BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION?

    MDR report key: 3892426 · Received June 24, 2014

    Report

    Report Number
    2134265-2014-03516
    Event Type
    Injury
    Date Received
    June 24, 2014
    Date of Event
    January 22, 2014
    Report Date
    May 27, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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: 2134265-2014-03515. (B)(4) STUDY. IT WAS REPORTED THAT ANGINA, MYOCARDIAL INFARCTION (MI) AND IN-STENT RESTENOSIS (ISR) OCCURRED. ON (B)(6) 2012, THE PATIENT WAS PRESENTED DUE TO UNSTABLE ANGINA WHICH WAS SUBSEQUENTLY DIAGNOSED AS MYOCARDIAL INFARCTION AND WAS REFERRED FOR CARDIAC CATHETERIZATION. THE INDEX PROCEDURE WAS PERFORMED. TARGET LESION # 1 WAS LONG DE NOVO LESION LOCATED IN THE MID SAPHENOUS VEIN GRAFT (SVG) TO FIRST DIAGONAL WITH 90% STENOSIS AND WAS 13 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.0 MM. THE LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 3.00 MM X 16 MM ION¿ STENT, WITH 0% RESIDUAL STENOSIS. THREE DAYS POST PROCEDURE, THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. ON (B)(6) 2014, THE PATIENT WAS PRESENTED WITH A HISTORY OF THREE TO FOUR MONTHS OF PROGRESSIVE ANGINA PECTORIS AND CORONARY ARTERY DISEASE. SUBSEQUENTLY, PATIENT WAS HOSPITALIZED. THE PATIENT¿S CARDIAC ENZYMES WERE FOUND TO BE ELEVATED AND MI OCCURRED. ELECTROCARDIOGRAM (ECG) REVEALED NON Q WAVE MI. IT WAS OBSERVED THAT THE PATIENT EXPERIENCED ISCHEMIC SYMPTOMS. FOLLOWING DAY, CORONARY ANGIOGRAPHY REVEALED 100% IN-STENT OCCLUSION OF SVG TO FIRST DIAGONAL. SIX DAYS FROM THE ONSET OF SYMPTOMS, THE OCCLUSION IN DISTAL RIGHT CORONARY ARTERY (RCA) WAS TREATED WITH PLACEMENT OF 3.0 MM X 12 MM PROMUS PREMIER DRUG ELUTING STENT AND THE 80% IN-STENT RESTENOSIS OF THE MID LEFT CIRCUMFLEX (LCX) (OF THE PREVIOUSLY PLACED 3 MM X 16 MM LIBERTE BARE METAL STENT) WAS TREATED WITH 2.75 MM X 16 MM PROMUS PREMIER DRUG ELUTING STENT. MEDICATION WAS GIVEN TO TREAT THE EVENT. TWO DAYS POST PROCEDURE, THE EVENT WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS AND THE WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367916 ION? CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493902416300 14828104

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R