BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

    MDR report key: 3875292 · Received June 16, 2014

    Report

    Report Number
    2134265-2014-03302
    Event Type
    Death
    Date Received
    June 16, 2014
    Date of Event
    March 14, 2014
    Report Date
    May 20, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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 RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID: 2134265-2014-03308. (B)(4) CLINICAL STUDY. IT WAS REPORTED THAT CARDIAC ARREST AND PATIENT DEATH OCCURRED. IN (B)(6) 2009, THE PATIENT PRESENTED DUE TO UNSTABLE ANGINA AND THE SUBJECT WAS REFERRED TO CARDIAC CATHETERIZATION. INDEX PROCEDURE WAS PERFORMED. THE TARGET LESION #1 WAS LOCATED IN THE RAMUS WITH 95% STENOSIS, A LENGTH OF 16 MM AND A REFERENCE VESSEL DIAMETER OF 2.5 MM. THE LESION WAS TREATED WITH PRE-DILATATION, PLACEMENT OF A 2.50 X 20 MM STUDY STENT, AND POST-DILATATION WITH 0% RESIDUAL STENOSIS. TARGET LESION #2 WAS LOCATED IN RAMUS WITH 70% STENOSIS, A LENGTH OF 16 MM AND A REFERENCE VESSEL DIAMETER OF 2.5 MM. THE LESION WAS TREATED WITH PRE-DILATATION, PLACEMENT OF A 2.50 X 20 MM STUDY STENT, AND POST-DILATATION WITH 0% RESIDUAL STENOSIS. ONE DAY POST PROCEDURE, THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2014, CARDIAC ARREST OCCURRED AND THE PATIENT DIED ON THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352851 PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911520250 12208774

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death