BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT¿ PLUS

    MDR report key: 2870210 · Received December 12, 2012

    Report

    Report Number
    2134265-2012-07569
    Event Type
    Malfunction
    Date Received
    December 12, 2012
    Date of Event
    October 14, 2012
    Report Date
    November 14, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION BY MANUFACTURER: A VISUAL AND MICROSCOPIC EXAMINATION FOUND NO ISSUES WITH THE DEVICE. NO KINKS OR DAMAGE WERE NOTICED ALONG THE SHAFT OF THE DEVICE. A VISUAL AND MICROSCOPIC EXAMINATION OF THE CRIMPED STENT FOUND NO ISSUES. THE BALLOON AND TIP SECTIONS OF THE DEVICE WERE VISUALLY AND MICROSCOPICALLY EXAMINED AND NO ISSUES WERE NOTED WITH THEIR PROFILES THAT COULD HAVE POTENTIALLY CONTRIBUTED TO THE EVENT. THE BALLOON WAS TIGHTLY WRAPPED AND WAS NOT SUBJECTED TO POSITIVE PRESSURE. DURING ANALYSIS WHEN A 0.015 INCH MANDREL WAS INSERTED THROUGH THE DEVICE, RESISTANCE WAS ENCOUNTERED DUE TO THE PRESENCE OF SOLIDIFIED BLOOD WITHIN THE LUMEN OF THE DEVICE. NO OTHER ISSUES WERE NOTED WITH THE DEVICE. 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

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, THE STENT DELIVERY SYSTEM BECAME STUCK TO A GUIDE WIRE. AN UNSPECIFIED TARGET LESION WAS TREATED BY SUCCESSFUL PLACEMENT OF THE 3.00X16MM PROMUS ELEMENT PLUS, MR STENT. DURING REMOVAL, FOLLOWING DEPLOYMENT, THE STENT DELIVERY SYSTEM BECAME STUCK TO AN UNKNOWN MANUFACTURE'S GUIDE WIRE. THE STENT DELIVERY SYSTEM AND GUIDE WIRE WERE REMOVED AS ONE UNIT. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OKAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, THE STENT DELIVERY SYSTEM BECAME STUCK TO A GUIDE WIRE. AN UNSPECIFIED TARGET LESION WAS TREATED BY SUCCESSFUL PLACEMENT OF THE 3.00X16MM PROMUS ELEMENT PLUS, MR STENT. DURING REMOVAL, FOLLOWING DEPLOYMENT, THE STENT DELIVERY SYSTEM BECAME STUCK TO AN UNKNOWN MANUFACTURER'S GUIDE WIRE. THE STENT DELIVERY SYSTEM AND GUIDE WIRE WERE REMOVED AS ONE UNIT. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OKAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS ELEMENT¿ PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911416300 0014867660

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR