BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2872984 · Received December 13, 2012

    Report

    Report Number
    2134265-2012-07571
    Event Type
    Injury
    Date Received
    December 13, 2012
    Date of Event
    August 14, 2009
    Report Date
    November 15, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). DEVICE IS A COMBINATION PRODUCT (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 CONFORMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE IS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    (B)(4) STUDY. IT WAS REPORTED THAT DURING A CORONARY ARTERY STENTING TREATMENT PROCEDURE, INCOMPLETE STENT APPOSITION OCCURRED. IN (B)(6) 2009, CLINICAL STATUS ASSESSMENT IDENTIFIED THE PATIENT'S QUALIFYING CONDITION AS STABLE ANGINA (CCS CLASSIFICATION 2) AND THE PATIENT WAS REFERRED FOR CARDIAC CATHETERIZATION. THE TARGET LESION WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (PROX LAD) WITH 90% STENOSIS AND WAS 20MM LONG WITH A REFERENCE VESSEL DIAMETER OF 4.0MM. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATION USING A 3.0X20MM QUANTUM MAVERICK BALLOON AND PLACEMENT OF A 3.50X28MM PROMUS ELEMENT STENT. SINCE THE PROXIMAL PORTION OF THE TARGET VESSEL HAD A DIAMETER OF 4.5MM, THEREFORE, THERE WAS INCOMPLETE APPOSITION OF THE STUDY STENT. A 4.5X15MM QUANTUM MAVERICK BALLOON WAS USED TO DILATE THE PROXIMAL PORTION OF THE STENT AT 12 ATMOSPHERES, WHEREAS A 3.5X12MM QUANTUM MAVERICK BALLOON WAS USED TO DILATE THE DISTAL PORTION OF THE STENT AT 16 ATMOSPHERES. FOLLOWING POST DILATATION THE ULTRASOUND SHOWED IMPROVED RESULTS. RESIDUAL STENOSIS WAS 0%.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911528350 12290661

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention