BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

    MDR report key: 3894441 · Received June 25, 2014

    Report

    Report Number
    2134265-2014-03620
    Event Type
    Death
    Date Received
    June 25, 2014
    Date of Event
    January 27, 2013
    Report Date
    May 28, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT DEVICE EVALUATED BY MFR: THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE 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

    SAME CASE AS MDR ID: 2134265-2014-03624 & 2134265-2014-03625. (B)(4) TRIAL. IT WAS REPORTED THAT A DEATH OCCURRED. IN (B)(6) 2009, THE PATIENT PRESENTED WITH UNSTABLE ANGINA AND THEY WERE REFERRED FOR CARDIAC CATHETERIZATION. THE PATIENT HAD A 70% STENOSED LESION WITH A LENGTH OF 5 MM AND REFERENCE VESSEL DIAMETER OF 3.5 MM LOCATED IN THE DISTAL LEFT CIRCUMFLEX ARTERY (LCX) THAT WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 3.50 X 12 MM STUDY STENT WITH 0% RESIDUAL STENOSIS. THE PATIENT ALSO HAD A 70% STENOSED LESION WITH A LENGTH OF 11 MM AND REFERENCE VESSEL DIAMETER OF 3.5 MM LOCATED IN THE DISTAL LEFT CIRCUMFLEX ARTERY (LCX) THAT WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 3.50 X 20 MM STUDY STENT WITH 0% RESIDUAL STENOSIS. IN ADDITION, THE PATIENT HAD A NON-TARGET LESION IN THE 1ST OM WHICH WAS TREATED WITH THE PLACEMENT OF A 2.25 X 12 MM TAXUS EXPRESS2 ATOM PACLITAXEL-ELUTING CORONARY STENT SYSTEM DURING THE INDEX PROCEDURE. THE SUBJECT WAS DISCHARGED THE NEXT DAY ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2010, THE PATIENT HAD A 70% STENOSED LESION IN THE PROXIMAL LCX THAT WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF 3.5 X 18 MM PROMUS STENT EXTENDING IN TO THE LMCA WITH 0% RESIDUAL STENOSIS. IN JANUARY 2013, THE PATIENT DIED AT HOME FROM MYOCARDIAL INFARCTION (MI).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371526 PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911512350 12244993

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death