BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT ?

    MDR report key: 3822472 · Received May 21, 2014

    Report

    Report Number
    2134265-2014-02736
    Event Type
    Injury
    Date Received
    May 21, 2014
    Date of Event
    August 26, 2013
    Report Date
    April 25, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). 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: 2134265-2014-02734. (B)(4). IT WAS REPORTED THAT RESTENOSIS OCCURRED. ON (B)(6) 2012, THE PATIENT PRESENTED WITH STABLE ANGINA. SUBSEQUENTLY, THE INDEX PROCEDURE WAS PERFORMED. THE 90% STENOSED, 25.9X2.3MM, NEW, ECCENTRIC, TYPE C, DIFFUSE LESION WITH MORE THAN 2CM IN LENGTH, WITH A OVER 45 DEGREE BEND AND UNDER 90 DEGREE AND TIMI 3 FLOW TARGET LESION WAS LOCATED IN THE NON CALCIFIED AND SEVERELY TORTUOUS IN PROXIMAL MID RIGHT CORONARY ARTERY (RCA). THE LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 3.5X 28MM PROMUS ELEMENT STENT AT 14 ATMOSPHERES. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0% WITH TIMI 3 FLOW. TARGET LESION #2 WAS A 75% STENOSED, 26.6X2.1MM, NEW, ECCENTRIC, TYPE C, DIFFUSE LESION WITH MORE THAN 2CM IN LENGTH, WITH UNDER 45 DEGREE BEND AND TIMI 3 FLOW, AND WAS LOCATED IN THE NON CALCIFIED AND MILDLY TORTUOUS IN PROXIMAL DISTAL RIGHT CORONARY ARTERY (RCA). TARGET LESION #2 WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 3.00 X 28MM PROMUS ELEMENT STENT AT 12 ATMOSPHERES. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0% WITH TIMI 3 FLOW. ON (B)(6) 2013, THE PATIENT PRESENTED WITH CORONARY RESTENOSIS IN THE MID AND DISTAL RCA. THE PHYSICIAN PERFORMED PERCUTANEOUS CORONARY INTERVENTION (PCI) TO TREAT THE EVENT. ONE DAY POST PROCEDURE, THE OUTCOME OF THE EVENT WAS GOOD AND PATIENT'S STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303719 PROMUS ELEMENT ? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911328300

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention