BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION?

    MDR report key: 4223240 · Received November 4, 2014

    Report

    Report Number
    2134265-2014-06578
    Event Type
    Injury
    Date Received
    November 4, 2014
    Date of Event
    October 7, 2014
    Report Date
    October 8, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE WAS NOT RECEIVED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATION. 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. SAME CASE AS MDR#2134265-2014-06579. IT WAS REPORTED THAT RESTENOSIS OCCURRED. IN (B)(6) 2011, THE PATIENT PRESENTED WITH STABLE ANGINA (CCS CLASSIFICATION: 2) AND WAS REFERRED FOR CARDIAC CATHETERIZATION. THE FIRST, 80% STENOSED, 22X3.00MM, TARGET LESION WAS A DE NOVO LESION LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD). THE FIRST TARGET LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF 2.5 MM X 24 MM ION US COA STENT. FOLLOWING POST-DILATATION, RESIDUAL STENOSIS WAS 0%. THE SECOND, 90% STENOSED, 14X3.00MM, TARGET LESION WAS A DE NOVO LESION LOCATED IN THE MID LAD. THE SECOND TARGET LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.50 MM X 16 MM ION US COA STENT. FOLLOWING POST-DILATATION RESIDUAL STENOSIS WAS 0%. THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2014, THE PATIENT WAS HOSPITALIZED WITH DIAGNOSIS OF CORONARY ARTERY DISEASE (CAD) POSITIVE STRESS TEST. THE 90% STENOSIS AT THE OVERLAPPING AREA OF THE PREVIOUSLY PLACED STUDY STENT LOCATED IN THE PROXIMAL LAD WAS TREATED WITH PLACEMENT OF 2.75 MM X 12 MM PROMUS PREMIER STENT, WITH 0% RESIDUAL STENOSIS. THE 90% DISTAL EDGE STENOSIS OF THE PREVIOUSLY PLACED STUDY STENT LOCATED IN THE MID LAD WAS TREATED WITH PLACEMENT 2.25 MM X 8 MM PROMUS PREMIER STENT, WITH 0% RESIDUAL STENOSIS. THE EVENT WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706145 ION? CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493902424250 14691126

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention