BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT ¿

    MDR report key: 3103320 · Received May 9, 2013

    Report

    Report Number
    2134265-2013-02880
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    December 13, 2010
    Report Date
    March 29, 2013
    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

    AGE AT TIME OF EVENT: (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

    SAME PATIENT AS MDR ID# 2134265-2013-01284, 2134265-2013-01285. (B)(4). IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, A VESSEL DISSECTION OCCURRED. THE 3.5X25MM. 80% STENOSED TARGET LESION WAS LOCATED PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE LESION WAS PRE-DILATED AND TWO 3.5X12MM PROMUS ELEMENT STENTS WERE IMPLANTED IN THE PROXIMAL LAD RESULTING IN 0% RESIDUAL STENOSIS. A UNKNOWN 3.5X18MM DES WAS PLACED IN THE PROXIMAL LAD AND A UNKNOWN 3.0X13MM DES STENT WAS PLACED IN THE RAMUS. FOLLOWING PLACEMENT OF THE LAST 3.5X12MM PROMUS ELEMENT STENT A DISSECTION WAS NOTED IN THE OSTIAL LAD AND THROUGH THE OSTIUM OF THE INTERMEDIATE BRANCH DIRECTLY IN THE MAIN STEM AND THE OUTFLOW INTO THE RIGHT CIRCUMFLEX (RCX). A WIRE WAS PLACED THROUGH THE STENT STRUTS INTO THE INTERMEDIATE BRANCH AND BALLOON DILATION WAS PERFORMED WITH GOOD RESULT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204371 PROMUS ELEMENT ¿ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911312350 13228848

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention