OF THE STENT PROTECTOR AND PRODUCT MANDREL SUGGEST THE STENT PROTECTOR AND PRODUCT MANDREL WERE REPLACED AFTER THE REPORTED STENT DAMAGE. THE STENT HAD MOVED ON THE BALLOON 4MM DISTALLY OF THE PROXIMAL MARKERBAND; THERE WAS NO INDICATION THE DEVICE WAS SUBJECTED TO POSITIVE (INFLATION) PRESSURE. THE LOCATION OF THE STRUT IMPRESSIONS ON THE BALLOON INDICATES THE STENT WAS APPROPRIATELY POSITIONED AND SECURED TO THE BALLOON IN MANUFACTURING. THERE WERE MULTIPLE STENT STRUTS BUNCHED UP AND BENT IN THE MIDDLE OF THE STENT. THE SHAFT WAS DETACHED/SEPARATED 36.5CM FROM THE DISTAL TIP; THE MATERIAL WAS JAGGED AND STRETCHED, WHICH SUGGESTS THAT THE SEPARATION MAY BE RELATED TO TENSILE OVERLOAD (MATERIAL STRESS/FATIGUE). MAGNIFIED INSPECTION PRESENTED NO DAMAGE OR IRREGULARITIES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE CONFIRMED STENT DAMAGE, STENT MOVED ON BALLOON AND SHAFT DETACHMENT. 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/PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT A STENTING TREATMENT PROCEDURE A STENT DELIVERY SYSTEM WAS DAMAGED AND CAME APART. THE 4.0 X 28 MM PROMUS ELEMENT PLUS DELIVERY SYSTEM WAS POSSIBLY USED AT A STENTING TREATMENT PROCEDURE. THE DESCRIPTION ON THE BOX STATED, "CAME APART, SWAPPED, DAMAGED." NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE A STENT DELIVERY SYSTEM WAS DAMAGED AND CAME APART. THE 4.0 X 28MM PROMUS ELEMENT PLUS DELIVERY SYSTEM WAS POSSIBLY USED AT A STENTING TREATMENT PROCEDURE. THE DESCRIPTION ON THE BOX STATED, "CAME APART, SWAPPED, DAMAGED." NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS ELEMENT¿ PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493911428400 15411645

    Patients

    Seq Age Sex Outcome Treatment
    1