BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT ¿

    MDR report key: 6088318 · Received November 9, 2016

    Report

    Report Number
    2134265-2016-10351
    Event Type
    Injury
    Date Received
    November 9, 2016
    Date of Event
    August 16, 2016
    Report Date
    October 26, 2016
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DATE CORRECTED FROM (B)(6) 2016 TO (B)(6) 2016. DEVICE AVAIL. FOR EVAL? UPDATED FROM YES TO NO. DEVICE RETURNED TO MFR.? CORRECTED FROM YES TO NO. DEVICE EVALUATED BY MANUFACTURER - IT WAS PREVIOUSLY REPORTED THAT THE DEVICE WAS RETURNED AND PENDING ANALYSIS. HOWEVER THE DEVICE WAS NOT RETURNED, THEREFORE ANALYSIS OF COMPLAINT DEVICE COULD NOT BE PERFORMED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE IS A COMBINATION PRODUCT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STENT DISLODGEMENT INSIDE PATIENT OCCURRED. THE 90% STENOSED, 40 X 2.5 MM TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 2.50 X 16 MM PROMUS ELEMENT ¿ DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. IT WAS NOTED THAT THE STENT GOT DISLODGED. THE STENT FAILED TO CAPTURE FROM THE BODY AND REMAINED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENTS' STATUS WAS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STENT DISLODGEMENT INSIDE PATIENT OCCURRED. THE 90% STENOSED, 40X2.5MM TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 2.50X16MM PROMUS ELEMENT DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. IT WAS NOTED THAT THE STENT GOT DISLODGED. THE STENT FAILED TO CAPTURE FROM THE BODY AND REMAINED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENTS' STATUS WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741366 PROMUS ELEMENT ¿ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911316250 18666929

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention