BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

    MDR report key: 3901059 · Received June 30, 2014

    Report

    Report Number
    2134265-2014-03705
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    June 1, 2014
    Report Date
    June 3, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: THE DEVICE WAS NOT RETURNED FOR EVALUATION. 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) STUDY. IT WAS REPORTED THAT CARDIAC CHEST PAIN AND MYOCARIAL INFARCTION (MI) OCCURRED. IN (B)(6) 2009, THE PATIENT PRESENTED DUE TO STABLE ANGINA AND WAS REFERRED FOR CARDIAC CATHETERIZATION. THE TARGET LESION WAS LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA) WITH 80% STENOSIS, A LENGTH OF 24 MM AND REFERENCE VESSEL DIAMETER OF 4.0 MM. THE TARGET LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 4.00 X 28 MM STUDY STENT WITH 0% RESIDUAL STENOSIS. A NON-TARGET LESION WAS ALSO TREATED DURING INDEX PROCEDURE WITH THE PLACEMENT OF A NON-STUDY 3.0 X 28 MM DRUG ELUTING STENT TO THE DISTAL RCA AND RIGHT POSTERIOR ATRIOVENTRICULAR SEGMENT (R-PAV). SUBSEQUENTLY, THE SUBJECT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2014, THE PATIENT HAD CARDIAC CHEST PAIN. CARDIAC ENZYME ELEVATION WAS CONSISTENT WITH PROTOCOL DEFINITION OF MI WITH A PEAK TROPONIN OF 2.28UG/L, ULN=0.04UG/L. THE SUBJECT WAS HOSPITALIZED AND UNDERWENT ANGIOGRAPHY WITHOUT REVASCULARIZATION. THE SUBJECT WAS RECOVERING AND THE EVENT WAS RESOLVING AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381278 PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911528400 12325018

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization