BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT ¿

    MDR report key: 2904125 · Received January 9, 2013

    Report

    Report Number
    2134265-2012-08312
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    December 11, 2012
    Report Date
    December 11, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: (B)(6). DEVICE IS 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# 2134265-2012-08313. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY STENTING TREATMENT PROCEDURE, STENT DISLODGEMENT AND STENT MALPOSITION OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE CALCIFIED AND MODERATELY TORTUOUS MID RIGHT CORONARY ARTERY (RCA). IVUS WAS PERFORMED. THE LESION WAS PREDILATED WITH AN UNSPECIFIED BALLOON CATHETER. A 3.5 X 38MM PROMUS ELEMENT STENT WAS IMPLANTED. THEN ANOTHER PROMUS ELEMENT 3.5 X 38MM STENT DELIVERY SYSTEM WAS ADVANCED TO THE PROXIMAL OF THE DEPLOYED STENT, BUT THEY WERE UNABLE TO CROSS THE LESION. THE STENT WAS IMPLANTED, BUT NOT IN THE INTENDED POSITION WITH A SPACE BETWEEN THE 2 STENTS. THE 3.5 X 28MM PROMUS ELEMENT MR WAS ADVANCED, BUT WAS UNABLE TO CROSS THE LESION. UPON WITHDRAWAL OF THE SDS THE STENT DISLODGED INSIDE THE PATIENT DUE TO CONTACT WITH THE MICROCATHETER AND STENT. THE STENT WAS RETRIEVED WITH A SNARE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10939 PROMUS ELEMENT ¿ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911328350 15207976

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention