BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION¿

    MDR report key: 2992769 · Received March 7, 2013

    Report

    Report Number
    2134265-2013-01232
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 8, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. (B)(6). THE DEVICE WAS NOT RECEIVED 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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT NO ACTION WAS TAKEN TO TREAT THE EVENT AND ON (B)(6) 2013, THE EVENT WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS.

    Description of Event or Problem · 1

    (B)(4) STUDY. IT WAS REPORTED THAT POST A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, THE PATIENT EXPERIENCED CONGESTIVE HEART FAILURE. IN (B)(6) 2012 THE PATIENT PRESENTED WITH STABLE ANGINA AND CARDIAC CATHETERIZATION WAS RECOMMENDED. THE 80% STENOSED AND 14MM LONG TARGET LESION WAS LOCATED IN THE MID RIGHT CORONARY ARTERY WITH A REFERENCE VESSEL DIAMETER OF 3.8MM. THE TARGET LESION WAS TREATED WITH DIRECT STENT PLACEMENT OF A 4.0X20MM PROMUS ELEMENT STUDY STENT, RESULTING IN 0% RESIDUAL STENOSIS. THE FOLLOWING DAY THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2013 THE PATIENT PRESENTED WITH CONGESTIVE HEART FAILURE AND WAS HOSPITALIZED. IT UNSPECIFIED HOW THE PATIENT WAS TREATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97566 ION¿ CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493902420400 14074211

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Hospitalization