BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS PREMIER?

    MDR report key: 4220898 · Received November 3, 2014

    Report

    Report Number
    2134265-2014-06515
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    October 1, 2014
    Report Date
    October 6, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, 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 BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. 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 2134265-2014-06848. (B)(4) STUDY. IT WAS REPORTED THAT ANGINA AND IN-STENT RESTENOSIS (ISR) OCCURRED. IN APRIL 2014, THE PATIENT PRESENTED WITH ACUTE MYOCARDIAL INFARCTION (MI) AND THE 3.00 X 20MM PROMUS PREMIER¿ DRUG ELUTING STENT WAS DEPLOYED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY EXTENDING TO 1ST DIAGONAL. IN (B)(6) 2014, THE PATIENT PRESENTED WITH SYMPTOMS OF UNSTABLE ANGINA AND CARDIAC CATHETERIZATION WAS RECOMMENDED. AT THE TIME OF THE EVENT, THE SUBJECT WAS ON ASPIRIN AND CLOPIDOGREL. THE STUDY DRUG WAS LAST TAKEN IN (B)(6) 2013. SUBSEQUENTLY, CORONARY ANGIOGRAPHY WAS PERFORMED AND REVEALED 80% STENOSIS IN MID LAD AND 90% ISR OSTIUM OF THE 1ST DIAGONAL OF THE PREVIOUSLY PLACED 3.00 X 20MM PROMUS PREMIER¿ STENT. THE PROXIMAL LAD AND EXTENDING INTO 1ST DIAGONAL WAS TREATED WITH CUTTING BALLOON ANGIOPLASTY, RESULTING IN 0% RESIDUAL STENOSIS. AT THE TIME OF REPORTING, THE EVENT WAS CONSIDERED RECOVERING/ RESOLVING. ASPIRIN AND OTHER ANTIPLATELET MEDICATIONS WERE RECOMMENDED FOR ANOTHER SIX MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702167 PROMUS PREMIER? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY UNK758

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention