BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT¿ PLUS

    MDR report key: 3023002 · Received March 27, 2013

    Report

    Report Number
    2134265-2013-01693
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    February 22, 2013
    Report Date
    February 26, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS NOT RECEIVED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

    Description of Event or Problem · 1

    (B)(4) STUDY. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, A VESSEL DISSECTION OCCURRED. (B)(4) 2013 THE PATIENT PRESENTED DUE TO UNSTABLE ANGINA AND WAS REFERRED FOR CARDIAC CATHETERIZATION. THE 75% STENOSED AND 30MM LONG DE-NOVO TARGET LESION WAS LOCATED IN THE MID RIGHT CORONARY ARTERY WITH A REFERENCE VESSEL DIAMETER OF 3.0MM. THE TARGET LESION WAS TREATED WITH DIRECT STENT PLACEMENT OF A 3.0X38MM PROMUS ELEMENT PLUS STENT. POST DEPLOYMENT A SUB INTIMAL GRADE "A" DISSECTION WAS NOTED AT THE PROXIMAL EDGE OF THE STENT WHICH WAS TREATED USING A 3.00 X16 MM PROMUS ELEMENT PLUS STENT IN AN OVERLAPPING FASHION WITH THE 3.0X38 MM PROMUS ELEMENT PLUS STENT, RESULTING IN 0% RESIDUAL STENOSIS. A 75% STENOSED AND 15MM LONG DE-NOVO 2ND TARGET LESION WAS LOCATED IN THE DISTAL LEFT ANTERIOR DESCENDING ARTERY WITH A REFERENCE VESSEL DIAMETER OF 2.5MM. THE 2ND TARGET LESION WAS TREATED WITH DIRECT STENT PLACEMENT OF A 2.5X20MM PROMUS ELEMENT PLUS STENT, RESULTING IN 0% RESIDUAL STENOSIS FOLLOWING POST DILATION. THE FOLLOWING DAY THE PATIENT WAS DISCHARGED ON ASPIRIN AND PRASUGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125772 PROMUS ELEMENT¿ PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911438300 15814951

    Patients

    Seq Age Sex Outcome Treatment
    1 65 Required Intervention