BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT ¿

    MDR report key: 3002470 · Received March 13, 2013

    Report

    Report Number
    2134265-2013-01433
    Event Type
    Injury
    Date Received
    March 13, 2013
    Date of Event
    February 13, 2013
    Report Date
    February 13, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 CONSIDERED "CAUSED BY ANOTHER DEVICE." (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, STENT DEFORMATION OCCURRED. THE PROCEDURE TREATED THE 90% STENOSED TARGET LESION LOCATED IN THE CALCIFIED AND MODERATELY TORTUOUS MID RIGHT CORONARY ARTERY. AFTER PRE-DILATION, A 2.75X12MM PROMUS ELEMENT STENT WAS DEPLOYED WITH 3 INFLATIONS [12 ATMS, 18 ATMS AND 18 ATMS]. NEXT A 2.75X12MM NON-BSC BALLOON CATHETER WAS ADVANCED FOR POST DILATION BUT CAME INTO CONTACT WITH THE EDGE OF THE 2.75X12MM PROMUS ELEMENT STENT AND SHORTENED THE STENT ABOUT 2MM. TO RESOLVE THE STENT DEFORMATION, A 2.5X16MM PROMUS ELEMENT STENT WAS DEPLOYED AND THEN THE AREA WAS POST DILATED WITH A 2.75MM UNSPECIFIED BALLOON. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104913 PROMUS ELEMENT ¿ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911320270 14908144

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 2.75X12MM LA CROSSE BALLOON CATHETER