BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT ¿

    MDR report key: 3021534 · Received March 26, 2013

    Report

    Report Number
    2134265-2013-02039
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    February 24, 2013
    Report Date
    February 25, 2013
    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

    (B)(4). 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

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE A STENT DISLODGEMENT OCCURRED. ACCESS WAS OBTAINED VIA THE RADIAL ARTERY. THE 90% STENOSED, 3.5X20MM ECCENTRIC AND DE NOVO TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD) WHICH HAD A SIGNIFICANT BEND OF 45 TO 90 DEGREES. THE LESION WAS PREDILATED WITH A 2.5X15MM NON BSC BALLOON AND THEN A 3.50X20MM PROMUS ELEMENT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LAD; HOWEVER, THE STENT DISLODGED FROM THE SDS AND MIGRATED TO AN ARTERY IN THE RIGHT LEG OF THE PATIENT. THE PHYSICIAN DEPLOYED A 3.5X20MM OMEGA STENT IN THE LAD AND THEN THE PATIENT WAS TAKEN TO THE OPERATING ROOM TO REMOVE THE DISLODGED PROMUS ELEMENT STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CURRENT CONDITION IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123481 PROMUS ELEMENT ¿ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911320350 15444553

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention 2.5X15MM SAPHIRE BALLOON CATHETER