BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT ¿

    MDR report key: 2863114 · Received December 10, 2012

    Report

    Report Number
    2134265-2012-07276
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    November 7, 2012
    Report Date
    November 7, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. AGE AT TIME OF EVENT: 60'S. (B)(4). DEVICE EVALUATED BY MFR.: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. 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. THE 75% STENOSED LESION WAS LOCATED IN MILDLY CALCIFIED AND MODERATELY TORTUOUS DISTAL RIGHT CORONARY ARTERY (RCA). THE LESION LENGTH WAS ABOUT 18MM, THE VESSEL DIAMETER WAS ABOUT 2.7MM AND A SIGNIFICANT BEND UNDER 45. THE LESION WAS PRE-DILATED WITH A 2.25MM NON-BSC BALLOON CATHETER AT 6 TO 8 ATMS FOR 20 SEC FROM DISTAL TO PROXIMAL SEVERAL TIMES. A 2.50X20MM PROMUS ELEMENT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED BUT WOULD NOT CROSS. WHEN THE SDS WAS REMOVED, IT WAS NOTED THAT THE DISTAL STENT WAS DAMAGED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. 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 ¿ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911320250 15085711

    Patients

    Seq Age Sex Outcome Treatment
    1 7F MACH1 FR3.5SH GUIDE CATHETER| RUNTHROUGH NS GUIDE WIRE| 2.25MM LIFEPIA BALLOON CATHETER