BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT? PLUS

    MDR report key: 3298250 · Received August 20, 2013

    Report

    Report Number
    2134265-2013-05579
    Event Type
    Injury
    Date Received
    August 20, 2013
    Date of Event
    April 26, 2013
    Report Date
    July 22, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER: (B)(6). DEVICE IS A COMBINATION PRODUCT. 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. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    (B)(6) CLINICAL STUDY. IT WAS REPORTED THAT POST PERCUTANEOUS CORONARY INTERVENTION, SIDE BRANCH EVENT OCCURRED. ON (B)(6) 2013, THE SUBJECT'S QUALIFYING CONDITION WAS UNSTABLE ANGINA AND THE SUBJECT WAS REFERRED FOR CARDIAC CATHETERIZATION WHICH REVEALED ONE TARGET LESION. TARGET LESION #1 WAS LOCATED IN THE DISTAL RIGHT CORONARY ARTERY (RCA) WITH 90% STENOSIS, A LENGTH OF 12 MM, AND REFERENCE VESSEL DIAMETER OF 3.00 MM. THE TARGET LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 3.0 X 20 MM STUDY STENT. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0%. THE BASELINE CORE LAB ANGIOGRAPHY REVEALED 30% SIDE BRANCH STENOSIS AT RIGHT POSTERIOR ATRIOVENTRICULAR (R-PAV) BRANCH. IMMEDIATELY AFTER THE PROCEDURE, ANGIOGRAPHY REVEALED 80% 'BRANCH PERCENT STENOSIS IN R-PAV. ON THE SAME DAY THE SUBJECT WAS DISCHARGED ON DUAL ANTIPLATELET THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402851 PROMUS ELEMENT? PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911420300 15615513

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other