BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

    MDR report key: 3090641 · Received May 2, 2013

    Report

    Report Number
    2134265-2013-03376
    Event Type
    Injury
    Date Received
    May 2, 2013
    Date of Event
    April 5, 2013
    Report Date
    April 5, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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 MFR #: 2134265-2013-03377. IT WAS REPORTED THAT DURING A CORONARY STENTING PROCEDURE, STENT DEFORMATION AND A VESSEL DISSECTION OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. AN UNSPECIFIED SIZE PROMUS ELEMENT PLUS STENT WAS USED TO TREAT THE TARGET LESION. ANOTHER UNSPECIFIED SIZE PROMUS ELEMENT PLUS STENT WAS THEN USED BUT WAS UNABLE TO CROSS THROUGH THE PREVIOUSLY DEPLOYED STENT. THE PHYSICIAN THOUGHT STENT DEFORMATION OCCURRED. A DISSECTION OCCURRED AND MULTIPLE STENTS WERE IMPLANTED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191496 PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY UNK717

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention