BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT? PLUS

    MDR report key: 3524098 · Received December 17, 2013

    Report

    Report Number
    2134265-2013-08996
    Event Type
    Injury
    Date Received
    December 17, 2013
    Date of Event
    November 19, 2013
    Report Date
    November 22, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: RECEIVED FOR ANALYSIS WAS THE STRETCHED DETACHED STENT CAUGHT IN A SNARE. THE DELIVERY DEVICE WAS NOT RECEIVED FOR ANALYSIS. AN EXAMINATION OF THE STENT FOUND THAT THE STENT STRUTS WERE SEVERELY STRETCHED AND MISALIGNED. 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS OBTUSE MARGINAL BRANCH (OMB) VESSEL. A 2.50X16MM PROMUS ELEMENT PLUS STENT WAS SELECTED TO TREAT THE LESION. WHEN THE DEVICE WAS ADVANCED TO THE OMB, IT CAME INTO CONTACT WITH THE EDGE OF THE PREVIOUSLY IMPLANTED NON BSC STENT, WHOSE STRUT HAD JAILED THE LEFT MAIN TRUNK. DESPITE SEVERAL ATTEMPTS, THE DEVICE COULD NOT CROSS THE LESION. WHEN THE PHYSICIAN ATTEMPTED TO RETRACT THE DEVICE TO THE UNSPECIFIED THE GUIDE CATHETER, THE STENT DISLODGED. THE STENT WAS REMOVED THROUGH SNARING PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS OBTUSE MARGINAL BRANCH (OMB) VESSEL. A 2.50X16MM PROMUS ELEMENT¿ PLUS STENT WAS SELECTED TO TREAT THE LESION. WHEN THE DEVICE WAS ADVANCED TO THE OMB, IT CAME INTO CONTACT WITH THE EDGE OF THE PREVIOUSLY IMPLANTED NON BSC STENT, WHOSE STRUT HAD JAILED THE LEFT MAIN TRUNK. DESPITE SEVERAL ATTEMPTS, THE DEVICE COULD NOT CROSS THE LESION. WHEN THE PHYSICIAN ATTEMPTED TO RETRACT THE DEVICE TO THE UNSPECIFIED THE GUIDE CATHETER, THE STENT DISLODGED. THE STENT WAS REMOVED THROUGH SNARING PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    658589 PROMUS ELEMENT? PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493918416250 16072225

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention