BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT ?

    MDR report key: 3042520 · Received April 9, 2013

    Report

    Report Number
    2134265-2013-02127
    Event Type
    Injury
    Date Received
    April 9, 2013
    Date of Event
    March 8, 2013
    Report Date
    March 13, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: EXAMINATION OF THE RETURNED DEVICE REVEALED THAT THE BALLOON CATHETER WAS RETURNED ON THE WIRE AND THE STENT WAS DETACHED FROM THE BALLOON, HOWEVER THE STENT WAS NOT RETURNED FOR ANALYSIS. THE BALLOON WAS FOUND TO HAVE THE STENT IMPRESSIONS ON IT AND PILLOWING OF THE BALLOON INDICATING THAT THE STENT WAS CRIMPED PER PROCESS IN THE CORRECT LOCATION DURING MANUFACTURING. KINKS WERE ALSO IDENTIFIED ALONG THE ENTIRE LENGTH OF THE HYPOTUBE. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE FORCE BEING APPLIED TO THE DELIVERY SYSTEM. THE BALLOON AND TIP SECTIONS OF THE DEVICE WERE VISUALLY AND MICROSCOPICALLY EXAMINED AND NO ISSUES WERE NOTED WITH ITS PROFILE THAT COULD HAVE POTENTIALLY CONTRIBUTED TO THE COMPLAINT INCIDENT. SOLIDIFIED CONTRAST MEDIA WAS PRESENT WITHIN THE ENTIRE LENGTH OF THE INFLATION LUMEN, THEREFORE INDICATING THE DEVICE HAD BEEN PREPPED FOR USE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, STENT DISLODGMENT OCCURRED. THE PROMUS ELEMENT STENT 4.00X8MM WAS INSERTED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). THE BALLOON DELIVERY SYSTEM WAS INFLATED UP TO 6 ATM. DURING THIS ATTEMPT TO DEPLOY THE STENT, THE BALLOON WITH THE STENT PULLED BACK INTO THE LEFT MAIN. THE STENT DISLODGED FROM THE BALLOON AND LODGED IN THE CIRCUMFLEX ARTERY (CX). A 5X6MM NON COMPLIANT BALLOON WAS USED TO DEPLOY THE STENT IN THE CX ARTERY. ANOTHER SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT REMAINED STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, STENT DISLODGMENT OCCURRED. THE PROMUS ELEMENT STENT 4.00X8MM WAS INSERTED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). THE BALLOON DELIVERY SYSTEM WAS INFLATED UP TO 6 ATM. DURING THIS ATTEMPT TO DEPLOY THE STENT, THE BALLOON WITH THE STENT PULLED BACK INTO THE LEFT MAIN. THE STENT DISLODGED FROM THE BALLOON AND LODGED IN THE CIRCUMFLEX ARTERY (CX). A 5X6MM NON COMPLIANT BALLOON WAS USED TO DEPLOY THE STENT IN THE CX ARTERY. ANOTHER SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT REMAINED STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147482 PROMUS ELEMENT ? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911308400 15367331

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention