BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT¿ PLUS

    MDR report key: 2840308 · Received November 20, 2012

    Report

    Report Number
    2134265-2012-07210
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Report Date
    October 26, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED 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 DURING A STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. THE PROCEDURE TREATED THE TARGET LESION LOCATED IN AN UNSPECIFIED LOCATION. PRE-DILATION WAS PERFORMED WITH AN EMERGE BALLOON CATHETER. NEXT A 3.0 X 20 MM PROMUS ELEMENT PLUS STENT WAS ADVANCED FOR TREATMENT BUT THE PHYSICIAN HAD TROUBLE DELIVERING THE STENT AND PULLED IT OUT OF THE PATIENT'S BODY. UPON EXAMINATION, IT WAS NOTED THAT THE PROXIMAL END OF THE STENT WAS FLARED. THE LESION WAS PRE-DILATED AGAIN WITH AN EMERGE BALLOON CATHETER AND ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS OCCURRED AND THE PATIENT STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS ELEMENT¿ PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493911420300 15340468

    Patients

    Seq Age Sex Outcome Treatment
    1