BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION?

    MDR report key: 3901074 · Received June 30, 2014

    Report

    Report Number
    2134265-2014-03667
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    March 11, 2014
    Report Date
    June 2, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. 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

    SAME CASE AS MDR ID# 2134265-2014-03669. (B)(4) STUDY. IT WAS REPORTED THAT A MYOCARDIAL INFARCTION (MI) OCCURRED. ON (B)(6) 2012, THE SUBJECT PRESENTED WITH UNSTABLE ANGINA AND WAS REFERRED FOR CARDIAC CATHETERIZATION AND INDEX PROCEDURE WAS PERFORMED. TARGET LESION #1 WAS A DE NOVO LESION LOCATED IN THE DISTAL RIGHT CORONARY ARTERY(RCA) WITH 90% STENOSIS AND WAS 16 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.75 MM. THE LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.75 MM X 16 MM ION¿ STENT. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0%. TARGET LESION #2 WAS A DE NOVO LESION LOCATED IN THE MID SAPHENOUS VEIN GRAFT (SVG) TO MID RCA WITH 70% STENOSIS AND WAS 20 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.5 MM. THE LESION WAS TREATED WITH DIRECT STENT PLACEMENT OF A 3.50 MM X 20 MM ION¿ STENT. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0%. THE SUBJECT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL THE NEXT DAY. ON (B)(6) 2014, THE SUBJECT¿S CARDIAC ENZYMES WERE ELEVATED AND MYOCARDIAL INFARCTION OCCURRED. THE PATIENT WAS SUBSEQUENTLY HOSPITALIZED. ECG REVEALED NON Q WAVE MI. THE SUBJECT DID NOT EXPERIENCE ANY ISCHEMIC SYMPTOMS. THE EVENT WAS CONSIDERED TO BE RESOLVED WITHOUT RESIDUAL EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381283 ION? CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493902416270 14838796

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization