BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT¿ PLUS

    MDR report key: 2895325 · Received January 3, 2013

    Report

    Report Number
    2134265-2012-08233
    Event Type
    Injury
    Date Received
    January 3, 2013
    Date of Event
    November 8, 2012
    Report Date
    December 7, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    (B)(4). SAME CASE AS MDR ID#: 2134265-2012-08232. IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY STENTING TREATMENT PROCEDURE, THE PATIENT HAD CONGESTIVE HEART FAILURE. IN (B)(6) 2012, THE PATIENT PRESENTED WITH STABLE ANGINA (CCS CLASSIFICATION 1) AND WAS REFERRED FOR CARDIAC CATHETERIZATION. THE 1ST TARGET LESION WAS AN IN-STENT RESTENOSIS OF A PREVIOUSLY PLACED PROMUS STENT LOCATED IN THE SAPHENOUS VEIN GRAFT (SVG) OF THE 2ND OBTUSE MARGINAL BRANCH (OM2) WITH 90% STENOSIS AND WAS 10MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.0MM. THE PHYSICIAN TREATED THE LESION WITH DIRECT PLACEMENT OF A 3.00X16MM PROMUS ELEMENT PLUS STENT, WITH 0% RESIDUAL STENOSIS. THE 2ND TARGET LESION WAS AN IN-STENT RESTENOSIS OF A PREVIOUSLY PLACED NON-BSC DRUG-ELUTING STENT IN THE PROXIMAL LEFT CIRCUMFLEX ARTERY (PROX LCX). THE LEFT MAIN CORONARY ARTERY (LMCA) HAD A NEW LESION WITH 70% STENOSIS AND WAS 25MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.5MM. THE PHYSICIAN TREATED THE LESION WITH DIRECT PLACEMENT OF A 2.50X28MM PROMUS ELEMENT PLUS STENT COVERING LM AND ALL THE WAY INTO THE OCCLUDED LCX, WITH 0% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED ON TICAGRELOR. TWO DAYS POST INDEX PROCEDURE, THE PATIENT PRESENTED DUE TO CONGESTIVE HEART FAILURE AND WAS HOSPITALIZED ON THE SAME DAY. NO OTHER ACTION WAS TAKEN TO TREAT THE EVENT. ABOUT A WEEK LATER, THE PATIENT WAS CONSIDERED RECOVERED AND WAS DISCHARGED. THE SITE CONFIRMED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3586 PROMUS ELEMENT¿ PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911428250 15445036

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization