BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT ¿ LONG

    MDR report key: 2820240 · Received November 6, 2012

    Report

    Report Number
    2134265-2012-06592
    Event Type
    Malfunction
    Date Received
    November 6, 2012
    Date of Event
    October 8, 2012
    Report Date
    October 8, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. (B)(4). DEVICE EVALUATED BY MFR: 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 DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE, STENT DAMAGE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE RADIAL ARTERY. THE 80% STENOSED, 3.0 X 80 MM, ECCENTRIC, DE NOVO TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED RIGHT CORONARY ARTERY (RCA). ROTATIONAL ARTHRECTOMY WAS PERFORMED WITH A 1.5 MM ROTABLATOR BURR. THE LESION WAS PREDILATED WITH A 2.5 X 15 MM EMERGE BALLOON CATHETER. A 2.5 X 38 MM PROMUS ELEMENT DRUG ELUTING STENT (DES) WAS SELECTED AND ADVANCED TO TREAT THE TARGET LESION; HOWEVER DIFFICULTY ADVANCING THE DEVICE OCCURRED. A NON-BSC CATHETER WAS ADVANCED FOR SUPPORT; HOWEVER, WHILE ATTEMPTING TO ADVANCE THE 2.5 X 38 MM PROMUS ELEMENT DES THROUGH THE NON-BSC CATHETER, RESISTANCE WAS FELT. THE DES WAS REMOVED AND IT WAS NOTED THAT SOME OF THE PROXIMAL STENT STRUTS APPEARS SLIGHTLY LIFTED. THE PROCEDURE WAS COMPLETED WITH THE IMPLANT A 2.5 X 38 MM PROMUS ELEMENT DES AND TWO 3.0 X 28 PROMUS ELEMENT DES. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS ELEMENT ¿ LONG STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911338250 0015398989

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR