BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT? PLUS

    MDR report key: 3220887 · Received July 11, 2013

    Report

    Report Number
    2134265-2013-04711
    Event Type
    Injury
    Date Received
    July 11, 2013
    Date of Event
    April 5, 2013
    Report Date
    June 12, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR.: THE COMPLAINT 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). IT WAS REPORTED THAT POST A CORONARY STENTING PROCEDURE, THE PATIENT EXPERIENCED ANGINA AND TARGET VESSEL REVASCULARIZATION OCCURRED. IN (B)(6) 2012, THE SUBJECT PRESENTED DUE TO UNSTABLE ANGINA AND UNDERWENT CARDIAC CATHETERIZATION WHICH REVEALED A DE NOVO TARGET LESION LOCATED IN THE 1ST RIGHT POSTEROLATERAL (RPL) ARTERY WITH 90% STENOSIS AND WAS 25 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.25 MM. IT WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.25 X 28 MM PE PLUS STENT. FOLLOWING POST-DILATATION RESIDUAL STENOSIS WAS 0%. THE SUBJECT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL THE FOLLOWING DAY. ON (B)(6) 2013, THE SUBJECT PRESENTED WITH UNSTABLE ANGINA AND WAS HOSPITALIZED ON THE SAME DAY. SUBSEQUENTLY, THE SUBJECT UNDERWENT CARDIAC CATHETERIZATION WHICH REVEALED A, 99% IN-STENT RE-STENOTIC LESION IN THE RIGHT POSTERIOR DESCENDING ARTERY (R-PDA). IT WAS TREATED WITH DIRECT STENT PLACEMENT USING A 2.25 X 12 MM PROMUS ELEMENT STENT. FOLLOWING POST-DILATATION, THERE WAS NO RESIDUAL STENOSIS NOTED AT POST-INTERVENTIONAL ANGIOGRAPHY. ALSO, THE 80% TUBULAR IN-STENT RE-STENOSIS OF THE STUDY STENT LOCATED IN THE 1ST RPL WAS TREATED WITH DIRECT STENT PLACEMENT USING A 2.25 X 12 MM PROMUS ELEMENT STENT WITH NO RESIDUAL STENOSIS NOTED AT POST-INTERVENTIONAL ANGIOGRAPHY. THE EVENT WAS CONSIDERED TO BE RESOLVED AND THE SUBJECT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL THE NEXT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321143 PROMUS ELEMENT? PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493911428220 15109401

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R