BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION¿

    MDR report key: 2872249 · Received December 13, 2012

    Report

    Report Number
    2134265-2012-07917
    Event Type
    Injury
    Date Received
    December 13, 2012
    Date of Event
    January 18, 2012
    Report Date
    November 16, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER: 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

    (B)(4). SAME CASE AS 2134265-2012-07916; 2134265-2012-07585; 2134265-2012-07586; 2134265-2012-07584. IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED ELEVATED ENZYMES. LESION 1 WAS LOCATED IN THE PROXIMAL LEFT CIRCUMFLEX WITH 95% STENOSIS AND WAS 15 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.5 MM. THE PHYSICIAN TREAT THE LESION WITH PRE-DILATATION AND PLACEMENT OF A 2.25 MM X 16 MM, 2.25 MM X 20 MM AND 2.50 MM X 8 MM ION US COA STENTS. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0%. THE STAGED PROCEDURE WAS PERFORMED 6 DAYS LATER. THE TARGET LESION WAS LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY WITH 70% STENOSIS AND WAS 15 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.0 MM. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATATION AND PLACEMENT OF A 3.50 MM X 16 MM AND 3.0 MM X 16 ION US COA STENTS. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0%. AT 7 DAYS POST INDEX PROCEDURE/PRIOR TO DISCHARGE, ELEVATED CARDIAC ENZYME VALUES WERE OBSERVED (PEAK CK-MB= 9.3 NG/ML; ULN= 3.6 NG/ML). THE PATIENT PRESENTED WITH A MYOCARDIAL INFARCTION. THE EVENT WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS AND THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ION¿ CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493902320220 14019941

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other 2.50X8MM ION STENT| 2.25X16MM ION STENT| 3.50X16M ION STENT| 3.00X16MM ION STENT