BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT¿ PLUS

    MDR report key: 3112216 · Received May 14, 2013

    Report

    Report Number
    2134265-2013-03160
    Event Type
    Injury
    Date Received
    May 14, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 16, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. (B)(4). DEVICE EVALUATION BY MANUFACTURER: 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 PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE OBTUSE MARGINAL. A 6F NON-BSC GUIDE CATHETER AND A FULLY DEPLOYED 3.5X5.5MM FILTERWIRE WERE ENGAGED IN THE SAPHENOUS VEIN GRAFT. THE 3.50X16MM PROMUS ELEMENT PLUS STENT WAS THEN DEPLOYED AT 20 ATM FOR 30 SECONDS. THE STENT DELIVERY SYSTEM WAS REMOVED AND ANGIOGRAM WAS PERFORMED. THE PROMUS ELEMENT STENT APPEARED WELL APPOSED. THE FILTERWIRE WAS THEN REMOVED SUCCESSFULLY THEN ANGIOGRAM WAS PERFORMED AND REVEALED THAT THE STENT HAD COMPRESSED ON ITSELF AND HAD STENT DAMAGE. THE STENT DAMAGE WAS TREATED WITH DEPLOYMENT OF A 4.0X8MM PROMUS ELEMENT PLUS STENT AT 11 ATM FOR 30 SECONDS. ANGIOGRAM WAS PERFORMED AND THE STENT APPEARED WELL APPOSED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED THAT THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212839 PROMUS ELEMENT¿ PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911416350 15879712

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention